By Nancy Roach, the Founder of C3 and Chair of its Board of Directors

On November 4, the National Cancer Institute (NCI) held the 9th meeting of the Clinical Trials and Translational Research Advisory Committee (CTAC). CTAC advises NCI on the implementation of the 2006 recommendations from Clinical Trials Working Group and the 2008 recommendations for the Translational Research Working Group. There’s more information about NCI’s initiatives here.

I am one of two advocates who serve on CTAC, and as an ex-systems analyst, I’m always looking for ways to make government more efficient and accountable.  At the November 4 meeting, recommendations were presented to increase the efficiency of the clinical trial development process – from the time that a researcher presents a concept to NCI to the time that the trial is actually activated.  Under the leadership of Dr. James Doroshow, NCI and its partners are taking aggressive steps to de-bureaucratize publicly-funded cancer research, which will ultimately benefit patients by putting resources into research instead of process.

Following is a very brief overview of the background and the recommendations, with links to additional documentation. And believe it or not, zombies did come up in the discussion!

Editorial Comment:

C3 has made “bureaucracy-busting” a priority of its research program.  Much of the unproductive process is an unintended consequence of well-intentioned changes that evolved over time.  At the end of the day, patients are best served by an efficient research system that can get answers to important clinical questions safely and quickly.  We applaud the efforts of everyone involved with this effort, and look forward to the implementation of the changes.

Improving Operational Efficiency Initiative – Background

One of the initiatives that came out of the Clinical Trials Working Group was the Operational Efficiency Initiative, which is looking at two areas where operational efficiency could be improved:

• Increasing the rate of patient accrual so that trials can be completed faster
• Identifying and reducing institutional barriers (aka bureaucracy) that stretch the time needed to develop and launch clinical trials

NCI and CTAC took aim at the “institutional barriers” first.  Step one was analysis.  David Dilts and Alan Sandler reviewed and documented the process involved with starting trials.  Their analysis showed many places where the process was broken:

• Starting a phase 3 trial in a cooperative group takes from one to three YEARS
• 40% of phase 3 cooperative group trials enrolled fewer than 20% of the patients needed to get a result
• Trials that take longer than two years to develop enroll fewer patients
• Fixing the system required changes by everyone involved, including NCI and the cooperative groups.

Some problems they identified included:

• Tweaking – multiple reviews that changed “just one thing” which then required an additional round of reviews
• Deadline-denial – when deadlines were broken, there were no consequences
• An inability to say “no” – reviewers would ask submitters to “revise and resubmit” a trial proposal, instead of just saying “no” to the trial.

This is a very quick summary – Dilts’ papers are listed at the end for those who want to learn more, and his very entertaining presentation to NCI is here:

Activating and Opening Phase III Clinical Trials: A Process and Timing Study
Presented at 2007 NCI Clinical Trials Operations Committee (CTOC)

Step two involved further analysis to identify areas that need change. To that end, CTAC formed the Operational Efficiency Working Group (OEWG) which was charged with identifying ways to decrease the time needed to take a trial from concept submission to protocol launch.

The OEWG included 63 members:

• 10 Cooperative Group Chairs
• Pharma/Biotech
• 8 Cancer Center Directors
• Patient Advocates
• Clinical Investigators
• FDA
• Statisticians
• CMS
• Protocol/Trial Specialists
• CTSU
• NCI Clinical Trials Leadership and Staff
• Community Oncologist

The group looked at ways to decrease trial development time without impacting the quality of science or patient safety in 4 types of trials:

• Cooperative Group Phase III Trials
• Cancer Center Investigator Initiated Trials
• Investigational Drug Branch (IDB) Early Drug Development Phase II Trials
• Cancer Center Activation of Cooperative Group Trials

OEWG recommendations

Step 3 was developing the recommendations for what to change and how to change it. The OEWG set timeline targets which dramatically cut the time that NCI, cooperative groups and cancer centers spend on protocol development.  In the chart below, the current median days to activation are shown in blue, and the OEWG targets are in red.  The OEWG targets do not include interactions with Institutional Review Boards (IRB) or industry.  In addition, NCI set firm termination deadlines (green) which provide some “give” to the targets in order to deal with IRBs and industry.

Generated from information presented at 11-4-2009 CTAC meeting

The firm termination deadlines (green) take effect in January 2011.  In other words, if a phase III trial takes longer than 2 years to develop and activate, the trial is terminated.

Here’s where zombies come in. In the past, some trials have hung around the development process for years, clogging up the system.  There wasn’t a clear path to getting those trials out of the system, even though a trial that takes more than two years to develop is very unlikely to succeed. Those trials have been nicknamed zombies.   Effective January 1, 2011, current zombies will be terminated, and the clock will start ticking as new trials enter the system.

The implementation of firm termination deadlines – no excuses allowed – is very new in the public research arena.   In order to get there, OEWG identified 11 specific recommendations which focus on streamlining the development of scientifically significant trials.   The recommendations emphasize:

• Real-time resolution of issues
• Working in parallel processes instead of sequential processes where possible
• Limiting the ability for concept and protocol tweaking
• Use of new specialists such as medical writers and dedicated trial development managers, and new tracking tools so that protocol progress can be monitored.

NCI will provide resources to implement these recommendations over the next year.

The full presentation from the November meeting is online:

Operational Efficiency Working Group (OEWG) Update – Dr. Doroshow (PDF)

The presentation contains more data that explains the timeline decisions, and gets into the detail of the recommendations and the support that will be provided to re-align the protocol development process at NCI, cooperative groups and cancer centers.

The next steps are:

• Prepare Phase I OEWG Final Report and begin implementation
• Launch OEWG Phase II addressing rate of accrual and time to trial completion

The next CTAC meeting is March 3, 2011, and I look forward to hearing a progress report.  These meetings are open to the public, and are held at Building 31, C Wing, 6th Floor, Conference Room 10 at the National Institutes of Health campus, 9000 Rockville Pike, Bethesda, Maryland.

References:

• Development of Clinical Trials in a Cooperative Group Setting:  The Eastern Cooperative Oncology Group, Dilts et al. Clinical Cancer Research, 14(11) June 1, 2008
• Processes to Activate Phase III Clinical Trials in a Cooperative Oncology Group: The Case of Cancer and Leukemia Group B, Dilts et al, Journal of Clinical Oncology, 24(28) October 1, 2006
• Invisible barriers to clinical trials: the impact of structural, infrastructural, and procedural barriers to opening oncology clinical trials. Dilts and Sandler, Journal of Clinical Oncology 24(28) October 1, 2006
• Activating and Opening Phase III Clinical Trials: A Process and Timing Study Presented at 2007 NCI Clinical Trials Operations Committee (CTOC)

By Catherine Knowles, C3’s Director of Policy

Democratic Senator Ben Nelson (NE) announced this afternoon that he will vote for cloture on the motion to proceed Saturday.

Continue reading to see exactly what Senator Nelson said, and for additional updates on the pending vote.

In explaining his support for the procedural vote, Senator Nelson said “[t]he Senate should start trying to fix a healthcare system that costs too much and delivers too little for Nebraskans.  Throughout my Senate career, I have consistently rejected efforts to obstruct.  That’s what the vote on the motion to proceed is all about. It is not for or against the new Senate healthcare bill released Wednesday.  It is only to begin debate and an opportunity to make improvements.  If you don’t like a bill, why block your own opportunity to amend it?”.

The Senate began debate on the Patient Protection and Affordable Care Act this morning.  A cloture vote on the motion to proceed is expected around 8pm on Saturday.  You can watch the debate and vote online.

If, as expected, Senate Majority Leader Reid gets the 60 votes he needs on Saturday, three weeks of debate on the Patient Protection and Affordable Care Act will begin the week of November 30 and continue until right before Christmas.  At the conclusion of debate and consideration of amendments, a vote on final passage of the health reform bill is expected sometime between December 18-23.

Numerous amendments are expected during Senate consideration of the bill, but even as was introduced this week, the Senate bill is very different from the bill that the House passed earlier this month which means that both chambers will have to conference their bills.  House and Senate leadership has indicated that they would like to consider the conference report/final bill the second or third week of January in order to send a final health reform bill to the President before the State of the Union address.

By Catherine Knowles, C3’s Director of Policy

On Thursday afternoon, Senate Majority Leader Reid (NV) set the procedural wheels in motion for a vote on the Patient Protection and Affordable Care Act.

The first procedural vote is expected around 8pm on Saturday.  It will be a cloture vote on the motion to proceed.  Majority Leader Reid is working to line up the 60 votes needed to pass the cloture motion (a cloture motion must be approved by three-fifths of the Senate).

Continue reading for more information on the upcoming Senate vote as well as a summary of some of the provisions included in the Senate bill that C3 thinks are important for people living with colorectal cancer.

Typically, a cloture vote will be followed by a second procedural vote – a vote on the motion to proceed.  This vote requires a simple majority vote to pass.  However, Senate Republicans have agreed to waive this second procedural vote and forego reading the bill on the Senate floor in exchange for an all-day debate on the bill on Saturday (without this agreement, the Senate rules would have only required one hour of debate before the cloture vote).

The New York Times reports that Democratic Sens. Ben Nelson (NE), Mary Landrieu (LA), and Blanche Lincoln (AR) “are proving tough sells” on health care reform, “raising the prospect that one or perhaps all three of them could scuttle the bill before the fight over it even begins on the Senate floor.”  Should the cloture vote fail, Democrats may be forced “to regroup and redraw the measure or even switch to a more contentious procedural shortcut around the need for a 60-vote majority.”  Politico has a good article on the fast track options for moving the legislation forward.

Be sure to tune in and watch the debate and vote on Saturday.  You can watch the vote on C-Span’s website.

The $849 billion Patient Protection and Affordable Care Act includes a public option that will extend health insurance coverage to 31 million Americans.  The reimbursement rates for the public plan will not be tied to Medicare, and co-ops will still be offered.  The bill will create an insurance exchange where people can compare and purchase health insurance, it expands Medicaid coverage to those earning 133 percent of the federal poverty level, and it offers subsidies to help those without employer sponsored insurance purchase health insurance.

Increasing the number of Americans with health insurance will help reduce mortality rates from colorectal cancer.  Many studies show that people who are uninsured are substantially less likely to be screened for colorectal cancer.  In addition, insurance status strongly influences survival among those diagnosed with colorectal cancer – individuals with private insurance who are diagnosed with Stage II colorectal cancer have better survival outcomes than individuals who are uninsured and are diagnosed with Stage I colorectal cancer.

Like the House health reform bill, the Senate bill eliminates pre-existing condition exclusions.  Eliminating pre-existing conditions exclusions is very important for cancer patients.  Pre-existing condition exclusions lock the millions of Americans with at least one chronic illness (nearly one third of the population) into existing plans and employment.

The bill will eliminate cost-sharing requirements for all preventive services (including colorectal cancer screening) that have a United States Preventive Services Task Force (USPSTF) A/B rating, and require coverage of these tests by private insurance.

It also has a section regarding community preventive screenings, and specifically lists cancer screenings as one of the community interventions needed to improve public health.

The bill establishes a prevention and public health fund to be administered through the Office of the Secretary at the Department of Health and Human Services to provide for an expanded and sustained national investment in prevention and public health programs.  This new fund will support public health activities including prevention research and health screenings.

Many colorectal cancer patients face a lifetime of cancer treatment.  Caps on insurance result in very difficult decisions about the care they will receive and how they are going to pay for it.  The Patient Protection and Affordable Care Act eliminates “unreasonable annual benefits” and lifetime limits on the dollar value of benefits for any participant or beneficiary for all group health plans and health insurance coverage required to provide “essential health benefits” (i.e., any insurance company or plan that participates in the new health insurance exchange).

Senate Democrats have complied a section-by-section summary of the bill along with a timeline for implementation of the various provisions in the bill.  In addition, the Congressional Budget Office (CBO) has reviewed the legislation.  CBO’s analysis and cost estimate of the bill is available online.

The cloture vote on Saturday is an important step in getting a final health reform bill sent to the President, but there is still a long road ahead for health reform and many areas where the pending bills could be improved.

C3 has been closely following the various health reform proposals introduced in Congress, and will continue to work with legislators to advocate for the access to care that is critical to preventing, treating and beating colorectal cancer.  Please feel free to share your thoughts with us by leaving comments below.

By Nancy Roach, the Founder of C3 and Chair of its Board of Directors

A National Cancer Institute (NCI) working group has developed recommendations about how to engage advocates effectively in NCI research activities.  The recommendations are open to public comment until November 30, 2009.  Rather than go into detail about the recommendations, I will explain from my personal experience why I feel they are important and present C3’s feedback.

The recommendations fill an existing vacuum

The first time I was invited to participate in a research meeting as a research advocate, I was excited, but uncertain about my role and responsibilities.  I knew I was attending a research meeting  and understood the basics of research.  But I didn’t understand how the research organizations were organized (what the heck was CTEP anyway?), how they functioned, or why I was invited to the meeting.

I left the three-hour meeting feeling like a failure.  I’d sat in the room listening to researchers talk about colorectal cancer research ideas and had no idea what I was supposed to do.  I didn’t understand the difference between concepts, protocols, and active trials and couldn’t decipher the acronym-speak.  When I was asked if I thought patients would be interested in a specific trial, I had no way to evaluate the question.

Over time, I learned that my experience was not unusual.  Some groups welcomed advocates as full partners in the clinical research process, and some advocates helped shape meaningful research.  Other groups welcomed advocates to meetings but not in the nitty-gritty of research development, and other advocates spoke rarely if at all.  In other words, our role was frequently unclear to everyone including ourselves.

The lack of clarity meant that developing training and support was hard – if we don’t know what we’re supposed to do, how can we learn how to do it?  And if researchers don’t know why we are in the room, why would they be interested in our feedback?  After all, most of the researchers have advanced degrees in their specialties.  We are there because we, or someone we love, got sick.  Why should our opinions matter?

Time for change

In 2007, NCI Director John Niederhuber asked the NCI Director Consumer Liaison Group (DCLG) for recommendations on how to best involve research advocates in NCI activities.  The DCLG constituted the Advocates in Research Working Group (ARWG) and charged them to work with NCI’s Office of Advocacy Relations (OAR) to develop recommendations.

The six high-level recommendations provide a framework for identifying, involving and supporting advocates, and address issues such as training, compensation and support.  They were presented to the DCLG in October 2009. This PowerPoint presentation reviews the process and participants behind the ARWG, and sets out the recommendations in some detail.

C3’s response

C3, through my participation, was honored to be involved with this effort from the start, along with other advocates, researchers, NCI staff and OAR.  I frequently reached out to C3’s research advocates to get their individual and collective feedback on the issues.  Given that C3 helped shape the recommendations, it’s not surprising that we are pleased with the outcome.  We believe the recommendations will ensure that when advocates participate in research activities:

• Advocates will understand how to fulfill their role effectively
• Other participants will understand the value of advocate participation
• Over time, the value of advocate participation will be evaluated and thereby improved

Aspects of the recommendations which we strongly support include:

• Development of a trained advocate cadre which allows advocates to cycle in and out of activities, and promotes engagement of new advocates
• Clear articulation of conflict-of-interest principles
• Training and orientation for advocates as to their role in researchTraining and orientation for researchers as to the role of the advocates in research

Having said that, no doubt there are areas where the recommendations will evolve once theory hits reality.  For example, some of the recommendations could hold advocates to a different standard than the other players at the research table.  Recommendation 2.1 (slide 26) states that NCI will develop inclusion and removal criteria for the advocate cadre.  The intent behind the recommendation is aimed at identifying the knowledge and skills that advocates need for successful engagement.  For example, if an advocate needs human subject protection training prior to engagement, that could be one of the criteria. At the same time, researchers aren’t subjected to this kind of explicit vetting by NCI prior to engagement.  Should they be?  If not, should advocates?  We are comfortable with the intent behind the recommendation, and will watch the reality of implementation with great interest.

We believe that at this point, forward motion is the best way to identify and resolve problems.

Forward motion is where the real challenges will occur.  Implementation will take time, resources and a culture change, because substantive involvement of advocates in research can be unusual.  Personally, I’m always surprised by that, because I view advocates as the customers of cancer research – and who develops a product without involving customers?  However, our involvement with clinical research is more complex to figure out than our involvement in the development of a new car or toothpaste, and these recommendations are a step in the right direction.

C3 urges NCI leadership to accept these recommendations and provide the resources and support necessary to implement them.  Dr. Niederhuber, the current NCI Director, has been committed to these efforts.  We hope that if and when a new Director is appointed, he or she shows the same level of commitment to our effective involvement with the system.

Picoplatin can be as effective as oxaliplatin as an initial treatment for advanced colorectal cancer but has less neuropathy.

Updated information comparing picoplatin in combination with 5-FU and leucovorin (FOLPI) to the standard oxaliplatin treatment (FOLFOX) found similar response rates.  About half of patients on both treatments were alive a year later.  However, there was significantly less neuropathy overall with FOLPI and no severe neuropathy.

FOLPI did have substantially more serious problems with lowered blood counts than FOLFOX. 

Information from 100 patients randomized to receive either FOLPI or FOLFOX for metastatic colorectal cancer was reported during the poster session at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics meeting in Boston on Tuesday, November 17.

Three out of four patients in both study arms had disease control — 73 percent of patients on FOLPI had either a complete response, partial response, or stable disease, while 76 percent of FOLFOX patients had similar results.  A year after beginning treatment, 52 percent of FOLPI patients were alive compared to 55 percent of those who got FOLFOX.

Neuropathy was evaluated using a patient questionnaire and by a neurologist who didn’t know which treatment patients were receiving.

Serious side effect profiles were quite different between the two treatment regimens. While there was significantly less neuropathy overall and no severe neuropathy on FOLPI, the picoplatin combination led seriously lowered blood counts in more than half of all patients.  Grade 3 or 4 adverse events were:

• neutropenia in 57 percent of FOLPI compared to 22 percent with FOLFOX.
• lowered platelets (thrombocytopenia)  in 43 percent of FOLPI compared to12 percent of  FOLFOX
• anemia in 22 percent of FOLPI compared to none in FOLFOX
• neuropathy in no FOLPI patients compared to 16 percent of FOLFOX

One patients in the FOLPI arm was treated for a fever associated with neutropenia but recovered and went on to have a complete response.

One in five patients on both study arms had to stop treatment because of side effects, most often neuropathy for FOLFOX (10 percent) and lowered blood counts for FOLPI (14 percent).

FOLPI required considerably more support to regain blood counts (neutrophil growth factors, platelet transfusions, RBC transfusions and erythropoietin) than did FOLFOX.

Robert De Jager of Poinard Pharmaceuticals and his study team concluded,

Neurotoxicity with FOLPI was less frequent and less severe compared to FOLFOX. Hematologic toxicity with FOLPI was manageable. FOLPI treatment of 1st line CRC had similar disease control and survival rates to FOLFOX supporting picoplatin as a potential neuropathy-sparing alternative to the use of oxaliplatin.

SOURCE: De Jager et al., Abstract B49: FOLPI (picoplatin/5-fluorouracil/leucovorin) versus modified FOLFOX-6 as a neuropathy-sparing first-line therapy for colorectal cancer, AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference 2009.

Disclosure: C3 has accepted funding for projects and educational programs from Poinard Pharmaceuticals in the form of unrestricted educational grants. C3 has ultimate authority over website content.

Colorectal cancer patients 65 and older without other serious medical problems benefitted when Avastin® (bevacizumab) was added to chemotherapy.

Combining results of four randomized clinical trials of Avastin and chemotherapy in patients with advanced colorectal cancer, researchers found that adding Avastin increased both the time older patients lived and the time before their cancer got worse.

Patients who were 70 and older had similar improvements.

There were more serious problems caused by blood clots (thromboembolic events) in patients who got Avastin, mostly related to arterial events.  However, other serious side effects were no more common in older patients than in those who were younger than 65.

Although two-thirds of patients with advanced colorectal cancer are 65 or older and four out of ten are older than 74, older patients are not well represented in clinical trials.  Even when there are no age limits on trials, they may not be enrolled because of other medical problems or a conservative approach to treatment of the elderly.

Therefore, to get a clearer idea of how adding Avastin to chemotherapy affects patients 65 and older, the research team combined information from three first-line and one second-line trial of Avastin and chemotherapy together including 1,100 patients who were 65 or older.

They found that both progression-free survival and overall survival improved when Avastin was added to chemo, and that age made little difference in benefits.

Progression-free survival time with and without Avastin was:

• For those under 65:  6.7 months vs 9.5 months
• Those 65 and older:  6.9 months vs 9.3 months
• Those 70 and older:  6.4 months vs 9.2 months

Overall survival time with and without Avastin was:

• For under 65: 16.5 months vs 19.9 months
• 65 and older:  15.0 months vs 17.9 months
• 70 and older:  14.1 months vs 17.4 months

As patients got older arterial thromoembolytic events (ATE) such as heart attack, stroke, TIA’s, and angina increased with the addition of Avastin.

• Under 65:  no difference in ATEs was found — 2 percent in both Avastin and non-Avastin groups
• 65 and older: 5.7 percent ATE for Avastin compared to 2.5 in non-Avastin group
• 70 and older: 6.7 percent ATE for Avastin, 3.2 with no Avastin

Age made no difference in other serious side effects including bleeding, hypertension, and gastrointestinal perforations.

The study authors point out that patients in clinical trials are carefully chosen and may not reflect the health of a patients in the general population.  They warn that overall health should be carefully assessed before beginning treatment.

James Cassidy and his colleagues wrote,

In conclusion, this pooled analysis of data from phase II and III metastatic colorectal cancer studies demonstrates that bevacizumab in combination with chemotherapy had a similar impact on PFS and OS in protocol-eligible older versus younger patients. Careful patient selection, however, remains important and should include an objective assessment of the patient’s physical and mental status.

SOURCE: Cassidy et al., Journal of Cancer Research and Clinical Oncology, Online First November 10, 2009.
Disclosure: C3 has accepted funding for projects and educational programs from Genentech in the form of unrestricted educational grants. C3 has ultimate authority over website content.

Drugs to treat anemia in older cancer patients increased their risk of blood clots and didn’t reduce the need for blood transfusions.

Among over 56,000 cancer patients 65 and older treated in community settings from 1991 through 2002, 27 percent received an erythropoiesis-stimulating agent (ESA).   Fifteen percent of those who got ESAs developed a blood clot (venous thromboembolism) compared to 10 percent of patients who didn’t have ESA treatment.

Although the goal of ESAs was to reduce the need for blood transfusions, the percentage of transfusions remained steady at 22 percent each year from 1991 through 2002.  Overall survival didn’t differ between the patients who received ESAs and those who didn’t.

Chemotherapy can cause anemia when the bone marrow doesn’t keep up with the need to replace normally lost red blood cells. Erythropoiesis-stimulating agents such as Procrit® and Epogen® (epoetin alfa) and Aranesp® (darbepoetin alfa) stimulate the bone marrow to produce new red blood cells.  Ideally, use of ESAs should reduce the need for blood transfusions during chemo.

However, when researchers reviewed data in the Surveillance, Epidemiology, and End Results (SEER)–Medicare database for patients who were diagnosed with colon, lung, or breast cancer or with lymphoma from January 1991, through December 2002 and who received chemotherapy, they found no difference in blood transfusion rates.

They did find more blood clots, both in deep leg veins and in the lungs, among those who were treated with ESAs.  The rate of venous thromboembolism was 14.3 percent in the ESA patients and 9.8 percent in patients who didn’t get ESAs.

After FDA approval of ESAs, their use increased rapidly.  In 1991, 4.8 percent of patients got an ESA, but by 1992 nearly half of all chemotherapy patients in the SEER-Medicare database (45.9 percent) received ESA treatment.

Writing in the Journal of the National Cancer Institute, Dawn L. Hershman, MD, and her colleagues concluded,

Use of erythropoiesis-stimulating agent increased rapidly after its approval in 1991, but the blood transfusion rate did not change. Use of erythropoiesis-stimulating agents was associated with an increased risk of venous thromboembolism but not of mortality.

The FDA-approved label for Aranesp, Epogen, and Procrit limit their use to patients with anemia who are receiving chemotherapy.  They are not appropriate for anemic cancer patients not on chemo or for cancer patients whose treatment goal is cure.  A Medication Guide has been developed to help patients discuss the use of ESAs with their doctors.

SOURCE: Hershman et al., Journal of the National Cancer Institute, Advance Access online November 10, 2009.

Disclosure: C3 has accepted funding for projects and educational programs from Amgen in the form of unrestricted educational grants. C3 has ultimate authority over website content.

Briefly: African Americans are diagnosed with colorectal cancer at later stages and have surgery less often which contributes to their poorer survival.  Women have a greater risk of a missed or early colorectal cancer after a negative colonoscopy.

If you can’t have a loved one with you during a painful procedure, just looking at your partner’s picture may make it hurt less.

The American Society for Radiation Oncology has a new website for patients, and open enrollment for Medicare plan coverage begins on November 15 and extends through the end of the year.

Research News

• African Americans were more likely to die of colorectal cancer in a study of over 13,000 patients.  They were more likely to have stage IV disease when diagnosed and less likely to have surgery.   But after late stage and lack of surgery were taken into account, racial differences in survival disappeared.  Writing in the November 2009 issue of the Journal of the American College of Surgeons, Dr. Timothy L. Fitzgerald and team said, “These data suggest that improvements in screening and rates of operation may reduce differences in colorectal cancer outcomes between African-American and Caucasian patients.”
• Canadian women were more likely than men to be diagnosed with an early colorectal cancer in the three years after a negative colonoscopy.  Researchers in Manitoba studied billing records for nearly 46,000 patients who had a clear colonoscopy and found that women with a negative colonoscopy were about as likely as women in the general population to develop colon cancer during the first three years after their test.  Then their risk dropped to about 40 to 50 percent lower.  The men’s  risk was 40 to 50 percent lower throughout the follow-up period.  Older women and those whose colonoscopy wasn’t done by a gastroenterologist were the most likely to have a missed or early colorectal cancer.   Harminder Singh MD, MPH and his team at the University of Manitoba reported their results in the American Journal of Gastroenterology online November 10, 2009.
• Looking at the picture of a loved one or holding your boyfriend’s hand reduces painful feelings, according to a study done by psychologists at UCLA. Women reported less pain when heat was applied to their forearm if they were holding their partner’s hand rather than a stranger’s hand or a ball during the experiment.  Just looking at a picture of their loved one also reduced the amount of pain they said they had.  Sarah Master PhD led the study.

Other Headlines

• The American Society for Radiation Oncology (ASTRO) has launched a newly designed patient website RT Answers. The new site is easier to navigate and includes more pictures.  The front page helps patients search for a radiation oncologist and provides a gateway to treatment information.
• Medicare beneficiaries can make new coverage choices during the annual open enrollment period from November 15 through December 31.   Online comparisons of original Medicare, Medicare Advantage, and supplemental Medigap policies are available from CMS.  Also changes in Part D Prescription Drug coverage plans can be made during open enrollment.

Deciding whether small colon polyps were adenomas or less dangerous hyperplastic ones can be done safely during the colonoscopy exam itself.  Avoiding the need for an additional pathology test could make diagnosis faster and less expensive.

Adenomas have the potential to develop into colorectal cancer, but not all colon polyps are adenomas.  Standard procedure is to remove all polyps seen during a colonoscopy and send them to the pathology lab for testing.   However, doctors in London were able to accurately predict which polyps were adenomas more than 9 out of 10 times with colonoscopy alone.

During colonoscopies following up on positive fecal occult blood tests (FOBT) at St. Mark’s Hospital, four endoscopists predicted whether pathology tests would show an adenoma or a hyperplastic polyp based what they saw during the exam.

The optical diagnosis was based on colonoscopy using high-definition white light, followed by narrow-band imaging without magnification and chromoendoscopy, as needed.

In 130 patients, they found 363 polyps smaller than 10 millimeters, 278 of which were diagnosed both during the optical colonoscopy and by histopathology.  Of those 80 were not neoplastic, meaning they weren’t the kind that turn into cancer.

Optical colonoscopy accurately diagnosed 186 of 198 adenomas and 55 of 62 hyperplastic polyps or 94 percent of adenomas and 89 percent of hyperplastic polyps.  Overall accuracy was 93 percent.

Based on optical colonoscopy alone 82 patients could be told when to return for a follow-up exam, and the pathology report agreed with the follow-up interval for 80 of them or 98 percent.

Dr. Ana Ignjatovic and her team wrote,

For polyps less than 10 mm in size, in-vivo optical diagnosis seems to be an acceptable strategy to assess polyp histopathology and future surveillance intervals. Dispensing with formal histopathology for most small polyps found at colonoscopy could improve the efficiency of the procedure and lead to substantial savings in time and cost.

SOURCE:  Ignjatovic et al., The Lancet Oncology, Early Online Publication, November 11, 2009.

Colorectal cancer patients whose CEA blood tests rise at the beginning of chemotherapy and then fall (CEA flare) do better than patients with a consistently rising CEA.   CEA flares don’t necessarily predict worsening cancer.

Compared to patients with consistently rising carcinoembryonic antigen (CEA), patients who had a CEA flare had more tumor shrinkage, longer time before their cancer got worse, and longer survival time.

Researchers measured CEA before chemotherapy started and at least twice during chemo in patients with advanced colorectal cancer who were receiving their first course of chemotherapy.

They grouped patients according to how the CEA measurements changed over time:

• flare
  
• decreasing CEA
• normal baseline CEA
• stable CEA
• increasing CEA

Comparing patients with increasing CEA measurements to patients whose CEA rose and then fell (flared):

• Overall response rate was 11 percent in increasing CEAs compared to 73 percent in flares.
• Progression-free survival time was 3.1 months compared to 8.3 months with flares.
• Overall survival was 10.9 months compared to 17.7 months when CEA flared.

A. S. Strimpakos and colleagues at the Royal Marsden Hospital in London concluded,

Compared with patients with rising CEA, flare was an independent favourable predictive and prognostic factor for tumour response and survival.

More information on the CEA flare during first-line chemotherapy  is available from Dr. Strimpakos’ poster presented at the 2009 GI Symposium.

SOURCE: Strimpakos et al., Annals of Oncology, Advance Access, October 27, 2009.