News Releases AACR’s Magazine for Patients and Survivors, <i>Cancer Today,</i> Launches a New Websitehttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1148

Cancer Today (CancerTodayMag.org) has launched a new website, making it easier for the public to find late-breaking news about cancer research, new cancer therapies, prevention strategies, and clinical trials. Cancer Today, published quarterly by the American Association for Cancer Research (AACR), is the nation’s leading magazine for cancer patients, survivors, and caregivers.

“Through this new website, we expect CancerTodayMag.org to become a destination site for anyone who wants to learn more about cancer,” said Kevin McLaughlin, Cancer Today executive editor. “The website will allow us to cover late-breaking news like FDA drug approvals more quickly and offer a platform for more content than is possible in a quarterly magazine.

CancerTodayMag.org will deliver the same insightful, practical articles that our readers have come to expect from the magazine,” McLaughlin said, “and will extend our mission to serve cancer patients, survivors, and caregivers.”

The Cancer Today website continues to offer the same in-depth analysis of cancer issues, such as off-label prescribing and survivorship concerns, as the printed edition, as well as original stories and videos. The website also provides a filter that readers can use to find what’s relevant to them—advice on their cancer, the latest research updates, or inspiration from reading profiles of cancer survivors and advocates. The site also features Cancer Talk, a blog that lets readers interact with the magazine’s editors and contributors.

“A new and improved Cancer Today website will bolster the AACR’s visibility among the general public,” said Rick Buck, senior director of AACR Communications and Public Relations. “The AACR is the first and largest professional organization in the world dedicated to the prevention and cure of all cancers, and we’ve made a commitment to raise public awareness of the amazing progress being made to help save lives from cancer. The new Cancer Today website will play a vital role in meeting that objective.”

The website’s bold and clear design, created by AAJ Design of Philadelphia, enhances user experience and is easily readable on all platforms. Frequent use of the AACR’s signature green color better integrates the site with the association’s website and the AACR Foundation website. The Cancer Today website was developed by Edgimo, a Boulder, Colorado-based digital strategies firm.

McLaughlin added, “We’re so excited to unveil the new website, and we look forward to continuing to serve the cancer community with timely and accurate news and information about cancer in print and online.”

 

Press Release Published Date: 2/12/2018 9:00 AM
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Loftus, EileenMon, 12 Feb 2018 02:17:25
The AACR Announces AACR-Johnson & Johnson Lung Cancer Innovation Science Grantshttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1147

​PHILADELPHIA — The American Asso​ciation for Cancer Research (AACR) is extremely proud to announce the launch of the AACR-Johnson & Johnson Lung Cancer Innovation Science Grants to stimulate research aimed at eradicating this devastating disease. This exciting new funding opportunity, which is supported by the Johnson & Johnson Lung Cancer Initiative, will ignite scientific innovation and transformational advances against lung cancer.

A total of $4.5 million will be made available in research funding in support of meritorious research projects. Three multi-institutional research teams that seek novel approaches to the prevention, interception, and cure of lung cancer will each be awarded up to $1.5 million over a period of three years. The deadline for submission is Friday, March 2, at 1 p.m. Eastern Standard Time. Research projects will begin on July 1, 2018.

“Lung cancer is the leading cause of cancer death worldwide, and more research is urgently needed if we are to markedly reduce incidence and mortality from this complex disease. These grants will identify innovative strategies to eliminate behaviors that increase lung cancer risk, devise new ways to intercept a lung cancer-causing process before lung cancer occurs, and develop effective treatments that offer the potential for a cure,” said Margaret Foti, PhD, MD (hc), chief executive officer of the AACR.

Proposals submitted for this important funding opportunity should consider the concepts that lung cancer is often caused by behaviors that lead to: chronic exposure to respiratory carcinogens that produce cellular/genomic damage; chronic inflammation; alterations in innate and adaptive immunity; and changes in the pulmonary microbiome. Consequently, these events may trigger the escape of transformed cells from immune surveillance. Proposals that characterize premalignant lesions or that substantially improve the detection of lung cancer at more curable stages will also be prioritized for funding.

Grant applications will be accepted from multi-institutional teams, composed of principal investigators from at least two, but no more than three, different institutions. The recipients will formally accept the grants at the AACR Annual Meeting 2018, to be held April 14-18 in Chicago.

Applications must be submitted by 1 p.m. Eastern Standard Time, March 2, 2018, using the proposalCENTRAL website. Further details are available online. Additional inquiries may be directed to the AACR’s Scientific Review and Grants Administration department, at grants@aacr.org.

Press Release Published Date: 2/1/2018 4:10 AM
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Loftus, EileenThu, 1 Feb 2018 09:21:14
American Association for Cancer Research Provides Comments to the FDA on Nicotine Replacement Therapieshttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1146

​WASHINGTON, D.C.On Friday, January 26, the U.S. Food and Drug Administration (FDA) held a public hearing on the FDA’s approach to evaluating the safety and efficacy of nicotine replacement therapy (NRT) products, including how to promote innovation in these products and how they should be used and labeled. AACR Tobacco and Cancer Subcommittee member Dorothy K. Hatsukami, PhD, Associate Director of Cancer Prevention and Control at the University of Minnesota Masonic Cancer Center, presented a summary of the AACR’s Tobacco and Cancer Subcommittee’s comments to the FDA. The summary of Dr. Hatsukami’s presentation is below.

The AACR Tobacco & Cancer Subcommittee recommends improving the appeal and nicotine delivery of NRT to increase uptake and efficacy of these smoking cessation products. The subcommittee also recommends approving NRT for combination treatments, including use of short-acting and long-acting medications, and considering long-term use of NRT to completely substitute for cigarettes in order to reduce harm to health or to present relapse to smoking. Furthermore, since almost half of smokers who are planning to quit in next 12 months are interested in gradual reduction, the subcommittee recommends that the FDA consider a reduce-to-quit approach with NRT, which has been shown to be more effective than placebo. The AACR is not recommending cigarette reduction that does not lead to complete cigarette cessation as a harm reduction approach. 

Finally, there are significant misperceptions or lack of knowledge among smokers and health care providers regarding the safety of NRT. These misperceptions impact uptake and optimal use of NRT, which ultimately leads to the reduced efficacy of smoking cessation products. Therefore, the Subcommittee recommends adding a simplified label on NRT packages that conveys their relative risk compared to cigarettes, such as “Nicotine replacement therapy is substantially less harmful to health than cigarette smoking,” to clarify these misperceptions and increase smokers’ willingness to use NRT as part of their attempt to quit smoking.

Dr. Hatsukami’s presentation will be archived here. The slides from her presentation to the FDA are available here.

Press Release Published Date: 1/29/2018 4:30 AM
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Loftus, EileenMon, 29 Jan 2018 09:57:18
High Body Fat Levels Are Associated With Increased Breast Cancer Risk in Postmenopausal Women With Normal BMI http://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1142

​​​Editor’s note: Click here to read the full abstracts for studies featured in the AACR’s press program for the Obesity and Cancer conference.

AUSTIN, Texas — Among postmenopausal women with normal body mass index (BMI), those with higher body fat levels had an increased risk for invasive breast cancer, according to data presented at the American Association for Cancer Research Special Conference Obesity and Cancer: Mechanisms Underlying Etiology and Outcomes, held Jan. 27-30.

"It was previously unknown whether individuals who have a normal BMI but increased body fat have an increased risk of developing cancer," said Neil Iyengar, MD, medical oncologist at Memorial Sloan Kettering Cancer Center. "Our findings show that the risk of invasive breast cancer is increased in postmenopausal women with normal BMI and higher levels of body fat, meaning that a large proportion of the population has an unrecognized risk of developing cancer." Neil Iyengar, MD

"Body fat levels are typically measured via BMI, which is a ratio of weight to height. While BMI may be a convenient method to estimate body fat, it is not an exact way to determine whole body fat levels, as muscle mass and bone density cannot be distinguished from fat mass," said Thomas Rohan, MBBS, PhD, DHSc, professor and chair, Department of Epidemiology and Population Health at Albert Einstein College of Medicine. Dual energy X-ray absorptiometry (DXA) is a technology that can specifically measure for fat content, resulting in a more accurate assessment of total body fat levels, he explained.

The investigators analyzed data from the Women's Health Initiative (WHI), an observational study that follows the health of postmenopausal women ages 50-79. The study included participants who had a normal BMI (between 18.5 to <25.0) with baseline DXA measurements and no history of breast cancer.

During the median 16 years of follow-up, study participants were assessed for the development of invasive breast cancer, and cancer cases were evaluated for estrogen receptor (ER) positivity. Of the 3,460 participants in the study, 182 developed invasive breast cancer during follow-up; 146 of these cases were ER-positive.

In multivariable analysis, compared to women in the lowest quartile of whole body fat mass, women in the highest quartile had approximately a doubling in the risk for ER-positive breast cancer.

Iyengar and colleagues also found that the risk of ER-positive breast cancer increased by 35 percent for each 5-kilogram increase in whole body fat, despite having a normal BMI. "It is also notable that the level of physical activity was lower in women with higher amounts of body fat," said Iyengar. "This suggests that physical activity may be important even for those who are not obese or overweight."

"These findings will probably be surprising to many doctors and patients alike, as BMI is the current standard method to assess the risks for diseases related to body weight," said Andrew Dannenberg, MD, associate director of Cancer Prevention at the Sandra and Edward Meyer Cancer Center of Weill Cornell Medicine. "We hope that our findings will alert women to the possibility of increased breast cancer risk related to body fat, even if they have a healthy weight."

A limitation to the study is that the researchers were unable to analyze how changes in body fat over time related to breast cancer risk. The authors noted that findings from this study are limited to postmenopausal women and are not generalizable to other populations or other cancers.

Several authors of this study are supported by the Breast Cancer Research Foundation. The WHI program is funded by the National Heart, Lung, and Blood Institute, National Institutes of Health, U.S. Department of Health and Human Services. The investigators declare no conflicts of interest.

Press Release Published Date: 1/25/2018 7:05 PM
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Loftus, EileenThu, 25 Jan 2018 03:57:07
Predicted Rise in Canadian Obesity Rate May Lead to Higher Cancer Burdenhttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1143

​​Editor’s note: Click here to read the full abstracts for studies featured in the AACR’s press program for the Obesity and Cancer conference.

AUSTIN, Texas — Reducing the number of overweight and obese Canadians by 50 percent could potentially prevent a cumulative 59,829 cases of cancer by 2042, according to estimates presented at the American Association for Cancer Research Special Conference Obesity and Cancer: Mechanisms Underlying Etiology and Outcomes, held Jan. 27-30.

“Cancer is the leading cause of death in Canada, and several cancer types have strong associations with excess body weight; yet the number of Canadians who are overweight or obese is increasing,” said Darren Brenner, PhD, assistant professor in the departments of Oncology and Community Health Sciences at Cumming School of Medicine, University of Calgary, Alberta, Canada. Darren Brenner, PhD

Brenner is part of a collaborative group from multiple institutions across Canada working together on the Canadian Population Attributable Risk of Cancer Project (ComPARe). The goal of this project is to estimate how many new cases of cancer are caused by 25 different risk factors, including lifestyle factors such as diet, body size, and physical activity, and how many could be avoided over the next 30 years if changes in behaviors were made, Brenner said.

Using population-level data and statistical approaches, Brenner and colleagues first projected the number of Canadians with excess body weight (overweight plus obesity) over the next 30 years. They found that in 2011, the prevalence of overweight and obesity in Canada was 32.7 percent and 17.8 percent, respectively.
“If current trends continue, by 2032, the prevalence of overweight and obesity will be 31.2 percent and 27.9 percent, respectively,” Brenner noted.

Using data from 2012, the researchers estimated that 8,626 cancer cases (3,886 for men and 4,740 for women) were attributable to excess body weight, accounting for 9.4 percent of the 91,373 associated cancer cases (8.8 percent for men and 10.1 percent for women). The researchers then projected that in 2042, 15,747 cancer cases for men and 10,312 cancer cases for women would be attributable to excess body weight, accounting for 10.8 percent of the 146,260 associated cancer cases in men and 11.2 percent of the 92,233 associated cancer cases in women.

“After projecting the future prevalence of excess body weight and cancer incidence attributable to excess body weight, we asked how the trends in excess body weight could be influenced by effective interventions,” said Brenner.

The team studied scenarios of interventions that would reduce the prevalence of excess body weight by 10, 25, and 50 percent by 2042 and then estimated the cancer burden under these new scenarios. “The difference in cancer incidence between our projected data and our ‘prevention’ scenarios would be the future potential for cancer prevention,” Brenner explained. The scenarios were meant to simulate population-level implementation of existing intervention programs, policy changes to impact healthy behavior decision making, or a return to obesity levels in 1990.

The researchers found that if it is possible to intervene on excess body weight and reduce the prevalence of both overweight and obesity by 10, 25, and 50 percent, it would be possible to prevent 1,660, 4,150, and 8,300 cancer cases in 2042, and a cumulative number of 11,966, 29,914, and 59,829 cancer cases by 2042, respectively.

“Our data provide alarming estimates of the consequences of inaction in Canada,” Brenner said. “The results of this study will inform policymakers, public health officials, and the Canadian population with targets to lower future cancer burden.”

According to Brenner, limitations of the study are that the estimates of overweight and obesity used in this study were based on self-reported data, and that the researchers assumed a latency period of 10 years between exposure to a risk factor and cancer diagnosis, which is a potential over-simplification since the latency period for some exposures is longer.

This study was funded by a Canadian Cancer Society Research Institute Partner Prevention Research Grant. Brenner declares no conflict of interest.

Press Release Published Date: 1/25/2018 7:05 PM
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Loftus, EileenThu, 25 Jan 2018 04:04:32
Quality of Children’s Sleep May Affect Eating Habits and Weighthttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1144

Editor’s note: Click here to read the full abstracts for studies featured in the AACR’s press program for the Obesity and Cancer conference.

AUSTIN, Texas — Several measures of poor sleep quality were associated with higher body mass index (BMI) in children, according to data presented at the American Association for Cancer Research Special Conference Obesity and Cancer: Mechanisms Underlying Etiology and Outcomes, held Jan. 27-30.

About one in five children between the ages of 6 and 19 is obese, according to recent statistics from the Centers for Disease Control and Prevention. The percentage of U.S. children with obesity has more than tripled since the 1970s, with significant immediate and long-term effects.

“Childhood obesity very often leads to adult obesity,” said the study’s lead author, Bernard Fuemmeler, PhD, MPH, professor and associate director for cancer prevention and control at Virginia Commonwealth University’s Massey Cancer Center. “This puts them at greater risk of developing obesity-related cancers in adulthood.” Bernard Fuemmeler, PhD, MPH

Fuemmeler explained that previous research has shown that sleep patterns play a role in obesity in adults, but most research exploring the connection between sleep and obesity in children has focused on the duration of sleep, rather than the way quality of sleep or circadian patterns affect eating behaviors and weight. 

In this study, Fuemmeler and colleagues enrolled 120 children whose mothers had participated in the Newborn Epigenetic Study, a federally funded project that examines how environmental exposures and nutrition, both pre-birth and during early childhood, affect how genes work. The average age of the children was 8. Researchers controlled for age, sex, race, and maternal education as an indicator of socioeconomic status.

To track the sleep-wake cycle, the children wore accelerometers continuously for 24 hours per day for a period of at least five days. To gauge eating habits, children completed the “eating in the absence of hunger test.” Children ate a meal and reported when they were full; the researchers then tracked how much food they ate once they had reached the point of satiety.

The researchers found:

  • Shorter sleep duration, measured in hours, was associated with a higher BMI z-score (body mass index adjusted for age and sex). Each additional hour of sleep was associated with a .13 decrease in BMI z-score, and with a 1.29 centimeter decrease in waist circumference.
  • More fragmented rest-activity rhythms and increased intradaily variability, a measure of the frequency and extent of transitions between sleep and activity, were also associated with greater waist circumferences.
  • Earlier onset of the most active period during daytime, diurnal activity, was associated with higher intake of calories once the children had reached the point of satiety.

Overall, Fuemmeler said, the study results indicate that while sleep duration is important, examining markers of sleep quality may also be useful in designing childhood obesity prevention strategies.

“Today, many children are not getting enough sleep,” Fuemmeler said. “There are a number of distractions, such as screens in the bedroom, that contribute to interrupted, fragmented sleep. This, perpetuated over time, can be a risk factor for obesity. Because of the strong links between obesity and many types of cancer, childhood obesity prevention is cancer prevention, in my view.”

Fuemmeler said that while further research is necessary to understand more about the way poor sleep affects weight, families would benefit from following guidelines established by the American Academy of Pediatrics.

The study’s primary limitation is that it did not include prospective data that might have helped researchers assess whether sleep quality influences weight gain or weight in children affects their sleep. Fuemmeler said that data will be encompassed in future studies.

Scott Kollins, PhD, and Jessica Lunsford-Avery, PhD, Duke University, also contributed to the development of this work. The study was funded by a grant from the National Institute of Child Health and Human Development. Fuemmeler and co-authors have no conflicts of interest.

Press Release Published Date: 1/25/2018 7:05 PM
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Loftus, EileenThu, 25 Jan 2018 04:16:19
Obese Men May Have Higher Chance of Recurrence Following Radical Prostatectomyhttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1145

Editor’s note: Click here to read the full abstracts for studies featured in the AACR’s press program for the Obesity and Cancer conference.

AUSTIN, Texas — Among men with prostate cancer who underwent radical prostatectomy (RP), those who were obese had a higher risk of biochemical recurrence, according to data presented at the American Association for Cancer Research Special Conference Obesity and Cancer: Mechanisms Underlying Etiology and Outcomes, held Jan. 27-30.

Biochemical recurrence was defined as two consecutive prostate-specific antigen (PSA) measurements of ≥ 0.2 ng/mL after prostatectomy, which is indicative of recurrent prostate cancer.

“Obesity and metabolic syndrome have become increasingly widespread in our society,” said Arash Samiei, MD, basic scientist and clinical researcher at the Department of Urology at the Allegheny Health Network in Pittsburgh. “Prostate cancer is the most common cancer in men, and up to 30 percent of patients will develop recurrence after RP. We wanted to investigate the association between obesity and metabolic syndrome with the oncological outcome following prostate removal.” Arash Samiei, MD

Samiei explained that previous studies linking high body mass index (BMI) and metabolic syndrome to increased risk of recurrence following RP have been controversial. To build upon previous research, Samiei and colleagues performed a large study with long-term follow-up to conduct a more comprehensive analysis.

Samiei and colleagues conducted a retrospective study of all RPs (1,100 surgeries) performed by two surgeons at Allegheny General Hospital in Pittsburgh between 2003 and 2013. They analyzed Gleason score, pathologic stage, pre-operative PSA, biochemical recurrence time, surgical margin status, and metabolic factors, such as fasting glucose, triglycerides, cholesterol levels, including HDL, pre-operative BMI, and blood pressure.

Patients were categorized as having low-, intermediate-, or high-risk prostate cancer based on pathological staging and grading of the disease. Metabolic syndrome positivity was determined using the World Health Organization (WHO) classification, where at least three out of the following five factors are simultaneously present in an individual – insulin resistance or type 2 diabetes, obesity, high cholesterol or low HDL levels, high triglycerides, and hypertension. The average age of the patient at diagnosis was 60 years, and the average follow-up time was 48 months.

Among the patients studied, 34 percent were obese, as defined by BMI, and 19 percent had metabolic syndrome.

Samiei and colleagues found a higher percentage of obese patients in the high-risk group (41.2 percent of high-risk patients) compared to obese patients in the low/intermediate group (32 percent of low/intermediate risk patients). Additionally, biochemical recurrence was higher in patients with BMI ≥30 (32.4 percent) compared to patients with BMI <30 (16.9 percent). Finally, patients with metabolic syndrome had more than four-fold increased risk of biochemical recurrence compared to those without metabolic syndrome.

“Our study indicates that prostate cancer patients who are obese or have metabolic syndrome undergoing RP may have a higher chance for recurrence of the disease, and these individuals should have more focused follow-up care,” said Samiei. “By preventing metabolic syndrome, men with prostate cancer may have a higher chance of a favorable oncological outcome following surgery.”

Samiei noted that because this was an observational, retrospective study, future work should include the design of large, multi-center prospective studies.

This study was sponsored by the Western Pennsylvania Prostate Cancer Foundation. Samiei declares no conflicts of interest.

Press Release Published Date: 1/25/2018 7:05 PM
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Loftus, EileenThu, 25 Jan 2018 04:23:49
AACR Names Dr. Chi Van Dang as Editor-in-Chief of Cancer Research Journal http://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1140

PHILADELPHIA — The American Associa​tion for Cancer Research (AACR) is pleased to announce the appointment of Chi Van Dang, MD, PhD, as editor-in-chief of its Cancer Research journal. Published under different titles in its early years, Cancer Research was the first English-language journal to be published in the field of oncology and is arguably the most influential cancer research journal in the world today.

Dang is the scientific director of the Ludwig Institute for Cancer Research, an international, not-for-profit organization of distinguished scientists dedicated to preventing and controlling cancer.  He is also a professor in the Molecular and Cellular Oncogenesis Program at The Wistar Institute in Philadelphia. Dang officially began his term as editor-in-chief of Cancer Research on Jan. 1, and his inaugural editorial can be found here.

“Dr. Dang is a prominent and highly regarded physician-scientist, and the American Association for Cancer Research is thrilled to welcome him in his role as editor-in-chief of Cancer Research,” said Margaret Foti, PhD, MD (hc), chief executive officer of the AACR. “His extensive expertise as a cancer scientist and hematologic oncologist and his 20 years of clinical academic leadership experience at preeminent research institutions will further the success and impact of this important journal and accelerate the pace of progress against cancer.”

Cancer Research publishes original studies, reviews, and opinion pieces spanning the spectrum of cancer research. This semi-monthly journal has a stringent peer review process, accepting only those studies that are novel, timely, and of broad significance in the field.

“I am delighted to assume responsibility for this influential journal at a time when cancer research is providing hope that allows us to begin to use the word ‘cure’ without trepidation,” Dang said. “Together with the newly assembled editorial board, I look forward to promoting major scientific findings that embrace innovative research paradigms and team science.”

Dang is a pioneer in biomedical cancer research. His lab was the first to report a link between an oncogene and altered cancer cell metabolism through the discovery that the oncogenic transcription factor MYC plays a pivotal role in the re-programming of fuel utilization in cancer cells, making cancers addicted to certain fuel sources. Research in the Dang laboratory currently focuses on exploiting metabolic vulnerabilities of cancer cells for therapeutic benefit.

Dang received his bachelor’s degree in chemistry from the University of Michigan, Ann Arbor; PhD in chemistry from Georgetown University, Washington, D.C.; and his MD from the Johns Hopkins University School of Medicine, Baltimore. He has published two books, numerous book chapters, and more than 250 scientific articles. Dang is also the recipient of numerous honors. He was appointed to the Blue Ribbon Panel of former Vice President Joe Biden’s National Cancer Moonshot Initiative, is a fellow of the American Academy of Arts and Sciences, a member of the National Academy of Medicine (Institute of Medicine), and chair of the National Cancer Institute’s Board of Scientific Advisors.

Press Release Published Date: 1/11/2018 5:00 AM
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Loftus, EileenThu, 11 Jan 2018 10:08:04
Female Night Shift Workers May Have Increased Risk of Common Cancershttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1139

​PHILADELPHIA — Night shift work was associated with women having an increased risk of breast, skin, and gastrointestinal cancer, according to a meta-analysis published in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research.

“By systematically integrating a multitude of previous data, we found that night shift work was positively associated with several common cancers in women,” said Xuelei Ma, PhD, oncologist at State Key Laboratory of Biotherapy and Cancer Center, West China Medical Center of Sichuan University, Chengdu, China. “The results of this research suggest the need for health protection programs for long-term female night shift workers.”

Ma explained that because breast cancer is the most diagnosed cancer among women worldwide, most previous meta-analyses have focused on understanding the association between female night shift workers and breast cancer risk, but the conclusions have been inconsistent. To build upon previous studies, Ma and colleagues analyzed whether long-term night shift work in women was associated with risk for nearly a dozen types of cancer.

Ma and colleagues performed a meta-analysis using data from 61 articles comprising 114,628 cancer cases and 3,909,152 participants from North America, Europe, Australia, and Asia. The articles consisted of 26 cohort studies, 24 case-control studies, and 11 nested case-control studies. These studies were analyzed for an association between long-term night shift work and risk of 11 types of cancer. A further analysis was conducted, which looked specifically at long-term night shift work and risk of six types of cancer among female nurses.

Overall, long-term night shift work among women increased the risk of cancer by 19 percent. When analyzing specific cancers, the researchers found that this population had an increased risk of skin (41 percent), breast (32 percent), and gastrointestinal cancer (18 percent) compared with women who did not perform long-term night shift work. After stratifying the participants by location, Ma found that an increased risk of breast cancer was only found among female night shift workers in North America and Europe.

“We were surprised to see the association between night shift work and breast cancer risk only among women in North America and Europe,” said Ma. “It is possible that women in these locations have higher sex hormone levels, which have been positively associated with hormone-related cancers such as breast cancer.”

Among female nurses alone, those who worked the night shift had an increased risk of breast (58 percent), gastrointestinal (35 percent), and lung cancer (28 percent) compared with those that did not work night shifts. Of all the occupations analyzed, nurses had the highest risk of developing breast cancer if they worked the night shift.

“Nurses that worked the night shift were of a medical background and may have been more likely to undergo screening examinations,” noted Ma. “Another possible explanation for the increased cancer risk in this population may relate to the job requirements of night shift nursing, such as more intensive shifts.”

The researchers also performed a dose-response meta-analysis among breast cancer studies that involved three or more levels of exposure. They found that the risk of breast cancer increased by 3.3 percent for every five years of night shift work.

“Our study indicates that night shift work serves as a risk factor for common cancers in women,” said Ma. “These results might help establish and implement effective measures to protect female night shifters. Long-term night shift workers should have regular physical examinations and cancer screenings.

“Given the expanding prevalence of shift work worldwide and the heavy public burden of cancers, we initiated this study to draw public attention to this issue so that more large cohort studies will be conducted to confirm these associations,” he added.

A limitation of this work is a lack of consistency between studies regarding the definition of “long-term” night shift work, with definitions including “working during the night” and “working at least three nights per month.” Additional limitations include significant between-study heterogeneity and publication bias.

Ma declares no conflict of interest.

Press Release Published Date: 1/7/2018 7:05 PM
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Loftus, EileenFri, 5 Jan 2018 05:09:10
Mutational Signatures May Identify Patients with Breast Cancer Most Likely to Benefit from Platinum-based Chemotherapyhttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1138

PHILADELPHIA — The presence in advanced breast cancer of mutational signatures characteristic of homologous recombination deficiency (HRD) was associated with improved clinical outcomes to treatment with platinum-based chemotherapy, according to results published in Clinical Cancer Research, a journal of the American Association for Cancer Research.

“Many patients with breast cancer, especially those with the difficult-to-treat triple-negative subtype, are treated with platinum-based chemotherapies like cisplatin, but not all have responses to this treatment,” said Steven J.M. Jones, PhD, head of bioinformatics and codirector of Canada’s Michael Smith Genome Sciences Centre at BC Cancer in Vancouver, British Columbia. “If we could better identify those who are likely to respond to platinum-based chemotherapy, we could optimize patient treatment.

“We found that whole-genome sequencing of breast cancers can reveal mutational patterns characteristic of HRD that identify patients who are likely to respond well to platinum-based chemotherapies,” added Jones. “As whole-genome sequencing becomes more affordable, this presents an opportunity to improve breast cancer treatment.”

Homologous recombination is one of several cellular mechanisms by which normal cells repair damaged DNA. Deficiencies in this pathway occur in many cancers, including the 5 to 10 percent of breast cancers with hereditary BRCA1 and BRCA2 mutations. In cells that are deficient in homologous recombination, the DNA develops signature mutational patterns, said Jones.

Because it is known that platinum-based chemotherapy is particularly effective for patients with BRCA1 or BRCA2 mutations, Jones; Eric Y. Zhao, a graduate student in Jones’ laboratory; and colleagues set out to determine whether genomic mutational patterns characteristic of HRD, which are found in as many as 20 to 40 percent of breast cancers, may also be associated with good responses to platinum-based chemotherapy.

The researchers performed whole-genome sequencing on tumor tissue and matched normal tissue from 93 patients with breast cancer, 33 of whom had been treated with a platinum-based chemotherapy. After analyzing the data for the presence of six HRD-associated mutational signatures, they used a mathematical model called HRDetect, previously shown to predict BRCA1 and BRCA2 deficiency, to calculate an HRDetect score for each breast cancer. Nineteen breast cancers had high HRDetect scores (greater than0.7), 37 had moderate scores (0.005–0.7), and 37 had low scores (less than 0.005).

“Importantly, all seven cancers with pathogenic BRCA1 or BRCA2 mutations had high HRDetect scores,” said Jones. “Thus, our study validated HRDetect using an independent cohort, which is important because whole-genome sequencing protocols can be variable across institutions.”

Further analysis showed that after adjusting for BRCA1/2 mutation status, high HRDetect scores were significantly associated with clinical improvement, as assessed by radiographic tumor shrinkage, following platinum-based chemotherapy. Among the 26 patients who had been treated with a platinum-based chemotherapy and for whom imaging data were available, clinical improvement was observed for eight of the 11 patients whose breast cancers had high HRDetect scores but only two of the 15 patients whose breast cancers had moderate or low HRDetect scores. Three of the eight patients with high HRDetect scores who had clinical improvement had known or likely pathogenic BRCA1 or BRCA2 mutations.

The median total duration on platinum-based chemotherapy and median overall survival was 3 months and 1.3 years longer, respectively, for those with high HRDetect scores compared with those with low HRDetect scores. However, the authors cautioned that these results should be interpreted carefully as they were calculated based on data from a small number of patients.

According to Jones, the main limitation of the study is that it was observational, meaning that the researchers examined a patient cohort for a clinically meaningful correlation, and that it, therefore, does not establish causation. He explained that establishing causation would require a randomized controlled trial but that the findings of their study will likely be helpful in the design of such a trial.

This study was supported by funds from the BC Cancer Foundation. Contributions toward equipment and infrastructure came from the Canada Foundation for Innovation and the BC Knowledge Development Fund. Jones declares no conflicts of interest.

Press Release Published Date: 12/18/2017 10:45 AM
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Beveridge, MichaelMon, 18 Dec 2017 03:36:32
First-in-class ERK1/2 Inhibitor Safe, Shows Early Efficacy in Patients With Advanced Solid Tumors http://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1137

​PHILADELPHIA — The novel ERK1/2 kinase inhibitor ulixertinib displayed an acceptable safety profile and had clinical activity in patients whose tumors had mutations in the MAPK cell-signaling pathway, according to data from a phase I clinical trial published in Cancer Discovery, a journal of the American Association for Cancer Research.

“A great number of cancers, including melanoma and lung cancers, have mutations in the MAPK/ERK pathway, and while current therapies target proteins in this cascade, many patients develop resistance to current drugs,” said Ryan J. Sullivan, MD, assistant professor of hematology and oncology and member of the Termeer Center for Targeted Therapies at Massachusetts General Hospital. “The common denominator in these failed therapies is that the cancer has found a way to activate ERK. Therefore, the development of ERK inhibitors is a crucial next step to target this aberrant pathway.”

The MAPK/ERK pathway is essential for key cellular processes, and mutations along this pathway may result in uncontrolled cellular growth, which can lead to cancer. The RAS gene, an upstream regulator within the MAPK/ERK cascade, is mutated in roughly 30 percent of human cancers. Mutations in BRAF, another gene in this pathway, often occur at codon V600 in malignant melanoma, where combined BRAF/MEK inhibition is the current standard of care. Atypical BRAF mutations (non-V600) are found in a variety of cancers. There is no targeted therapy for patients with atypical BRAF-mutant cancers, said Sullivan.

The ERK gene is the final regulator in the MAPK/ERK pathway, and when upstream inhibition of this protein cascade fails, ERK signaling is reactivated, resulting in renewed MAPK signaling, Sullivan explained. “Targeting ERK for inhibition may allow the opportunity to thwart resistance from upstream mechanisms,” he noted. Preclinical studies had shown ERK inhibition to overcome resistance to BRAF and MEK inhibitors.

Sullivan and colleagues tested the ERK inhibitor ulixertinib in an open-label, first-in-human study. They enrolled 27 patients in the dose-escalation phase and 108 in the dose-expansion phase. All patients had advanced solid tumors, and more than 65 percent had BRAF-mutant cancers. Of the patients, 24 percent had received prior BRAF and/or MEK therapy and 51 percent had received prior immunotherapy. 

In the dose-escalation phase, the recommended phase II dose (RP2D) of ulixertinib was determined to be 600mg twice daily. The dose-expansion portion of the trial tested the RP2D of ulixertinib in six groups of patients whose tumors had BRAF, NRAS, or MEK mutations, the majority of whom were not treated with prior MAPK-targeted therapy. Partial responses (PR) were seen in 12 percent and 14 percent of evaluable patients in the dose-escalation and dose-expansion cohorts, respectively. PR and/or disease stabilization was seen in all groups, including solid tumors with atypical BRAF mutations.

“It was exciting to see responses in some patients, especially those with non-V600 BRAF mutations,” said Sullivan. “We also saw responses in some patients with BRAF V600 mutant melanoma who had progressed on prior BRAF/MEK inhibitor therapy. ERK inhibition may be a potential way forward for these populations.”

Patients treated at the RP2D had near-complete inhibition of ERK as verified in blood samples. Side effects were comparable to other MAPK inhibitors, and the most common treatment-related adverse event (AE) was rash. No AEs above grade 3 were observed.

“This study shows that ulixertinib is tolerable and has activity in a subset of patients with mutations in the MAPK pathway,” said Sullivan. “The results of this study can be built upon to develop better treatment regimens for these patients.”

Sullivan anticipates that ERK inhibitors will likely be used in combinatorial therapies, and they may supplement pre-existing regimens, such as BRAF/MEK inhibition. “I think we’ll see very complex combinations tailored to specific cancer subtypes, and ERK inhibitors deserve to be part of the repertoire,” Sullivan said.

Based on data from this trial, ulixertinib has received the U.S. Food and Drug Administration’s Fast Track designation.

Limitations of the study include a small pool of expansion cohorts, as is consistent with a phase I trial, and lack of tumor pharmacodynamic analysis.

This study was sponsored by BioMed Valley Discoveries, in which several authors are or were employed. Sullivan declares no potential conflicts of interest.

Press Release Published Date: 12/14/2017 7:05 PM
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Loftus, EileenThu, 14 Dec 2017 04:07:52
Oral Microbiota Indicates Link Between Periodontal Disease and Esophageal Cancerhttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1136

​PHILADELPHIA — An analysis of bacteria present in the mouth showed that some types of bacteria that lead to periodontal disease were associated with higher risk of esophageal cancer, according to a study published in Cancer Research, a journal of the American Association for Cancer Research.  

Esophageal cancer is the eighth most common cancer and the sixth leading cause of cancer death worldwide, said the study's lead author, Jiyoung Ahn, PhD, an associate professor and associate director for population science at the Laura and Isaac Perlmutter Center at NYU Langone Health in New York. Because the disease is often not discovered until it has reached an advanced stage, five-year survival rates range from about 15 to 25 percent worldwide.

"Esophageal cancer is a highly fatal cancer, and there is an urgent need for new avenues of prevention, risk stratification, and early detection," Ahn said.

Previous research has shown that periodontal disease caused by certain oral microbiota has been associated with several types of cancer, including oral and head and neck cancers.

In order to determine whether oral microbiota were associated with subsequent risk of esophageal adenocarcinoma (EAC) or esophageal squamous cell carcinoma (ESCC), Ahn and colleagues collected oral wash samples from 122,000 participants in two large health studies: the National Cancer Institute Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial and the American Cancer Society Cancer Prevention Study II Nutrition cohort. 

In 10 years of follow-up, 106 participants developed esophageal cancer. In a prospective case-control study, the researchers extracted DNA and sequenced oral wash samples, allowing researchers to compare the oral microbiomes of the esophageal cancer cases and the cancer-free cases.

Certain bacteria types were associated with higher risk of esophageal cancer. For example, higher levels of the Tannerella forsythia bacteria were associated with a 21 percent increased risk of EAC. The bacteria Porphyromonas gingivalis was associated with a higher risk of ESCC. Both species of bacteria are linked with common gum disease, Ahn noted.

The study showed that a few types of oral bacteria were associated with lower risk of esophageal cancer. For example, the Neisseria bacteria was associated with lower risk of EAC. Ahn said this indicates that certain bacteria may have a protective effect, and future research could potentially examine whether these bacteria could play a role in preventing esophageal cancer.

"Our study indicates that learning more about the role of oral microbiota may potentially lead to strategies to prevent esophageal cancer, or at least to identify it at earlier stages," Ahn said. "The next step is to verify whether these bacteria could be used as predictive biomarkers."

Ahn added that the study confirms that good oral health, including regular tooth brushing and dental visits, is an important way to guard against periodontal disease and the growing list of health conditions associated with it.

The study's primary limitation is that the researchers did not have complete information on the participants' oral health. Therefore, they could not determine whether the presence of pathogens was enough to affect esophageal cancer risk, or whether full-blown periodontal disease was the risk factor.

The study was funded by the National Cancer Institute. The Cancer Prevention Study II is funded by the American Cancer Society. Ahn declares no conflicts of interest.

Press Release Published Date: 12/10/2017 7:05 PM
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Loftus, EileenMon, 11 Dec 2017 03:01:34
Lymph Node Surgery May Raise Risk of Arm Morbidity in Younger Womenhttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1135

​SAN ANTONIO — Younger breast cancer patients who underwent axillary lymph node dissection were more likely to experience arm swelling and decreased range of arm motion than patients who received sentinel lymph node biopsies, according to data presented at the 2017 San Antonio Breast Cancer Symposium, held Dec. 5–9.

“Breast cancer is the most common form of cancer in women under the age of 40, but younger breast cancer patients are frequently underrepresented in clinical trials,” said the study’s lead author, Anne Kuijer, PhD, a postdoctoral research fellow at Dana-Farber Cancer Institute/Brigham and Women’s Hospital, and a surgical resident at Diakonessen Hospital Utrecht, Netherlands. “As a result, little is known about optimal treatment strategies and comorbidities, such as arm swelling and decreased range of motion, in younger patients.

“These issues are of particular importance in these patients given their long survivorship period, frequently active lifestyle, and the importance of body image,” Kuijer added.

Many breast cancer patients undergo axillary surgery to determine whether the breast cancer has spread to nearby lymph nodes. Traditionally, women with involved lymph nodes have undergone a more extensive axillary lymph node dissection (ALND). In recent years, studies have shown that the less invasive sentinel lymph node biopsy (SLNB) procedure is safe in selected breast cancer patients with no or limited nodal involvement upon diagnosis.

To assess the incidence of arm morbidity associated with ALND and SLNB, Kuijer and colleagues examined reports from 1,302 women aged 40 or younger who were enrolled in the Young Women’s Breast Cancer Study, a multicenter prospective cohort study that was established to explore biological, medical, and psychosocial issues in young breast cancer patients. Fifty-five percent of the women had undergone an SLNB only, and 41 percent had undergone ALND. In the remaining 4 percent of patients, no axillary surgery was performed. 

Kuijer and colleagues examined the incidence of patient-reported arm swelling or decreased range of motion one year after diagnosis, using criteria from the Cancer Rehabilitation Evaluation System, or CARES-SF. Overall, 13 percent of the women reported arm swelling and 40 percent reported decreased range of motion in the ipsilateral arm—the arm on the same side as the breast tumor—one year after breast cancer diagnosis.

In patients who were treated with breast conserving surgery, the incidence of arm-swelling one year after diagnosis was 6 percent in patients who underwent SLNB and 24 percent in patients who received ALND. For patients who underwent unilateral or bilateral mastectomy, the incidence of arm-swelling was 6 percent and 23 percent for patients who received SLNB or ALND, respectively.

Kuijer said she was surprised by the high rates of self-reported decreased range of motion in the ipsilateral arm one year after diagnosis; 32 percent and 36 percent in patients who received breast conserving surgery combined with a SLNB or ALND respectively, and 28 percent and 44 percent in patients who underwent unilateral or bilateral mastectomy with SLNB or ALND.

Kuijer said the study highlights the importance of de-escalating axillary treatment when appropriate in young breast cancer patients, and illustrates that even conservative surgery has long-lasting effects. “Women should be encouraged to talk to their doctors about all of their options for surgery and the expected outcomes,” Kuijer said.

Kuijer noted that certain patient factors were associated with greater risk of arm morbidity. Being overweight at the time of diagnosis increased the risk for arm-swelling and decreased range of motion. “This is not something patients can influence right away at the time of diagnosis, but it highlights the overall importance of an active and healthy lifestyle,” Kuijer said.

Financial status also played a part; women who described themselves as financially comfortable were less likely to develop arm-swelling. “This highlights the importance of ensuring adequate social support and resources for young patients undergoing breast cancer treatment,” Kuijer added.

Kuijer noted that this study cohort included women who had been treated at some of the largest cancer centers in the Northeast. The study participants may have been of higher socioeconomic status and may have led more active lifestyles than the general population; if so, the incidence of arm morbidity in the general population may be higher. Also, Kuijer said, the study used patient-reported outcomes rather than an objective measure of arm morbidity.

This study was funded by the National Institutes of Health, the Susan G. Komen Foundation, The Pink Agenda, and the Breast Cancer Research Foundation. Kuijer and her colleagues declare no conflicts of interest.

Press Release Published Date: 12/8/2017 5:30 AM
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Loftus, EileenFri, 8 Dec 2017 10:49:47
Older Women with HR-positive Breast Cancer May Receive Similar Benefit from CDK 4/6 Inhibitors as Younger Womenhttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1131

​SAN ANTONIO — Older women with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer who were treated with cyclin-dependent kinase inhibitors 4 and 6 (CDK4/6) achieved progression-free survival at a rate similar to that of younger women, according to data presented at the 2017 San Antonio Breast Cancer Symposium, held Dec. 5–9.

In the past two years, the U.S. Food and Drug Administration (FDA) has approved three CDK4/6 inhibitors: palbociclib (Ibrance), ribociclib (Kisqali), and abemaciclib (Verzenio). The drugs work by blocking the function of proteins CDK4 and CDK6, both of which drive cell multiplication, fueling tumor growth. Previous research has shown that for patients with HR-positive metastatic breast cancer, combining a CDK4/6 inhibitor with endocrine therapy improves progression-free survival (PFS) compared to endocrine therapy alone.

“As we approve new drugs to treat cancer, it is important to try to improve our understanding of the efficacy and safety of these drugs in our older patients,” said the study’s lead author, Harpreet Singh, MD, scientific liaison for Cancer in Older Adults and a medical officer in the Office of Hematology and Oncology Products, Center for Drug Evaluation and Research at the FDA. “Older patients traditionally have been underrepresented in oncology clinical trials, so pooling outcomes of older patients across clinical trials in the same drug class allows us to gain insight into how these patients may benefit.”

In this study, Singh and colleagues pooled and analyzed data from prospective, randomized studies of three different CDK4/6 inhibitors in combination with an aromatase inhibitor for the initial treatment of postmenopausal patients with HR-positive metastatic breast cancer. Using Kaplan-Meier estimates and a Cox-proportional hazard model, they explored the effect of age on progression-free survival.

Of 1,334 total patients, 42 percent were 65 or older, and 24 percent were 70 or older. For patients 70 or older who were treated with a CDK4/6 inhibitor in combination with an aromatase inhibitor, the estimated PFS was not reached, compared with an estimated PFS of 18 months for those treated only with an aromatase inhibitor.

For patients under 70 treated with a CDK4/6 inhibitor, the estimated PFS was 23.5 months, compared with an estimated 13.8 months for those treated only with an aromatase inhibitor. 

The researchers also evaluated safety in the patients who had taken at least one dose of CDK4/6 inhibitor. The study showed that the older patients were more likely than the younger patients to discontinue treatment due to side effects: 20 percent of the patients 70 or older discontinued treatment, compared with 17 percent of the patients 65 or older and 8 percent of the patients under age 65. Singh said the most common events that led to discontinuation of treatment across all age groups were infection, fatigue, blood count abnormalities (neutropenia), liver enzyme abnormalities, and diarrhea.

“Our findings suggest that there is no treatment difference across age subgroups in terms of efficacy of CDK4/6 inhibitors,” Singh said. “This is an important piece of information as health care providers and patients weigh their treatment options as new therapies are approved.”

Coauthor Lynn Howie, MD, a medical officer in the same division of the FDA, added that the potential benefit for older breast cancer patients should be weighed against risk of toxicity. In addition to the higher rates of discontinuation of treatment, older patients often required more modification of dosages to help them manage side effects.

“Health care providers should counsel each patient individually on the potential benefit of these therapies as well as the potential risks, taking into account the patient’s disease characteristics, performance status, comorbidities, social support, and treatment preferences,” Howie said.

The authors added that as the population ages, the FDA and other stakeholders are exploring ways to increase the representation of older patients in clinical trials to gain more information on how to treat older adults with cancer.

The study’s primary limitation is the relatively small numbers of older patients enrolled in the clinical trials, particularly those over 75. Singh noted that many older adults who enroll in clinical trials are healthier than their peers, with fewer comorbidities and less frailty, so their results may not be representative of the broader population.

The study was run by the FDA, and the authors have no conflicts of interest.

Press Release Published Date: 12/8/2017 3:30 AM
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Loftus, EileenThu, 7 Dec 2017 04:05:11
Postmenopausal Women Who Lose Weight May Have Reduced Breast Cancer Riskhttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1132

​SAN ANTONIO — Postmenopausal women who lose weight may have a significantly reduced chance of developing breast cancer, according to data presented at the 2017 San Antonio Breast Cancer Symposium, held Dec. 5–9.

“Breast cancer is among the leading types of cancer and causes of death in American women,” said Rowan Chlebowski, MD, PhD, research professor in the Department of Medical Oncology and Therapeutics Research at City of Hope in Duarte, California. “Obesity rates have been increasing in the United States. We wanted to determine if there was a link between obesity and breast cancer risk.”

Several studies have associated high body mass index (BMI) with increased breast cancer risk, noted Chlebowski. While this risk factor is largely preventable, it is estimated that more than 65 percent of American women are overweight or obese.

“We wanted to determine if weight loss was associated with lower breast cancer incidence, as studies have not been able to consistently show that losing weight reduces the risk of breast cancer,” said Chlebowski. Past studies have been limited to analyses with self-reported measurements, while the prospective study conducted by Chlebowski and colleagues utilizes a short-term, three-year period of measured body weight and height followed by a long period of follow-up.

Chlebowski and colleagues analyzed data from the Women’s Health Initiative (WHI) Observational Study. This program tracks the health of postmenopausal women between the ages of 50 and 79. Participants who had a normal mammogram, no prior breast cancer, and were not underweight (BMI ≥ 18.5) were eligible for enrollment in Chlebowski’s study. Measurements for height and weight were obtained upon enrollment, and measurements were reassessed three years following.

At baseline, 41 percent of women were normal weight, 34 percent were overweight, and 25 percent were obese.

Of the 61,335 patients enrolled in Chlebowski’s study, 3,061 developed invasive breast cancer during an average of 11.4 years of follow-up. Compared to women with stable weight, those who lost weight (≥ 5 percent weight change) were 12 percent less likely to develop breast cancer following multivariable analysis. Weight loss of ≥ 15 percent was associated with a 37 percent reduction in breast cancer risk.  

“In the three-year window of the study, relatively modest weight loss was associated with significant lowering of breast cancer incidence,” said Chlebowski. “From this study, we have evidence that a weight loss strategy can be effective in lowering breast cancer risk in postmenopausal women.”

While weight gain (≥ 5 percent weight change) was not associated with increased overall breast cancer risk, it was associated with more than 50 percent increased risk of triple-negative breast cancer.

The study was supported by the National Institutes of Health (NIH). Chlebowski is a consultant for Novartis, Astra Zeneca, Genentech, and Amgen.

Press Release Published Date: 12/8/2017 3:30 AM
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Loftus, EileenThu, 7 Dec 2017 04:10:30
Circulating Tumor Cells May Predict Late Recurrence in HR-positive Breast Cancer Patientshttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1133

SAN ANTONIO —Among patients with hormone receptor (HR)-positive HER2-negative stage 2-3 breast cancer without clinical evidence of recurrence, those who had circulating tumor cells (CTC) detected in blood five years after diagnosis had an increased risk for late recurrence of breast cancer, according to data presented at the 2017 San Antonio Breast Cancer Symposium, held Dec. 5–9.

“We found that a single positive CTC assay result five years after diagnosis provides independent prognostic information for late recurrence,” said Joseph A. Sparano, MD, associate director for clinical research, Montefiore Einstein Center for Cancer Care, Albert Einstein Cancer Center, New York. “This provides proof of concept that liquid biopsy-based biomarkers may be used to stratify risk for late recurrence and possibly inform treatment or clinical trial options.”

Despite advances in breast cancer treatment in recent years, many women still have late-recurrent disease five years or more after the initial diagnosis. HR-positive breast cancers, which make up more than half of all breast cancer cases, have an increased risk of late recurrence, noted Sparano. “Biomarkers for late recurrence that may help guide therapy are needed,” he stressed.

Participants of the study, designed and conducted by Sparano and colleagues in the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), were previously enrolled in ECOG-ACRIN clinical trail E5103, which assessed the addition of bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, to chemotherapy as adjuvant treatment following surgery. Sparano and colleagues measured CTCs in blood samples from patients using the CELLSEARCH CTC assay between 4.5 and 7.5 years after an initial diagnosis of HER2-negative stage 2-3 breast cancer. No patients had clinical evidence of recurrence at the time of enrollment. Of patients with HR-positive breast cancer, 4.5 percent had recurrence of the disease; this compares to a recurrence rate of 0.5 percent in the HR-negative group.

Of the 546 patients enrolled in the study, 4.8 percent had a positive CTC assay result. Among patients with HR-positive breast cancer, 5.1 percent had a positive CTC result; among those with HR-negative disease, 4.3 percent had a positive CTC result. After a median follow-up of 1.6 years, a positive CTC assay result was associated with a nearly 20-fold increased risk of breast cancer recurrence in patients with HR-positive disease. The positive predictive value of a positive CTC assay for recurrence by two years in patients with HR-positive disease was 35 percent, and the negative predictive value for patients in this cohort was 98 percent. A positive CTC assay was not associated with recurrence in the HR-negative group.

Sparano commented that these results were somewhat unexpected. “We were surprised to see that 5 percent of patients had CTCs about five or more years after their initial diagnosis,” he said. “Although we were expecting that CTC-positive patients would have a higher recurrence rate, we weren’t expecting the risk of recurrence to be this high after a relatively short period of time.

“This study provides strong evidence of the clinical validity of the CTC assay as a prognostic biomarker for late recurrence in HR-positive breast cancer, which accounts for about one-half of all recurrences,” Sparano said. “Utilizing the CTC assay for prognostic analysis may aid in a more accurate identification of patients who would most benefit from extended adjuvant endocrine therapy or other treatment options,” he noted.

Next steps include studying how a single negative CTC test or serial negative tests could serve as a negative predictive marker that may allow sparing of extended adjuvant endocrine therapy beyond five or more years.

Limitations of the study include short follow-up after the CTC assay, with an average time of 1.6 years. Sparano noted that additional follow-up is required, and that further study will be necessary to determine the clinical utility of the CTC assay in this setting.

ECOG-ACRIN received funding for this study from the Breast Cancer Research Foundation, Susan G. Komen, and the National Cancer Institute. Sparano declares no conflicts of interest.

Press Release Published Date: 12/8/2017 3:30 AM
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Loftus, EileenThu, 7 Dec 2017 04:15:50
Phase III EMBRACA Trial Meets Primary Endpointhttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1134

​SAN ANTONIO — Patients with advanced HER2-negative breast cancer with germline BRCA mutations had significantly prolonged progression-free survival (PFS) when treated with the PARP inhibitor talazoparib compared with those who received chemotherapy of physician’s choice, according to data from the phase III trial, EMBRACA, presented at the 2017 San Antonio Breast Cancer Symposium, held Dec. 5–9.

“We are very pleased that the phase III EMBRACA trial—the largest randomized clinical trial conducted in this group of patients with hereditary breast cancer—met its primary efficacy endpoint of progression-free survival,” said Jennifer Litton, MD, associate professor in the Department of Breast Medical Oncology at The University of Texas MD Anderson Cancer Center.

Talazoparib is a dual mechanism PARP inhibitor that inhibits the PARP enzyme and also traps PARP on DNA, thus preventing DNA damage repair, leading to death in BRCA1/2-mutated cells, Litton explained. Prior studies had shown that talazoparib’s unique structural properties make it more effective in trapping PARP-DNA complexes. This therapeutic had yielded promising results in preclinical studies and previous phase I and II clinical trials.

“In EMBRACA, talazoparib demonstrated superior clinical benefit in all subsets of patients, regardless of receptor subtype (HR-positive or triple-negative breast cancer), number of prior lines of chemotherapy, BRCA mutation type and central nervous system metastasis,” noted Litton.

The U.S. Food and Drug Administration has approved three PARP inhibitors so far—olaparib (Lynparza), rucaparib (Rubraca), and niraparib (Zejula)—to treat certain ovarian cancers, including those with BRCA gene mutations.

EMBRACA is an open-label, randomized, phase III trial to compare the efficacy and safety of 1 mg/day talazoparib with standard single-agent physician’s choice of therapy (PCT) (capecitabine, eribulin, gemcitabine, or vinorelbine) in patients with advanced breast cancer and a germline BRCA1/2 mutation. Patients were randomly assigned (2:1) to talazoparib (287) or PCT (144).

The primary objective was PFS, assessed by blinded independent central review, and secondary objectives were overall survival (OS), overall response rate (ORR) and clinical benefit rate at 24 weeks (CBR24), and safety. Patient-reported outcomes were also measured. 

The median PFS was 8.6 months for patients in the talazoparib arm, versus 5.6 months for those in the PCT arm, and this difference was statistically significant. Patients in the talazoparib arm were 45.8 percent less likely to have disease progression, compared with those in the PCT arm.

ORR and CBR24 showed a statistically significant improvement for those in the talazoparib arm compared with those in the PCT arm: The ORR was 62.6 percent for patients in the talazoparib arm, versus 27.2 percent for those in the PCT arm. Twelve complete responses were observed in the study, all in the talazoparib arm. The CBR24 was 68.6 percent for patients in the talazoparib arm, versus 36.1 percent for those in the PCT arm.

An interim analysis of overall survival was also conducted; although data are not yet mature, a positive trend favoring talazoparib was observed, with a 24 percent reduction in the risk of death. Survival data will continue to be monitored and final OS estimates reported once the data matures, Litton said.

Quality-of-life measurements revealed that in the talazoparib arm, patents had a significant delay in the time to deterioration in health compared with patients in the PCT arm, using the EORTC QLQ-C30 questionnaire.

“Most notable for this study was not only the improvement to date of PFS, but the time to clinical deterioration, which was 24.3 months for patients on talazoparib, versus 6.3 months for those on standard-of-care chemotherapy,” Litton noted.

Fifty-five percent of patients in the talazoparib arm experienced grade 3-4 hematologic adverse events, versus 39 percent of those in the PCT arm. Talazoparib was associated with fewer grade 3-4 gastrointestinal disorders and skin/subcutaneous tissue disorders than PCT. Grade 3-4 serious adverse events were observed in 26 percent and 25 percent of patients in talazoparib and PCT arms, respectively. Adverse events resulting in death occurred in 2.1 percent and 3.2 percent of patients in talazoparib and PCT arms, respectively. 

“Overall, once-daily oral talazoparib was well tolerated in comparison to chemotherapy, with improvements in progression-free survival and clinical responses, providing a significant option for patients with BRCA mutations and metastatic breast cancer. We look forward to following the OS results as those data mature,” said Litton.

This study was funded by Pfizer. Litton has research funding with EMD Serono, AstraZeneca, Pfizer, Genentech, and GlaxoSmithKline, and serves on advisory boards for Pfizer and AstraZeneca, all uncompensated.

Press Release Published Date: 12/8/2017 3:30 AM
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Loftus, EileenFri, 8 Dec 2017 08:31:03
Two Years of Extended Anastrozole Therapy Proved as Effective as Five Years in Clinical Trialhttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1123

SAN ANTONIO — Postmenopausal women with hormone-receptor positive (HR-positive) breast cancer who took the aromatase inhibitor anastrozole for two years after an initial five years of adjuvant endocrine therapy received an equal benefit to those who took the drug for five additional years. The trial results suggest that a shorter duration of treatment may provide sufficient benefits while protecting women from harmful side effects, according to data from the ABCSG-16 phase III trial presented at the 2017 San Antonio Breast Cancer Symposium, held Dec. 5–9.

“In early-stage HR-positive breast cancer, the risk of relapse persists despite many advances in treatment,” said Michael Gnant, MD, FACS, director and chairman of the Department of Surgery, Comprehensive Cancer Center, at the Medical University of Vienna. “Adjuvant treatment with aromatase inhibitors has been demonstrated to improve disease-free survival of postmenopausal women with this subtype of breast cancer. However, the optimal duration of extended AI has previously been unknown. Because this treatment leads to prolonged side effects and impacts quality of life, it is important to establish how long the treatment should be given.”

In this trial, between February 2004 and June 2010, 3,484 postmenopausal women with HR-positive early-stage breast cancer were randomized in 71 centers in Austria to receive either two years or five years of extended adjuvant therapy. All had undergone an initial five years of adjuvant endocrine treatment, either tamoxifen or other regimens containing aromatase inhibitors.

The trial’s primary endpoint was disease-free survival. Secondary endpoints included overall survival, contralateral breast cancer (cancer in the opposite breast), fractures, and toxicity.

As of June 30, 2016, 78 percent of women in both trial arms were alive without recurrence; 757 women experienced recurrence, relapse, or other disease-free survival events: 377, or 22 percent, of women in the two-year group and 380, or 22 percent, of women in the five-year group.

There was also no significant difference in overall survival or time to contralateral breast cancer. Bone fractures were more likely in years three to five after randomization, suggesting that a longer duration of anastrozole treatment may be a risk factor for fractures. 

Gnant said the trial results suggest that clinicians should consider a two-year course of anastrozole sufficient for most patients.

“I believe that these trial results should be implemented into daily practice at once,” Gnant said. “There is simply no rationale to keep most patients on extended AI for longer than two years. This result can help save a lot of unnecessary side effects for many women around the world.”

In addition to bone fractures, other side effects of prolonged AI therapy include bone fractures, hot flashes, arthralgia, sexual dysfunction, and hair loss.

Gnant cautioned that researchers cannot rule out benefits for some patients who take anastrozole for longer periods. He said future translational research using data and biomaterial from the patients in the ABCSG-16 trial could be useful to characterize potential molecular factors that influence patients’ response to anastrozole.

The study was funded by AstraZeneca. Gnant has received honoraria, travel or accommodations funding, and research funding from AstraZeneca.

Press Release Published Date: 12/7/2017 3:30 AM
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Loftus, EileenThu, 7 Dec 2017 08:25:43
Phase III Trial Data Support Current Standard 12-month Adjuvant Trastuzumab for HER2-positive Breast Cancerhttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1124

​SAN ANTONIO — Disease-free survival (DFS) after nine weeks of adjuvant trastuzumab and standard chemotherapy was not comparable to DFS after 12 months of adjuvant trastuzumab and standard chemotherapy for women with early-stage HER2-positive breast cancer, supporting the current practice of extended trastuzumab treatment, according to data from the phase III Synergism or Long Duration (SOLD) clinical trial, presented at the 2017 San Antonio Breast Cancer Symposium, held Dec. 5–9.

The study, however, found no substantial difference in the secondary endpoints of distant disease-free survival (DDFS) and overall survival (OS) between the 12-month trastuzumab arm and the nine-week trastuzumab arm.

“The choice for one-year duration of trastuzumab administration in patients with HER2-positive breast cancer was arbitrary, and not based on research data,” said Heikki Joensuu, MD, professor in the Department of Oncology at the Helsinki University Hospital and University of Helsinki in Finland.

In all four large randomized trials that established the current standard treatment (chemotherapy plus trastuzumab), trastuzumab was given for one year and, therefore, the one-year duration became the standard, Joensuu explained. In two randomized trials with relatively limited statistical power, there was no statistical difference in DFS or OS between those who received nine weeks versus 12 months of trastuzumab.

“The current standard treatment is lengthy, costly, and occasionally associated with cardiac adverse events,” Joensuu said. While trastuzumab is well tolerated in general, the most important adverse effect is congestive heart failure (CHF). CHF occurred in less than 3 percent of the patients treated in the pivotal clinical trials, but the risk for trastuzumab-related CHF is likely higher in elderly patients who have pre-existing risk for CHF, he added.

Joensuu and colleagues studied whether it is sufficient to administer trastuzumab with chemotherapy only for a brief period of time (nine weeks) instead of the standard practice of administering trastuzumab both during chemotherapy (for nine weeks) and then as a single agent after stopping chemotherapy (for 12 months).

“We could not demonstrate that the experimental treatment [nine weeks of trastuzumab] is similar in efficacy as the standard treatment [12 months of trastuzumab] in terms of DFS,” said Joensuu. “There was, however, not much difference between the groups in two other important clinical endpoints, DDFS and OS, which were secondary objectives of the study.”

In SOLD, the investigators randomly assigned (1:1) 2,176 patients with early-stage HER2-positive breast cancer to the nine-week trastuzumab arm or the 12-month trastuzumab arm.

Patients in both arms received three cycles of docetaxel (80 mg/m2 or 100 mg/m2) and trastuzumab three times a week, followed by three cycles of chemotherapy. Patients in the nine-week arm received no further treatment while those in the 12-month arm received trastuzumab every three weeks for 14 cycles. Patients with estrogen receptor-positive cancer received appropriate endocrine treatment and radiation therapy per guidelines.

In the 12-month arm, DFS was 90.5 percent, compared with 88 percent in the nine-week arm. There was no substantial difference in DDFS and OS between the two arms: five-year DDFS was 93.2 percent in the nine-week arm and 94.2 percent in the 12-month arm; five-year OS was 94.7 percent in the nine-week arm and 95.9 percent in the 12-month arm.

“Interestingly, we detected a significant interaction between the dose of docetaxel given concomitantly with trastuzumab in preplanned subgroup analyses,” noted Joensuu.

Among patients who received 100 mg/m2 docetaxel, DFS in the nine-week arm was similar to the DFS in the 12-month arm, but among those who received 80 mg/m2 docetaxel, 12 months of trastuzumab yielded superior DFS than nine weeks, suggesting that the dose of docetaxel administered with trastuzumab may influence survival outcomes. “This, and brief dual inhibition of HER2 with trastuzumab and pertuzumab, each given with an adequate dose of a taxane, warrant further studies,” he said.

“The shorter trastuzumab treatment was safer to the heart than the longer treatment,” added Joensuu. Cardiac failure occurred in 3 percent and 2 percent of patients in the 12-month and nine-week arms, respectively. Patients in the nine-week arm had significantly higher cardiac left ventricle ejection fractions (LVEFs) than patients in the 12-month arm, but the absolute differences were small, and the LVEFs mostly returned to the baseline level within three years after the date of randomization, Joensuu said.

A limitation of the study is that because of cancer characteristics and some logistical issues, including not being able to reach the planned number of DFS events within a reasonable time frame, the study had lower statistical power than planned.

SOLD was funded by Pharmac (New Zealand), Sanofi, Novartis, the Academy of Finland, the Cancer Society of Finland, Helsinki University Hospital research funds, Sigrid Juselius Foundation, and Jane and Aatos Erkko Foundation. Joensuu is a scientific advisor for Neutron Therapeutics, has received consultation fees from Orion Pharma, and has stock ownership interest in Orion Pharma, Faron Pharmaceuticals, and Sartar Therapeutics.

Press Release Published Date: 12/7/2017 3:30 AM
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Loftus, EileenThu, 7 Dec 2017 08:30:56
Temporary Ovarian Suppression With Hormone Analog May Preserve Fertility During Breast Cancer Chemotherapy http://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1125

SAN ANTONIO — Meta-analysis of individual patient data from five randomized clinical trials provided a high level of evidence that treatment with a gonadotropin-releasing hormone analog (GnRHa) could safely and effectively protect ovarian function and potentially preserve fertility in premenopausal women receiving chemotherapy for early-stage breast cancer, according to a study presented at the 2017 San Antonio Breast Cancer Symposium, held Dec. 5–9.

“Temporary ovarian suppression obtained by administering GnRHa during chemotherapy is a medical intervention with the potential to preserve ovarian function and fertility in premenopausal breast cancer patients; however, to date, the role of this option remains controversial and it is still considered an experimental technique by the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO),” said Matteo Lambertini, MD, medical oncologist and ESMO fellow at the Institut Jules Bordet in Brussels, Belgium.

The possibility that anticancer treatments will cause premature ovarian insufficiency (POI) and subsequent infertility are prevalent concerns affecting young women diagnosed with breast cancer, which adds significant anxiety and emotional strain as they make treatment decisions, explained Lambertini.

Temporary ovarian suppression with GnRHa during chemotherapy was primarily developed as a strategy to reduce the risk of developing treatment-induced POI than as a fertility-preserving procedure; therefore, the majority of the trials that investigated this strategy had a very short follow-up and did not report on post-treatment pregnancies, Lambertini said. Further, different randomized clinical trials that investigated the efficacy of this approach showed conflicting results, and some of these trials included very few patients, making it difficult to draw solid conclusions based on the results of individual studies, he added.

Lambertini and team aimed to provide more conclusive clinical evidence on this topic by conducting an individual patient data meta-analysis of five randomized clinical trials in which premenopausal women with early-stage breast cancer were randomly assigned to receive chemotherapy alone (437 women) or with concurrent GnRHa (436 women).

The study found that the POI rate in the GnRHa group was 14.1 percent, versus 30.9 percent in the control group; patients in the GnRHa group had 62 percent less risk to develop POI as compared to those treated with chemotherapy alone. Treatment effect was homogeneous among the different patient subgroups.

Patients in the GnRHa group had one- and two-year amenorrhea (absence of menstrual periods) rates of 36.8 percent and 18.2 percent, respectively. One- and two-year amenorrhea rates in the control group were 40.4 percent and 30 percent, respectively.

“Although the absolute numbers remain low, we observed a doubling in the number of post-treatment pregnancies in patients in the GnRHa group compared with those treated with chemotherapy alone. This suggests that GnRHa during chemotherapy is not only a strategy to preserve ovarian function but may also potentially improve future fertility,” Lambertini said.

Thirty-seven patients in the GnRHa group had at least one post-treatment pregnancy during the follow-up period, versus 20 patients in the control group.

There were no significant differences in disease-free survival and overall survival between the two groups; this suggests that administering GnRHa during chemotherapy can be considered safe in breast cancer patients, he said.

“Our study adds important evidence on both the efficacy and the safety of temporary ovarian suppression with GnRHa during chemotherapy, not only in patients with estrogen receptor [ER]-negative disease but also in women with ER-positive tumors, who account for the majority of new cases of breast cancer in young women,” Lambertini commented.

“This study provides solid evidence on this specific topic,” Lambertini said. “We believe that the results of our study would serve as the reference evidence for updating the international ASCO and ESMO guidelines on the use of this strategy.”

The five clinical trials studied were PROMISE-GIM6, POEMS/SWOG S0230, Angelo Celtic Group OPTION, GBG-37 ZORO, and a Moffitt Cancer Center-led trial.

Limitations of the study include the impossibility of including all the randomized clinical trials on this topic, the lack of data on the extent of ovarian function preservation using more sensitive biomarkers, and limited information on patients’ wish to have a pregnancy, according to Lambertini.

This study was partly funded by the Italian Association for Cancer Research. Lambertini does not have any relevant conflicts of interest to disclose.

Press Release Published Date: 12/7/2017 3:30 AM
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Loftus, EileenThu, 7 Dec 2017 08:36:56
Acupuncture Reduced Joint Pain Caused by Aromatase Inhibitor Treatment in a Randomized, Phase III Clinical Trialhttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1126

​SAN ANTONIO — Acupuncture significantly reduced joint pain for postmenopausal women with early-stage breast cancer receiving treatment with an aromatase inhibitor compared with both sham acupuncture and no treatment, according to data from the randomized, phase III SWOG S1200 clinical trial presented at the 2017 San Antonio Breast Cancer Symposium, held Dec. 5–9.

“Aromatase inhibitors are among the most common and most effective treatments for postmenopausal women diagnosed with hormone receptor–positive breast cancer; however, many patients suffer from side effects that cause them to miss treatments or stop treatment altogether,” said Dawn L. Hershman, MD, leader of the Breast Cancer Program at the Herbert Irving Comprehensive Cancer Center at NewYork-Presbyterian/Columbia University Medical Center. “We need to identify strategies to control these side effects, the most common of which is debilitating joint pain and stiffness.

“The data from this randomized, phase III clinical trial indicate that health care practitioners should discuss the possibility of acupuncture with patients experiencing aromatase inhibitor–related joint pain and stiffness because it has the potential to improve their quality of life,” continued Hershman, who is also a vice chair of SWOG, the global cancer clinical trials network funded by the National Cancer Institute (NCI). “We hope that by reducing the debilitating side effects of aromatase inhibitor treatment, acupuncture may improve adherence to treatment and thereby outcomes, but we need to conduct further studies to determine if this is indeed the case.”

Hershman explained that many patients don’t want to take more medications to relieve symptoms caused by aromatase inhibitor treatment. Acupuncture is a traditional Chinese method of medical treatment involving the insertion of fine, single-use, sterile needles in defined acupoints. A number of small, single-institution studies have suggested that it may provide an alternative approach to reducing aromatase inhibitor–related joint pain and stiffness.

Therefore, Hershman and colleagues designed and conducted a multicenter, randomized, blinded trial evaluating whether acupuncture could reduce aromatase inhibitor–related joint symptoms in postmenopausal women diagnosed with early-stage, hormone receptor–positive breast cancer.

The researchers enrolled 226 patients in the trial: 110 were randomized to true acupuncture; 59 to sham acupuncture, which involves superficially inserting needles in nonacupoints; and 57 to waitlist control, which meant no treatment. Patients receiving true acupuncture or sham acupuncture had twice-weekly sessions for six weeks followed by one session per week for six more weeks. Patients reported on their pain before, during, and after treatment using various methods, including the Brief Pain Inventory–Short Form (BPI), a self-administered 14-item questionnaire used to evaluate the severity of a patient's pain on a 0 to 10 scale, where higher scores indicate more pain, and the impact of this pain on the patient's daily functioning.

After six weeks, patients in the true acupuncture treatment arm reported significantly lower BPI worst pain scores compared with those in the sham acupuncture and the waitlist control arms. The mean BPI worst pain for the true acupuncture arm was 0.92 points lower than the mean BPI worst pain for the sham acupuncture arm and 0.96 points lower than the mean BPI worst pain for the waitlist control arm. In addition, the proportion of patients who had a large reduction in BPI worst pain, a reduction of two or more points, was significantly greater in the true acupuncture arm than in the sham acupuncture and the waitlist control arms: 58 percent compared with 33 percent and 31 percent, respectively. The differences remained statistically significant when assessed at 24 weeks, even though the intervention was 12 weeks.

The most common adverse event reported among those receiving true and sham acupuncture was bruising.

“We were very pleased to see acupuncture had durable beneficial effects with no significant side effects in a large, rigorous clinical trial,” said Hershman. “We hope that these data will not only encourage health care practitioners to discuss acupuncture as a complementary therapy for patients receiving aromatase inhibitors, but that they will also enhance payers’ willingness to reimburse these patients for acupuncture.”

This study was supported by grant R01AT006376 from the National Institutes of Health (NIH) National Center for Complementary and Integrative Health and the Office of Research on Women’s Health; and grant UG1CA189974 and legacy grant U10CA37429 from the NIH/NCI/Division of Cancer Prevention. Hershman declares no conflicts of interest.

Press Release Published Date: 12/7/2017 3:30 AM
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Loftus, EileenThu, 7 Dec 2017 08:43:10
Common Genetic Fusion Event May be Associated with Low-risk Prostate Cancerhttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1130

​PHILADELPHIA — Establishing the way in which a genetic alteration called a TMPRSS2-ERG gene fusion forms in a prostate cancer, rather than the presence of the gene fusion itself, could help identify patients with prostate cancer with a low risk of spreading, which might determine the best course of treatment for the patient, according to results published in Cancer Research, a journal of the American Association for Cancer Research.

“Active surveillance is a common approach to caring for patients with a Gleason score of 6, because this score indicates the prostate cancer has a low risk of spreading,” said John C. Cheville, MD, professor of pathology at the Mayo Clinic in Rochester, Minnesota. “Men on active surveillance receive no treatment and are followed. Some of these men are later found to have clinically significant disease that requires treatment.”

A Gleason score provides information on how aggressive a prostate cancer is. It is calculated when a prostate needle biopsy specimen is examined under a microscope. Depending on how normal or abnormal the cancer looks, it is assigned a number from 1 to 5, with 5 being the most abnormal and most aggressive. Different areas of a tumor may have different patterns, and the two highest patterns are added together to give the Gleason score. Most prostate cancers are Gleason score 6 (composed entirely of pattern 3) and men with Gleason score 6 are considered at low risk of having their tumors progress.

“Identifying a biomarker that, in addition to Gleason score, distinguishes men at increased risk for disease progression from those whose prostate cancer never becomes a clinically significant problem could help improve patient care,” said Cheville.

To look for genetic biomarkers of clinically significant or insignificant disease, Cheville and colleagues used whole-genome mate pair sequencing to study gene fusions in prostate cancer tissue samples obtained from 133 patients who underwent a radical prostatectomy at the Mayo Clinic. The prostate cancers were divided into four groups: 53 low volume Gleason 6 tumors were classed as very low risk for progression; 26 high volume Gleason 6 tumors were classed as low risk for progression; 29 Gleason 7 tumors were classed as intermediate risk for progression; and 25 Gleason 8 or higher tumors were classed as high risk for progression.

The researchers detected TMPRSS2-ERG fusions in 45 percent of the prostate cancers analyzed, which is consistent with prior studies, according to Cheville. Fusions were detected in 43 percent, 49 percent, 52 percent, and 24 percent in the very-low risk, low-risk, intermediate-risk, and high-risk groups, respectively.

Among the 60 prostate cancers with TMPRSS2-ERG fusions, 39 had deleted the interstitial genes between TMPRSS2 and ERG during the fusion event and 21 had retained these genes. Eighteen of the 21 prostate cancers that had retained the interstitial genes during TMPRSS2-ERG gene fusion were in the very-low risk and low-risk groups.

“Our data support results from other studies in that the presence or absence of a TMPRSS2-ERG gene fusion was not predictive of outcome,” Cheville said. “But how the gene fusion formed was important; the retention of interstitial genes during the fusion event was more common in very- low risk and low-risk cancers, and there may be genes in this region that suppress or limit tumor growth. There is potential utility for determining the status of interstitial genes in stratifying men with prostate cancer into more well-defined risk groups, but this will require further study before it can be incorporated into clinical practice.”

Information on whether a patient went on to have a biochemical recurrence was available for 34 patients who had prostate cancer with a TMPRSS2-ERG gene fusion with interstitial gene deletion and 22 patients who had prostate cancer with a TMPRSS2-ERG gene fusion with interstitial gene retention. In univariate, but not multivariate, analysis, biochemical recurrence was significantly lower if the prostate cancer had a TMPRSS2-ERG gene fusion with interstitial gene retention compared with those that had interstitial gene deletion.

“The loss or retention of interstitial genes was tied closely to Gleason score, and we did not have enough cases to determine whether or not the type of fusion was an independent marker for biochemical recurrence,” said Cheville. “We need to look at many more samples and also look at patients with higher Gleason scores to determine the extent to which loss of interstitial genes is associated with disease progression.”

According to Cheville, the main limitation of the study is the relatively small number of patients analyzed in each group.

This study was supported by James and Dorothy Nelson Benefactor Funds and the Mayo Clinic Center for Individualized Medicine. Cheville declares no conflicts of interest.

Press Release Published Date: 12/6/2017 7:05 PM
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Loftus, EileenThu, 7 Dec 2017 11:53:08
Ribociclib Improved Progression-free Survival for Pre- and Perimenopausal Women With Hormone Receptor–positive Advanced Breast Cancerhttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1120

​SAN ANTONIO — Adding the CDK4/6 inhibitor ribociclib (Kisqali) to standard endocrine therapy with temporary ovarian suppression significantly improved progression-free survival for pre- and perimenopausal women with advanced hormone receptor–positive (HR-positive), HER2-negative breast cancer, according to data from the MONALEESA-7 phase III clinical trial presented at the 2017 San Antonio Breast Cancer Symposium, held Dec. 5–9.

“Three anticancer therapeutics that target cell-cycle mediators CDK4 and CDK6, so-called CDK4/6 inhibitors, have been approved by the U.S. Food and Drug Administration for use in combination with hormonal drugs, either aromatase inhibitors or fulvestrant, for treating postmenopausal women with HR-positive, HER2-negative advanced breast cancer,” said Debu Tripathy, MD, professor of medicine and chair of the Department of Breast Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston. “These new therapeutics have not yet been evaluated in a dedicated large, randomized trial as a potential treatment for the 30 to 40 percent of women with HR-positive, HER2-negative advanced breast cancer who are pre- or perimenopausal.

“MONALEESA-7 is the first clinical trial to have the statistical power to show that ribociclib has clinical benefit specifically for pre- and perimenopausal women with HR-positive, HER2-negative advanced breast cancer,” continued Tripathy. “It is also the first trial to show that ribociclib can be safely and effectively combined with either tamoxifen or a nonsteroidal aromatase inhibitor together with ovarian suppression using goserelin.”

Among the 672 patients enrolled in the clinical trial by Tripathy and colleagues, 335 were randomized to ribociclib in combination with either tamoxifen or a nonsteroidal aromatase inhibitor (letrozole or anastrozole) and goserelin, and 337 were randomized to placebo in combination with the same oral hormonal therapy options and goserelin. The primary endpoint of the trial was progression-free survival.

The study met its primary endpoint: Progression-free survival was significantly improved in the ribociclib arm compared with the placebo arm. Median progression-free survival was 23.8 months in the ribociclib arm compared with 13.0 months in the placebo arm.

Data are available for some of the secondary endpoints. For example, the overall response rate, which is the percentage of patients who had a partial or a complete response, was significantly higher among patients with measurable disease at baseline in the ribociclib arm compared with the placebo arm (51 percent versus 36 percent).

As expected, the most frequent adverse event was neutropenia, which was reported in 76 percent of patients in the ribociclib arm compared with 8 percent in the placebo arm. Grade 3/4 neutropenia was reported in 61 percent of patients in the ribociclib arm compared with 4 percent in the placebo arm, but it was asymptomatic in most patients; neutropenia associated with fever and infection was reported in 2 percent of patients in the ribociclib arm and 1 percent in the placebo arm. Other adverse events included hot flashes, nausea, leukopenia, and joint pain/stiffness. Adverse events leading to permanent discontinuation of treatment occurred in 4 percent of patients in the ribociclib arm compared with 3 percent in the placebo arm.

“Longer follow-up is needed to determine whether the trial will meet its secondary endpoint of overall survival,” said Tripathy. “However, these initial results are very exciting because the World Health Organization reports that breast cancer is the leading cause of cancer-related death among women aged 20–59 years worldwide.”

This study was supported by funds from Novartis. Tripathy serves as a paid consultant for Novartis. The University of Texas MD Anderson Cancer Center received funds from Novartis to conduct this study.

Press Release Published Date: 12/6/2017 8:20 AM
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Loftus, EileenTue, 5 Dec 2017 04:41:15
Immunotherapy Shows Early Promise for Patients With Trastuzumab-resistant Breast Cancer http://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1121

SAN ANTONIO —A combination of pembrolizumab (Keytruda) and trastuzumab, tested in patients with trastuzumab-resistant advanced HER2-positive breast cancer, was well tolerated and had clinical benefit in patients whose tumors were positive for a biomarker for pembrolizumab, according to data presented from the phase Ib/II PANACEA trial at the 2017 San Antonio Breast Cancer Symposium, held Dec. 5–9.

“We wanted to investigate if immunotherapy approaches can work in patients with advanced HER2-positive breast cancer that is resistant to trastuzumab,” said Sherene Loi, MD, PhD, associate professor at Peter MacCallum Cancer Centre in Melbourne, Australia, working with the International Breast Cancer Study Group (IBCSG).

It is estimated that approximately 20 percent of invasive breast cancers are HER2-positive, and some of these patients develop resistance to trastuzumab, a HER2-specific monoclonal antibody utilized for treatment of the disease. Loi and colleagues hypothesized that immunotherapy may help to overcome trastuzumab resistance in this subset of breast cancers.

“We believe that immune evasion is a part of the biological resistance to trastuzumab in patients with this disease,” commented Loi. “Prior studies from our group have shown that antitumor immunity is important for improved outcomes in patients with advanced HER2-positive breast cancer.” Loi and colleagues previously demonstrated that patients with trastuzumab-resistant advanced HER2-positive breast cancer had evidence of poor immune responses, and preclinical studies revealed that anti-PD1 immunotherapy improved the therapeutic activity of trastuzumab. 

In this phase Ib/II clinical trial, Loi and colleagues enrolled 58 patients with advanced breast cancer that had progressed on prior trastuzumab-based therapies. Tumors were assessed centrally for HER2 positivity and PDL1 status, and for quantity of tumor-infiltrating lymphocytes (TILs).

The Phase Ib portion of the trial was a dose-escalation study of pembrolizumab, an anti-PD1 therapy that targets the T-cell checkpoint protein PD1, in conjunction with the standard dose of trastuzumab. No dose-limiting toxicities (DLTs) were observed.

In phase II, the investigators enrolled 40 patients and 12 patients to the PDL1-positive and PDL1-negative cohorts, respectively. Patients received 200mg of pembrolizumab every three weeks in combination with the standard dose of trastuzumab for 24 months or until disease progression.

In the PDL1-positive intent-to-treat population, the trial met its primary endpoint with an objective response rate (ORR) of 15 percent and disease control rate (DCR) of 25 percent. In a subgroup of PDL1-positive patients with 5 percent or more TILs present in the metastatic lesion, the ORR was 39 percent and the DCR was 47 percent, suggesting that quantification of TILs may help identify patients who will most benefit from this treatment. No responses were observed in the PD-L1 negative cohort.

Five (10.8 percent) patients in the PDL1-positive cohort continued to have no disease progression at the time of reporting, Loi noted. Pembrolizumab with trastuzumab was well tolerated, with grade 1-2 fatigue as the most commonly reported adverse event (21 percent). The most common immune-related adverse events reported were hyper- and hypo-thyroidism (grade 1-2 at 6.7 percent) and pneumonitis (grade 3-4 at 3.4 percent).

Final safety and efficacy results from this trial will be presented on Wednesday, Dec. 6.

“This proof-of-principle study suggests that immune evasion is a mechanism of resistance to trastuzumab and contributes to disease progression in advanced HER2-positive breast cancer,” noted Loi. “Our results suggest that PD1 inhibition is likely to become part of the treatment armamentarium of HER2-positive disease in the future.”

This study was sponsored and managed by the International Breast Cancer Study Group, in collaboration with the Breast International Group, and funded by Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the United States and Canada), through a subsidiary.

Press Release Published Date: 12/6/2017 8:20 AM
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Loftus, EileenTue, 5 Dec 2017 04:47:32
Ninety-Six Leading Cancer Researchers and Physician-Scientists, Including Eighteen Nobel Laureates, Urge Congress to Reach a Bipartisan Budget Agreement and Invest in Lifesaving Medical Researchhttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1122

The American Association for Cancer Research (AACR) today delivered a letter from the current AACR President and Past Presidents, as well as Fellows of the AACR Academy that include 18 Nobel Laureates, to urge leaders in the House and Senate to “move quickly to finalize a multi-year, bipartisan budget agreement that raises the caps on non-defense discretionary spending in FY 2018 imposed by the Budget Control Act.”

Lifting the caps is necessary for Congress to provide the National Institutes of Health (NIH) with $36.1 billion in fiscal year (FY) 2018, a $2 billion increase over FY 2017 that was approved by the Senate Appropriations Committee but has not yet passed the full Senate.

“It is only through robust, sustained, and predictable federal funding for research that we can continue to bring hope to the millions of people who are touched by cancer,” said Margaret Foti, PhD, MD (hc), AACR chief executive officer. “We are relying on many talented and dedicated early-career investigators to carry the torch of progress going forward, and if they are provided with the resources needed, their work will bring the future we all hope for – a future without cancer!”

The letter emphasizes that innovative cancer treatments, such as molecularly targeted therapeutics and immunotherapies, are now having an impact on patients at an ever-increasing pace. These advances, highlighted in the AACR Cancer Progress Report 2017, are the direct result of federal investments in laboratory, translational, and clinical research through the NIH and the National Cancer Institute (NCI). However, with the estimated 595,690 cancer deaths this year alone, including children and adults, there is still more work to be done, which is why sustained and substantial funding increases for the NIH and NCI remain essential for further progress.

The letter also calls attention to urgent issues facing early-career scientists, remarking that significant annual NIH funding increases are crucial if we are to secure a strong and diverse pipeline of early-career investigators who are committed to advancing cancer research and reducing cancer incidence, morbidity, and mortality.

There are 96 signatories of the letter.

Press Release Published Date: 12/6/2017 6:00 AM
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Beveridge, MichaelWed, 6 Dec 2017 09:48:24
Increasing the Dose Intensity of Chemotherapy May Lower the Risk of Breast Cancer Recurrence and Deathhttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1118

​SAN ANTONIO — Increasing the dose intensity of chemotherapy by either shortening the intervals between the cycles or by sequential administration instead of concurrent administration of the drugs reduced the risk of early-stage breast cancer recurrence and death compared with standard chemotherapy regimens, according to data from an EBCTCG meta-analysis study presented at the 2017 San Antonio Breast Cancer Symposium, held Dec. 5–9.

“The number of deaths from breast cancer in the United States and many other countries has halved over the last 30 years because of a series of step-by-step improvements in treatment that, together, add up to make a big difference,” said Richard Gray, MSc, professor of medical statistics in the Nuffield Department of Population Health at University of Oxford, United Kingdom. “It is important to continue to find out whether or not there are worthwhile benefits from one treatment compared to another.”

Gray and colleagues aimed to find out whether increasing the dose intensity of chemotherapy, meaning increasing the amount of drug delivered per unit time, was more effective at lowering breast cancer recurrence and death rates than standard chemotherapy regimens for patients with early-stage breast cancer. The dose-dense chemotherapy trials used the same chemotherapy agents at the same doses but administered every two weeks instead of every three weeks. The average weekly dose is therefore 1.5 times higher in the dose-dense group than with the standard schedule comparator, Gray explained.

“Another way of increasing the dose intensity of chemotherapy is to give the chemotherapeutics individually in sequence rather than administering all the drugs together at the same time,” said Gray. This sequential approach allows higher doses of the individual drugs to be used in each cycle while keeping the side effects manageable, he added.

For the meta-analysis, Gray and team used individual patient data from seven randomized trials (10,004 women) that tested chemotherapy given every two weeks versus every three weeks, and from nine randomized trials (11,533 women) that tested sequential versus concurrent anthracycline and taxane-based chemotherapies.

“We were surprised by how strong and consistent the findings from our study were,” Gray said.

Patients who received chemotherapy every two weeks were 17 percent and 15 percent less likely to have disease recurrence and die from breast cancer within 10 years, respectively, compared with those who received treatment every three weeks.

Similarly, patients who received sequential chemotherapy were 14 percent and 13 percent less likely to have disease recurrence and die from breast cancer within 10 years, respectively, compared with those who received concurrent treatment.

“The results apply to most women receiving chemotherapy for early-stage breast cancer: the 15 percent reduction in recurrence with dose-intense chemotherapy across all trials was similar in ER-positive and in ER-negative disease, and did not differ significantly by any other patient or tumor characteristics, including age, HER2 status, nodal status, tumor size, and grade,” noted Gray.

There were few additional side-effects with dose-intense schedule compared with standard schedule chemotherapy, and fewer patients who received dose-intense treatment died from non-breast cancer causes than those who received standard treatment.

“Some centers prefer giving chemotherapy every three weeks and offer treatment every two weeks less frequently because of concerns about side effects and uncertainty about the additional benefit. Looking at the data from large numbers of women receiving dose-intense chemotherapy, we have found no evidence to justify these concerns, and the results show consistent benefit from the more intense treatments,” Gray said.

A limitation of the study is that the chemotherapy used in the dose-intensification trials varied in the doses, the number of treatment cycles, and the agents used. So, although dose-intense chemotherapy is clearly more effective at eradicating cancers, it is difficult to recommend any one particular dose-intense chemotherapy regimen based on this study, said Gray.

This study was funded by Cancer Research UK and the UK Medical Research Council. Gray declares no conflicts of interest.

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Loftus, EileenTue, 5 Dec 2017 04:27:38
Adjuvant Trastuzumab Did Not Improve Outcomes for Patients With HER2-low Breast Cancerhttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1119

SAN ANTONIO — Adding trastuzumab (Herceptin) to standard adjuvant chemotherapy did not improve invasive disease–free survival for patients with early-stage breast cancer found to have low levels of HER2, as defined as immunohistochemistry (IHC) 1+ or 2+ and/or in situ hybridization (ISH) negative, according to data from the randomized, phase III NSABP-B-47 clinical trial presented at the 2017 San Antonio Breast Cancer Symposium, held Dec. 5–9.

“Current guidelines classify a breast cancer as HER2 positive if immunohistochemistry testing shows it has high levels of HER2 protein, defined as IHC 3+, or in situ hybridization shows it has increased numbers of copies of the HER2 gene, defined as ISH positive” said Louis Fehrenbacher, MD, medical director of Kaiser Permanente Oncology Clinical Trials and an oncologist with the Kaiser Permanente Vallejo Medical Center, California. “Adding one year of treatment with trastuzumab to standard adjuvant chemotherapy significantly reduces cancer recurrence and improves survival for patients with early-stage HER2-positive breast cancer.

“About 15 percent of breast cancers are HER2 positive, but another 45 percent have low levels of HER2, and these patients are not currently treated with adjuvant trastuzumab,” continued Fehrenbacher. “In some of the early trastuzumab clinical trials, there was a signal that patients with HER2-low breast cancer may benefit from the HER2-targeted therapeutic. We designed and conducted NSABP-B-47 to test in a large, rigorous clinical trial whether this was indeed the case.”

Fehrenbacher explained that although the data show that adding trastuzumab to standard adjuvant chemotherapy did not improve outcomes for patients with early-stage HER2-low breast cancer, it was vital to have conducted the study so that patients with this form of the disease can unequivocally know that trastuzumab is not a beneficial treatment for them. Trastuzumab treatment can cause serious adverse effects, including cardiotoxicity, so it is important to know that current guidelines defining HER2-positive status are valid and ensure that no patients are under- or overtreated, he said.

Fehrenbacher and colleagues enrolled 3,270 patients with early-stage breast cancer that was either IHC 1+, IHC 2+, and/or ISH negative in the trial. The patients were randomized 1:1 to standard adjuvant chemotherapy with or without a year of trastuzumab.

After a median follow-up of 46.1 months, 264 patients had either recurrence of their original breast cancer, a diagnosis of a new breast cancer, a diagnosis of new cancer outside the breast, or had died. These 264 events triggered analysis of the primary endpoint of the trial, invasive disease–free survival.

Among the 1,640 patients receiving trastuzumab, five-year invasive disease–free survival was 89.6 percent. It was 89.2 percent among the 1,630 patients who did not receive the HER2-targeted therapeutic. The findings did not differ if the patients were subdivided by HER2 IHC level, extent of lymph node involvement, or hormone receptor status.

In addition, five-year estimates for recurrence-free interval, distant recurrence–free interval, and overall survival were not statistically different for patients receiving trastuzumab compared with those not receiving trastuzumab.

This study was supported by funds from the National Cancer Institute and Genentech. Fehrenbacher declares no conflicts of interest.

Press Release Published Date: 12/6/2017 3:20 AM
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Loftus, EileenTue, 5 Dec 2017 04:34:56
AACR Congratulates President Dr. Michael A. Caligiuri on Appointment as President and Physician-in-Chief of City of Hope National Medical Centerhttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1117

​PHILADELPHIA — The American Associati​on for Cancer Research (AACR) congratulates President Michael A. Caligiuri, MD, on his appointment as president and physician-in-chief of City of Hope National Medical Center in Duarte, California. Caligiuri assumed the role as President of the AACR in April 2017 and will serve until April 2018.

“On behalf of the American Association for Cancer Research, I wish to extend our sincere congratulations to President Michael Caligiuri,” said Margaret Foti, PhD, MD (hc), chief executive officer of the AACR. “Dr. Caligiuri is a distinguished physician-scientist and highly esteemed leader, not only for the AACR, but for the cancer community at large. His dedication to accelerating the pace of discovery and its translation to the clinic will be invaluable to City of Hope, and in his new position he will be able to make a difference for humankind.”

Caligiuri was most recently director of The Ohio State University Comprehensive Cancer Center and CEO of the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute in Columbus. He begins his new role in February 2018.

Caligiuri is a renowned physician-scientist known for his work in immunology that is focused on human natural killer cells and their modulation for the treatment of leukemia, myeloma, and glioblastoma. Well over 1,500 cancer patients have been treated on clinical protocols that have emanated from the Caligiuri laboratory.

Caligiuri has been actively involved with the AACR since 1990, serving on the Board of Directors (2013-2016) and as chairperson of the Publications Committee since 2003. He has also served as a member of the Clinical and Translational Cancer Research Committee (2001-2004, 2012-present), a member of the Margaret Foti Award for Leadership and Extraordinary Achievements in Cancer Research Committee (2015); Landon Foundation-AACR INNOVATOR Award for Cancer Prevention Research Scientific Review Committee (2011); Pezcoller Foundation-AACR International Award for Cancer Research Selection Committee (2010); chairperson of the Annual Meeting Program Committee (2009); member of the Scientific Program and Scientific Review Committees for the Translational Cancer Medicine Meeting (2008); Steering Committee of the Cancer Immunology Working Group (2007-2012); Clinical Research and Experimental Therapeutics Awards Selection Committee (2004); chairperson (2002) and member (2001) of the Scientific Committee of the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics; member of the editorial boards of Molecular Cancer Therapeutics (2001-2005) and Clinical Cancer Research (1996-2008); associate editor of Cancer Research (2001-2003); member of the Science Policy and Legislative Affairs Committee (2001-2004, 2006-2009, 2012-2015); the Richard and Hinda Rosenthal Foundation Award Selection Committee (1999); and chairperson of the Membership Committee (1999).

He also served as a member of the faculty for the Scientist↔Survivor Program at the AACR Annual Meeting (2003-2009) and as a member of the faculty for the educational workshop, Methods in Clinical Cancer Research (2003-2007).

Caligiuri has been recognized with myriad honors and awards throughout his career, including the Director’s Service Award and the MERIT Award from the National Cancer Institute, the John Wayne Clinical Research Award from the Society of Surgical Oncologists, and the Emil J Freireich Award in Clinical Cancer Research from The University of Texas MD Anderson Cancer Center. He is an elected fellow of the American Association for the Advancement of Science, the American College of Physicians, and the Alpha Omega Honor Medical Society, as well as an elected member of the Association of American Physicians and the American Society for Clinical Investigation.

Caligiuri received his bachelor’s degree from the State University of New York at Buffalo; received his master’s and medical degrees from Stanford University in Stanford, California; completed a residency in internal medicine at Brigham and Women’s Hospital at Harvard Medical School and a fellowship in medical oncology, bone marrow transplantation, and immunology at Dana-Farber Cancer Institute in Boston.

Press Release Published Date: 11/30/2017 11:00 AM
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Loftus, EileenThu, 30 Nov 2017 04:05:05
Urban American-Indian and Alaskan Natives May Have Lower Survival Following Invasive Prostate and Breast Cancerhttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1116

​PHILADELPHIA — Compared with the non-Hispanic white (NHW) population, the urban American-Indian and Alaskan Native (AIAN) community was more likely to have lower survival rates following invasive prostate and breast cancer, according to results published in Cancer Research, a journal of the American Asso​ciation for Cancer Research.

“It’s been reported that the AIAN community has a higher cancer burden than other racial/ethnic groups,” said lead author Marc A. Emerson, MPH, PhD candidate, Department of Epidemiology, University of North Carolina at Chapel Hill. “However, accurate, population-based information on the cancer experience for this population residing in an urban setting is severely lacking.”

Previous AIAN data regarding cancer incidence and mortality are linked with the Indian Health Service (IHS); however, access to IHS facilities for the majority of AIANs is limited, as IHS clinics and hospitals are located near reservation lands, Emerson explained. Additionally, only members of federally recognized AIAN tribes qualify for treatment by the IHS. Altogether, it is estimated that up to 80 percent of the AIAN population cannot utilize IHS services, resulting in data acquisition that is not representative of the entire cohort, he said.

Senior author Laurel A. Habel, PhD, associate director for cancer research at the Kaiser Permanente Northern California (KPNC) Division of Research, and colleagues analyzed data from 582 AIAN and 82,696 NHW enrollees of KPNC, a health care system that covers roughly one-third of people living in the Bay Area and Central Valley in California. Participants were diagnosed with primary invasive breast, prostate, lung, or colorectal cancer between January 1997 and December 2015. As enrollees of the same comprehensive health plan, participants of this study had approximately equal access for both cancer treatment and preventative services. However, AIANs had a somewhat higher comorbidity burden as compared to NHWs.

“The AIAN population has a unique history of social, environmental, and cultural injustices that have impacted health,” noted Emerson. “As a result, many of these long-term exposures have resulted in an unequal contemporary burden of comorbid health conditions.”

In addition to comorbidity burden, Habel and colleagues compared cancer survival between the AIAN and NHW populations. They found that the AIAN community had an 87 percent increased risk for prostate cancer-specific mortality, and a 47 percent increased risk for all-cause mortality following invasive breast cancer, after controlling for patient factors, disease characteristics, and comorbidity status. Additional adjustment for income did not significantly change the outcomes. They did not observe higher overall or cancer-specific mortality for AIAN individuals with lung or colorectal cancer.

“Our results suggest that factors other than health insurance and income may play a role in the survival differences observed for breast and prostate cancer,” said Emerson, who was an Intramural Research Training Award fellow in the Division of Cancer Control and Population Sciences at the National Cancer Institute while conducting this work. “These factors could include differences in tumor biology or differences in aspects of treatment, such as adherence.”

Future studies on the tumor biology of cancers in the AIAN population and on adherence to cancer treatments could help better understand and address the disparities, Emerson said.
Limitations of the study include an inability to control for quality of care, adherence, or lifestyle factors that may vary across racial subgroups. “The electronic health records do not have data on some lifestyles and behaviors that may have influenced cancer outcomes,” Habel noted.

This study was sponsored by the National Cancer Institute and the National Institutes of Health. Habel and Emerson declare no conflicts of interest.

Press Release Published Date: 11/28/2017 7:05 PM
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Loftus, EileenWed, 29 Nov 2017 12:37:52
​Adult Survivors of Childhood Cancer Are More Likely to Develop High Blood Pressurehttp://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1115

PHILADELPHIA —People who survived childhood cancer were more than twice as likely as the general population to have high blood pressure (hypertension) as adults, according to results of a study published in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Associati​on for Cancer Research. 

“High blood pressure is an important modifiable risk factor that increases risk of heart problems in everyone,” said the study’s lead author, Todd M. Gibson, PhD, assistant faculty member in the Epidemiology/Cancer Control department at St. Jude Children’s Research Hospital in Memphis, Tennessee. “Research has shown that high blood pressure can have an even greater negative impact on survivors of childhood cancer who were treated with cardiotoxic therapies such as anthracyclines or chest radiation.” Todd M. Gibson, PhD

Gibson explained that improvements in treatment have dramatically increased survival rates from pediatric cancers, with about 83 percent of children surviving at least five years and many becoming long-term survivors. Today, an estimated 420,000 Americans are adult survivors of childhood cancer.

To assess the prevalence of high blood pressure among survivors of childhood cancer, Gibson and colleagues examined 3,016 adults who were part of the St. Jude Lifetime Cohort Study, which provides ongoing medical assessments of childhood cancer survivors to advance knowledge of their long-term health outcomes. Participants were considered to have high blood pressure if their systolic blood pressure was 140 or greater, their diastolic blood pressure was 90 or greater, or if they had been previously diagnosed with hypertension and were taking antihypertensive medication.

The study showed that the prevalence of hypertension was 2.6 times higher among childhood cancer survivors than expected, based on age-, sex-, race- and body mass index-specific rates in the general population.

The prevalence of hypertension increased over time: At age 30, 13 percent of the survivors had hypertension; at 40, 37 percent had hypertension, and by age 50, more than 70 percent of the survivors had hypertension. Gibson said the prevalence of hypertension in cancer survivors matched rates in the general population of people about a decade older.

Certain groups of survivors were the most likely to have hypertension: men; non-Hispanic blacks, older survivors, and those who were overweight or obese, the study showed.

The study found that exposure to radiotherapy or chemotherapy were not significantly associated with hypertension. Gibson said this finding was surprising, and suggests that the connection between childhood cancer survival and adult hypertension is multifactorial and worthy of future research. In the meantime, he said, clinicians should be mindful that survivors of childhood cancer are more likely than the general public to develop high blood pressure.

“The good news is that, unlike prior cancer therapy, high blood pressure is a modifiable risk factor,” Gibson noted. “Research is needed to identify effective interventions to prevent hypertension in survivors, but our results emphasize the importance of blood pressure surveillance and management.”

Gibson said a limitation of the study is that it was based on blood pressure measurements that were taken at a single study visit. A clinical diagnosis of hypertension typically requires measurements taken at multiple intervals, he explained. Also, Gibson added, the St. Jude Lifetime Cohort is a group of cancer survivors who undergo frequent clinical follow-up, so its participants may have benefited from being monitored and may, therefore, be in better health than survivors who have less comprehensive follow-up.

The study was funded by the National Cancer Institute and the American Lebanese Syrian Associated Charities. Gibson declares no conflicts of interest.

Press Release Published Date: 11/21/2017 7:05 PM
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Loftus, EileenWed, 22 Nov 2017 09:42:15