CancerNews.US

New prostate cancer drug, Xofigo, gains FDA fast-track approval earlier this week

noreply@blogger.com (Pat and Pattie Killingsworth) — Fri, 17 May 2013 15:56:00 +0000

Only 3 months benefit? More discouraging than encouraging, don't you think?

Bayer's Xofigo for Prostate Cancer Gets Fast Approval

By John Gever, Deputy Managing Editor, MedPage Today

Published: May 15, 2013

SILVER SPRING, Md. -- The FDA has approved radium-223 dichloride (Xofigo) for treating bone metastases from castration-resistant prostate cancer, the agency said Wednesday. Its specific indication is for men with symptomatic, late-stage, castration-resistant prostate cancer with metastases in bone but not other organs, following conventional medical and/or surgical therapy to reduce testosterone levels.

The approval was based primarily on a placebo-controlled trial in 809 patients that showed a median overall survival time of 14 months in those receiving the drug compared with 11.2 months in the placebo group. Patients in the trial also received other treatments judged to be clinically appropriate on an individual basis.
Radium-223 dichloride binds chemically to minerals in bone "to deliver radiation directly to bone tumors, limiting the damage to surrounding tissues," said Richard Pazdur, MD, director of the FDA's Office of Hematology and Oncology Products, in a statement.

The approval, made through the agency's priority review process, came 3 months before the FDA's Aug. 14 deadline to render a decision.

Adverse effects seen with the drug in clinical trials included nausea, diarrhea, vomiting, and swelling of the leg, ankle, or foot, the FDA said. Hematologic effects included anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia.

The drug was developed by Bayer Pharmaceuticals, Wayne, N.J.

Some good news on the celebrity cancer front...

noreply@blogger.com (Pat and Pattie Killingsworth) — Tue, 07 May 2013 02:27:00 +0000

Not sure if he can legitimately claim that pot cured his prostate cancer, but leave it to Tommy to try:

Tommy Chong Prostate Cancer-Free, Comedian Reports

Posted on May 6, 2013 - SFgate.com

Activist and comedian Tommy Chong claims he is cancer-free today on website Celebstoner.com.

“I brought my PSA numbers down drastically and eliminated the cancer threat… That’s right, I kicked cancer’s ass! So the magic plant does cure cancer with the right diet and supplements. I’m due for another blood test, MRI, etc., but I feel the best I’ve felt in years.”

Chong announced last year that he had been diagnosed with prostate cancer, a severe but treatable form or cancer if caught early. Chong reports avoiding expensive, experimental treatments for dietary change, supplements and hemp oil.

“With the diet, the supplements and the hash oil, plus a session with a world-renowned healer, Adam Dreamhealer, I’m cancer-free,” he wrote. And now for a celebration joint of the finest Kush.”

Doctors define a cancer treatment as a “cure” if a patient lives five years without the return of the cancer.

Feel good and keep smiling; Tommy is! Pat

Former Notre Dame basketball coach diagnosed with bladder cancer

noreply@blogger.com (Pat and Pattie Killingsworth) — Fri, 26 Apr 2013 21:03:00 +0000

As our society ages, more and more TV and movie celebrities have been and will be diagnosed with cancer. ESPN released this unfortunate news last night. Here's Sports Illustrated's take:

ESPN’s Digger Phelps diagnosed with bladder cancer

ESPN college basketball analyst Digger Phelps has been diagnosed with bladder cancer, the network announced Thursday night.

The network said that Phelps has undergone surgery to treat the cancer and will begin follow-up treatment next week near his home in South Bend, Ind. Phelps said in a statement that ”he and his family appreciate your thoughts and prayers as he prepares for the 2013-2014 college basketball season,” according to ESPN.

Phelps, 71, has been a major face of college basketball for more than four decades. He coached the Notre Dame men’s basketball team from 1971-91, where he memorably led the Irish to an upset over No. 1 UCLA record 88-game winning streak. He has been an ESPN analyst since 1993.

I'm sure I join all of our readers here, at HWC, MMB and MyelomaNews.com wishing Digger well.

Sometimes it's hard, but feel good and keep smiling! Pat

Click-on the headline link below to read all about it...

noreply@blogger.com (Pat and Pattie Killingsworth) — Wed, 17 Apr 2013 16:58:00 +0000

Supreme Court skeptical of patent on breast cancer gene

Richard Wolf, USA TODAY, April 15, 2013

A decision against the patent would be a victory for competing geneticists and researchers as well as breast cancer advocacy groups. But a compromise may be more likely.

Pfizer's experimental breast cancer drug gets fast-tracked by FDA

noreply@blogger.com (Pat and Pattie Killingsworth) — Fri, 12 Apr 2013 15:14:00 +0000

Last post had to do with ovarian cancer. This one breast cancer. Baby steps helping women with cancer issues. BRAVO!

Breast cancer drug gets breakthrough label

Linda A. Johnson, Associated Press

TRENTON, N.J. — Pfizer Inc. said Wednesday that its experimental pill for advanced, often deadly breast cancer has been designated as a breakthrough therapy by the Food and Drug Administration.
Pfizer shares jumped nearly 3% following the news.

The breakthrough designation, created under legislation enacted last summer to fund and improve operations of the FDA, is meant to speed up development and review of experimental treatments that are seen as big advances over existing therapies for serious diseases. Pfizer is working with the agency to determine exactly what research results it will need to apply for approval of the drug.

Palbociclib is being evaluated as an initial treatment for the biggest subgroup of postmenopausal women whose breast cancer is locally advanced or has spread elsewhere in the body. About 60% of women with such advanced breast cancer have tumors classified as ER+, or estrogen-receptor positive, but HER2-, or lacking an excess of the growth-promoting protein HER2.

Estrogen-receptor positive tumors have proteins inside and on the surface of their cells to which the estrogen hormone can attach and then fuel growth of cells. These tumors tend to grow slowly and can be fought with drugs that block estrogen's effects.

Meanwhile, about 80% of breast cancer tumor cells are HER2 negative. That means that unlike HER2 positive tumors, they don't produce too much of the HER2 protein, which makes tumors grow and spread more aggressively than in other breast cancer types.

New York-based Pfizer is currently running a late-stage study of palbociclib at multiple centers, comparing its effects when used in combination with letrozole with the effects of letrozole alone. Letrozole, sold under the brand name Femara for about the past 15 years, is a pill that works by inhibiting aromatase. That's an enzyme in the adrenal glands that makes estrogen.

According to Pfizer, palbociclib targets enzymes called cyclin dependent kinases 4 and 6. By inhibiting those enzymes, the drug has been shown in laboratory studies to block cell growth and suppress copying of the DNA of the cancer cells. Pfizer, which has made research on cancer medicines a priority in recent years, also is testing palbociclib as a treatment for other cancers.

I'm not familiar with this new "breakthrough designation." I am familiar with "fast tracking" a drug. Sounds like the same type of thing...

Feel good and keep smiling! Pat

New immunotherapy shows very good response in new ovarian cancer study

noreply@blogger.com (Pat and Pattie Killingsworth) — Mon, 08 Apr 2013 01:52:00 +0000

Funny I would be getting this news via China! Its the new world we live in...

Vaccine shows promise for ovarian cancer in US

China Daily

WASHINGTON - US scientists have developed an experimental vaccine against advanced ovarian cancer that triggers anti-tumor immune responses using cells made from patients' own tumor.

The vaccine provoked a positive response in 61 percent of woman with stage 3 or 4 ovarian cancer, according to a report presented Saturday at the American Association for Cancer Research annual meeting in Washington.

The University of Pennsylvania researchers first isolated immune cells called dendritic cells from patient's blood. They then created individualized vaccines by exposing each patient's dendritic cells to her own tumor tissue that had been collected during surgery. They found 19 out of 31 patients clinical benefit after vaccine treatment and developed an antitumor immune response.

Of these 19 patients, eight had no measurable disease at the end of the study and remained on maintenance vaccine therapy. One patient of the eight patients remained disease-free for 42 months following vaccine treatment, they said. While vaccination therapy alone showed about a 61-percent clinical benefit, said lead author Lana Kandalaft, the combination of both therapies showed about a 75-percent benefit.

Both treatments were given in conjunction with bevacizumab, a drug that controls blood vessel growth.
"We offer patients with ovarian cancer a potential therapy with minor side effects and a good quality of life," Kandalaft said. The researchers said they will continue to work to improve the vaccine platform to further enhance its efficacy.

I asked Pat what he thought about this. He felt that these were impressive results compared to those he covers for other cancers.

Feel good and keep smiling! Pat

BREAKING NEWS: Japan approves use of Onyx metastatic colorectal cancer drug six months after FDA does the same here in U.S.

noreply@blogger.com (Pat and Pattie Killingsworth) — Tue, 26 Mar 2013 12:56:00 +0000

I wouldn't normally share news like this on CancerNews.US. Not because it isn't important--it is--but because it isn't flashy. Onyx Pharmaceuticals manufacturers a new multiple myeloma (bone cancer) drug so I have contacts at the company. I was going to disregard it, until I realized it could be very instructional. Note very little information about how effective Stivarga is, but lots of information about possible side effects and complications.

Such is the world we live in. In the world of chemotherapy, the medicine can end-up being worse than the cancer.

The Pharma Times' Selina McCee reported this one hour ago:

Bayer's Stivarga has been approved for the treatment of patients with unresectable, advanced/recurrent CRC, after data from the pivotal Phase III CORRECT study showed a statistically significant improvement in overall survival and progression-free survival compared to placebo in patients whose disease had progressed despite prior treatment.

What does "significant improvement" mean? According to the FDA, in this case:

Results showed patients who took Stivarga had a delay in tumor growth (progression-free survival) that was, on average, 3.9 months later than patients who were given placebo.

The FDA approved Stivarga's use last September here in the U.S. I have no agenda here. But as a cancer patient, this news--and these numbers--don't exactly leave me feeling all warm and fuzzy. Check-out the list of possible complications in the press release below and draw your own conclusions.

Bayer's Stivarga(R) (regorafenib) Tablets Approved in Japan

WAYNE, NJ and SOUTH SAN FRANCISCO, CA--(Marketwire - March 25, 2013) - Bayer HealthCare and Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) announced today that the Ministry of Health, Labor and Welfare (MHLW) in Japan has approved Stivarga® (regorafenib) tablets for the treatment of patients with metastatic colorectal cancer (mCRC).

In September 2012, Stivarga was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. It was approved by the U.S. FDA for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate in February 2013.

Stivarga is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the United States. In 2011, Bayer entered into an agreement with Onyx, under which Onyx receives a royalty on all global net sales of Stivarga in oncology.

The approval of Stivarga by the MHLW is based on data from the international multicenter pivotal Phase III CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial which evaluated regorafenib plus best supportive care (BSC) versus placebo plus BSC in patients with mCRC, whose disease has progressed after approved standard therapies. The CORRECT study included 20 sites in Japan.

About Stivarga (regorafenib)
In the United States, Stivarga is indicated for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. It is also indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.

Stivarga is an inhibitor of multiple kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, and maintenance of the tumor microenvironment.(1)
For full U.S. prescribing information, including BOXED WARNING, visit www.stivarga-us.com.

Important U.S. Safety Information for Stivarga® (regorafenib) Tablets

WARNING: HEPATOTOXICITY

Severe and sometimes fatal hepatotoxicity has been observed in clinical trials.
Monitor hepatic function prior to and during treatment.
Interrupt and then reduce or discontinue STIVARGA for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence.

Severe drug-induced liver injury with fatal outcome occurred in 0.3% of 1200 STIVARGA-treated patients across all clinical trials. In metastatic colorectal cancer (mCRC), fatal hepatic failure occurred in 1.6% of patients in the STIVARGA arm and in 0.4% of patients in the placebo arm; all the patients with hepatic failure had metastatic disease in the liver. In gastrointestinal stromal tumor (GIST), fatal hepatic failure occurred in 0.8% of patients in the STIVARGA arm.

Obtain liver function tests (ALT, AST, and bilirubin) before initiation of STIVARGA and monitor at least every 2 weeks during the first 2 months of treatment. Thereafter, monitor monthly or more frequently as clinically indicated. Monitor liver function tests weekly in patients experiencing elevated liver function tests until improvement to less than 3 times the upper limit of normal (ULN) or baseline values. Temporarily hold and then reduce or permanently discontinue STIVARGA, depending on the severity and persistence of hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis.

STIVARGA caused an increased incidence of hemorrhage. The overall incidence (Grades 1-5) was 21% and 11% with STIVARGA vs 8% and 3% with placebo in mCRC and GIST patients, respectively. Fatal hemorrhage occurred in 4 of 632 (0.6%) STIVARGA-treated patients and involved the respiratory, gastrointestinal, or genitourinary tracts. Permanently discontinue STIVARGA in patients with severe or life-threatening hemorrhage and monitor INR levels more frequently in patients receiving warfarin.

STIVARGA caused an increased incidence of hand-foot skin reaction (HFSR) (also known as palmar-plantar erythrodysesthesia [PPE]) and severe rash, frequently requiring dose modification. The overall incidence was 45% and 67% with STIVARGA vs 7% and 12% with placebo in mCRC and GIST patients, respectively. Incidence of Grade 3 HFSR (17% vs 0% in mCRC and 22% vs 0% in GIST), Grade 3 rash (6% vs < 1% in mCRC and 7% vs 0% in GIST), serious adverse reactions of erythema multiforme (0.2% vs 0% in mCRC), and Stevens-Johnson syndrome (0.2% vs 0% in mCRC) was higher in STIVARGA-treated patients. Toxic epidermal necrolysis occurred in 0.17% of 1200 STIVARGA-treated patients across all clinical trials. Withhold STIVARGA, reduce the dose, or permanently discontinue depending on the severity and persistence of dermatologic toxicity.

STIVARGA caused an increased incidence of hypertension (30% vs 8% in mCRC and 59% vs 27% in GIST with STIVARGA vs placebo, respectively). Hypertensive crisis occurred in 0.25% of 1200 STIVARGA-treated patients across all clinical trials. Do not initiate STIVARGA until blood pressure is adequately controlled. Monitor blood pressure weekly for the first 6 weeks of treatment and then every cycle, or more frequently, as clinically indicated. Temporarily or permanently withhold STIVARGA for severe or uncontrolled hypertension.

STIVARGA increased the incidence of myocardial ischemia and infarction (1.2% with STIVARGA vs 0.4% with placebo). Withhold STIVARGA in patients who develop new or acute cardiac ischemia or infarction, and resume only after resolution of acute cardiac ischemic events if the potential benefits outweigh the risks of further cardiac ischemia.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS) occurred in 1 of 1200 STIVARGA-treated patients across all clinical trials. Confirm the diagnosis of RPLS with MRI and discontinue STIVARGA in patients who develop RPLS.

Gastrointestinal perforation or fistula occurred in 0.6% of 1200 patients treated with STIVARGA across clinical trials. In GIST, 2.1% (4/188) of STIVARGA-treated patients developed gastrointestinal fistula or perforation: of these, 2 cases of gastrointestinal perforation were fatal. Permanently discontinue STIVARGA in patients who develop gastrointestinal perforation or fistula.

Treatment with STIVARGA should be stopped at least 2 weeks prior to scheduled surgery. Resuming treatment after surgery should be based on clinical judgment of adequate wound healing. STIVARGA should be discontinued in patients with wound dehiscence.

STIVARGA can cause fetal harm when administered to a pregnant woman. Use effective contraception during treatment and up to 2 months after completion of therapy. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from STIVARGA, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

The most frequently observed adverse drug reactions ( ≥ 30%) in STIVARGA-treated patients vs placebo-treated patients in mCRC, respectively, were: asthenia/fatigue (64% vs 46%), decreased appetite and food intake (47% vs 28%), HFSR/PPE (45% vs 7%), diarrhea (43% vs 17%), mucositis (33% vs 5%), weight loss (32% vs 10%), infection (31% vs 17%), hypertension (30% vs 8%), and dysphonia (30% vs 6%).
The most frequently observed adverse drug reactions ( ≥ 30%) in STIVARGA-treated patients vs placebo-treated patients in GIST, respectively, were: HFSR/PPE (67% vs 15%), hypertension (59% vs 27%), asthenia/fatigue (52% vs 39%), diarrhea (47% vs 9%), mucositis (40% vs 8%), dysphonia (39% vs 9%), infection (32% vs 5%), decreased appetite and food intake (31% vs 21%), and rash (30% vs 3%).

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer's oncology franchise now includes two oncology products and several other compounds in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

About Onyx Pharmaceuticals, Inc.
Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com.
STIVARGA® is a trademark of Bayer®. Bayer® and the Bayer Cross® are registered trademarks of Bayer.

Forward-Looking Statement
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

This news release contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include, without limitation, statements regarding results of clinical development, regulatory processes, safety and commercial potential of Stivarga (regorafenib). These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: competition; failures or delays in clinical trials or the regulatory process; Onyx or Bayer, as the case may be, may be unsuccessful in launching, maintaining adequate supply of or obtaining reimbursement for Stivarga; market acceptance and the rate of adoption of Stivarga; pharmaceutical pricing and reimbursement pressures; serious adverse side effects, if they are associated with Stivarga; and government regulation; Reference should be made to Onyx's Annual Report on Form 10-K for the year ended December 31, 2011 filed with the Securities and Exchange Commission, as updated by Onyx's subsequent Quarterly Reports on Form 10-Q, under the heading "Risk Factors" for a more detailed description of these and other risks. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.
References:

1. STIVARGA U.S. Prescribing Information, February 2013.

I write about taking "baby steps" in oncology. Seems to me these are "baby, baby steps."

Feel good and keep smiling! Pat

Fox News Update:

noreply@blogger.com (Pat and Pattie Killingsworth) — Sun, 17 Mar 2013 00:55:00 +0000

I ran a feature about Brooke's unexpected cancer diagnosis a while back. Click on the headline link below for an update about her condition:

Brooke Burke-Charvet: How I beat cancer

Glad she feels like she has beaten her cancer. I might wait a few years before making that proclamation, but makes for good PR and hopefully she won't dwell on it as much now.

Feel good and keep smiling - she is! Pat

New drug helps doctors locate cancerous lymph nodes that were previously undetectable...

noreply@blogger.com (Pat and Pattie Killingsworth) — Wed, 13 Mar 2013 22:58:00 +0000

I haven't been keeping-up with my celebrity and main stream media focus of this site lately. I have several other sites more specifically targeted toward bone marrow cancer (multiple myeloma) and cancer lifestyle choices.

But this is big news! A small story, but the implications are large indeed. More accurate biopsies will help cancer patients in so many ways. Click-on the headline link below to read this short, informative USA Today article about a new imaging process that targets the lymph nodes:

FDA approves imaging drug for cancer lymph nodes

Pretty amazing! Anything that increases accuracy for surgeons doing biopsies is a good thing.

Feel good and keep smiling! Pat

GIST stands for gastrointestinal stromal tumor. Details about new FDA aproval below:

noreply@blogger.com (Pat and Pattie Killingsworth) — Mon, 25 Feb 2013 21:39:00 +0000

FOR IMMEDIATE RELEASE

Bayer's Stivarga(R) (regorafenib) Tablets Approved by U.S. FDA for Treatment of Patients With Locally Advanced, Unresectable or Metastatic GIST

WAYNE, NJ and SOUTH SAN FRANCISCO, CA--(Marketwire - February 25, 2013) - Bayer HealthCare and Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) announced today that the U.S. Food and Drug Administration (FDA) approved Bayer's Stivarga® (regorafenib) tablets to treat patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.(1) Stivarga was approved by the FDA in September 2012 for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.(1)

"The FDA's decision marks the second approval for Stivarga -- first in metastatic colorectal cancer last year and now in locally advanced, unresectable or metastatic GIST, where there is a high unmet medical need for patients who have exhausted all approved treatment options," said Pamela A. Cyrus, MD, Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "These regulatory milestones underscore Bayer's commitment to deliver effective products for difficult-to-treat cancers."

Stivarga is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the United States. In 2011, Bayer entered into an agreement with Onyx, under which Onyx receives a royalty on all global net sales of Stivarga in oncology.

The approval of Stivarga in GIST is based on data from the pivotal Phase III GRID (GIST - Regorafenib In Progressive Disease) trial, which showed that Stivarga plus best supportive care (BSC) statistically significantly improved progression-free survival (PFS) compared to placebo plus BSC (HR=0.27 [95% CI 0.19-0.39], p<0.0001) in patients with locally advanced, unresectable or metastatic GIST who have been previously treated with imatinib mesylate and sunitinib malate.(1) The median PFS was 4.8 months in the Stivarga arm versus 0.9 months in the placebo arm (p<0.0001). There was no statistically significant difference in overall survival at the time of the planned interim analysis based on 29% of the total events for the final analysis. At the time of disease progression as assessed by central review, the study blind was broken and all patients were offered the opportunity to take Stivarga at the investigator's discretion. Fifty-six (85%) patients randomized to placebo and 41 (31%) patients randomized to Stivarga received open-label Stivarga.(1)

The most frequently observed adverse drug reactions (≥30%) in Stivarga-treated patients vs. placebo-treated patients in GIST, respectively, were: hand-foot skin reaction (HFSR) / palmar-plantar erythrodysesthesia (PPE), hypertension, asthenia/fatigue, diarrhea, mucositis, dysphonia, infection, decreased appetite and food intake, and rash. The Stivarga label includes a boxed warning citing the risk of hepatotoxicity. Severe and sometimes fatal hepatotoxicity has been observed in clinical trials.(1)
"While great progress has been made in the treatment of GIST since the introduction of kinase inhibitors as effective therapies for this orphan disease, we have been looking for additional, effective treatments for GIST patients whose disease worsens despite currently approved therapies," said George D. Demetri, MD, Principal Investigator of the GRID study and Director of the Center for Sarcoma and Bone Oncology at the Dana-Farber Cancer Institute in Boston, MA. "These data show that regorafenib can slow disease progression in patients who are no longer responding to other approved therapies and may provide another avenue for GIST patients who would otherwise have no FDA-approved treatment option."

About Gastrointestinal Stromal Tumor (GIST)
GIST is the most common form of sarcoma (a type of cancer that develops from certain tissues, like bone or muscle) involving the gastrointestinal tract.(2) In the United States, it is estimated that there are approximately 4,000-5,000 new cases of GIST diagnosed each year, of which about 1,500 have already metastasized at diagnosis.(2,3) GIST may not cause any symptoms and may be found incidentally when the doctor is looking for other problems.(3)

About the GRID Study
GRID was a randomized, double-blind, placebo-controlled, multi-center, cross-over Phase III study of regorafenib for the treatment of GIST. It randomized 199 patients who had been previously treated with imatinib mesylate and sunitinib malate. Patients were randomized in a 2:1 ratio to receive either regorafenib plus BSC or placebo plus BSC to evaluate efficacy and safety. Treatment cycles consisted of 160 mg regorafenib (or matching placebo) once daily for three weeks on / one week off plus BSC. Patients continued therapy until disease progression or unacceptable toxicity. The primary endpoint was PFS, and the key secondary outcome measure was OS. The safety and tolerability of the two treatment groups were also compared.(4)

About Stivarga (regorafenib)
Stivarga is indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.1 It is also indicated for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.(1)

Stivarga is an inhibitor of multiple kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, and maintenance of the tumor microenvironment.(1)

Stivarga was developed under the Fast Track program and received priority review designations for locally advanced, unresectable or metastatic GIST and mCRC from the FDA. These designations are granted by the FDA to expedite the development and review of drugs to treat serious diseases and fill an unmet medical need (fast track), and given to drugs that provide a treatment where no adequate therapy exists (priority review).

For full prescribing information, including BOXED WARNING, visit www.stivarga-us.com. Bayer offers patient assistance through the Bayer REACH® (Resources for Expert Assistance and Care Helpline) program. Patients may contact the REACH Program at 1-866-639-2827 for additional information.

WARNING: HEPATOTOXICITY

Severe and sometimes fatal hepatotoxicity has been observed in clinical trials.
Monitor hepatic function prior to and during treatment.
Interrupt and then reduce or discontinue STIVARGA for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence.

Severe drug-induced liver injury with fatal outcome occurred in 0.3% of 1200 STIVARGA-treated patients across all clinical trials. In metastatic colorectal cancer (mCRC), fatal hepatic failure occurred in 1.6% of patients in the STIVARGA arm and in 0.4% of patients in the placebo arm; all the patients with hepatic failure had metastatic disease in the liver. In gastrointestinal stromal tumor (GIST), fatal hepatic failure occurred in 0.8% of patients in the STIVARGA arm.

Obtain liver function tests (ALT, AST, and bilirubin) before initiation of STIVARGA and monitor at least every 2 weeks during the first 2 months of treatment. Thereafter, monitor monthly or more frequently as clinically indicated. Monitor liver function tests weekly in patients experiencing elevated liver function tests until improvement to less than 3 times the upper limit of normal (ULN) or baseline values. Temporarily hold and then reduce or permanently discontinue STIVARGA, depending on the severity and persistence of hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis.

STIVARGA caused an increased incidence of hemorrhage. The overall incidence (Grades 1-5) was 21% and 11% with STIVARGA vs 8% and 3% with placebo in mCRC and GIST patients, respectively. Fatal hemorrhage occurred in 4 of 632 (0.6%) STIVARGA-treated patients and involved the respiratory, gastrointestinal, or genitourinary tracts. Permanently discontinue STIVARGA in patients with severe or life-threatening hemorrhage and monitor INR levels more frequently in patients receiving warfarin.
STIVARGA caused an increased incidence of hand-foot skin reaction (HFSR) (also known as palmar-plantar erythrodysesthesia [PPE]) and severe rash, frequently requiring dose modification. The overall incidence was 45% and 67% with STIVARGA vs 7% and 12% with placebo in mCRC and GIST patients, respectively. Incidence of Grade 3 HFSR (17% vs 0% in mCRC and 22% vs 0% in GIST), Grade 3 rash (6% vs <1% in mCRC and 7% vs 0% in GIST), serious adverse reactions of erythema multiforme (0.2% vs 0% in mCRC), and Stevens-Johnson syndrome (0.2% vs 0% in mCRC) was higher in STIVARGA-treated patients. Toxic epidermal necrolysis occurred in 0.17% of 1200 STIVARGA-treated patients across all clinical trials. Withhold STIVARGA, reduce the dose, or permanently discontinue depending on the severity and persistence of dermatologic toxicity.

STIVARGA caused an increased incidence of hypertension (30% vs 8% in mCRC and 59% vs 27% in GIST with STIVARGA vs placebo, respectively). Hypertensive crisis occurred in 0.25% of 1200 STIVARGA-treated patients across all clinical trials. Do not initiate STIVARGA until blood pressure is adequately controlled. Monitor blood pressure weekly for the first 6 weeks of treatment and then every cycle, or more frequently, as clinically indicated. Temporarily or permanently withhold STIVARGA for severe or uncontrolled hypertension.

STIVARGA increased the incidence of myocardial ischemia and infarction (1.2% with STIVARGA vs 0.4% with placebo). Withhold STIVARGA in patients who develop new or acute cardiac ischemia or infarction, and resume only after resolution of acute cardiac ischemic events if the potential benefits outweigh the risks of further cardiac ischemia.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS) occurred in 1 of 1200 STIVARGA-treated patients across all clinical trials. Confirm the diagnosis of RPLS with MRI and discontinue STIVARGA in patients who develop RPLS.

Gastrointestinal perforation or fistula occurred in 0.6% of 1200 patients treated with STIVARGA across clinical trials. In GIST, 2.1% (4/188) of STIVARGA-treated patients developed gastrointestinal fistula or perforation: of these, 2 cases of gastrointestinal perforation were fatal. Permanently discontinue STIVARGA in patients who develop gastrointestinal perforation or fistula.

Treatment with STIVARGA should be stopped at least 2 weeks prior to scheduled surgery. Resuming treatment after surgery should be based on clinical judgment of adequate wound healing. STIVARGA should be discontinued in patients with wound dehiscence.

STIVARGA can cause fetal harm when administered to a pregnant woman. Use effective contraception during treatment and up to 2 months after completion of therapy. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from STIVARGA, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

The most frequently observed adverse drug reactions (≥30%) in STIVARGA-treated patients vs placebo-treated patients in mCRC, respectively, were: asthenia/fatigue (64% vs 46%), decreased appetite and food intake (47% vs 28%), HFSR/PPE (45% vs 7%), diarrhea (43% vs 17%), mucositis (33% vs 5%), weight loss (32% vs 10%), infection (31% vs 17%), hypertension (30% vs 8%), and dysphonia (30% vs 6%).
The most frequently observed adverse drug reactions (≥30%) in STIVARGA-treated patients vs placebo-treated patients in GIST, respectively, were: HFSR/PPE (67% vs 15%), hypertension (59% vs 27%), asthenia/fatigue (52% vs 39%), diarrhea (47% vs 9%), mucositis (40% vs 8%), dysphonia (39% vs 9%), infection (32% vs 5%), decreased appetite and food intake (31% vs 21%), and rash (30% vs 3%).

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer's oncology franchise now includes two oncology products and several other compounds in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes novel targets and pathways with the potential to transform the way that cancer is treated across tumor types and stages of disease.

About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

About Onyx Pharmaceuticals, Inc.
Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com.
STIVARGA® is a trademark of Bayer®. Bayer® and the Bayer Cross® are registered trademarks of Bayer.

Forward-Looking Statement
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

This news release contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include, without limitation, statements regarding results of clinical development, regulatory processes, safety and commercial potential of Stivarga (regorafenib). These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: competition; failures or delays in clinical trials or the regulatory process; Onyx or Bayer, as the case may be, may be unsuccessful in launching, maintaining adequate supply of or obtaining reimbursement for Stivarga; market acceptance and the rate of adoption of Stivarga; pharmaceutical pricing and reimbursement pressures; serious adverse side effects, if they are associated with Stivarga; and government regulation; Reference should be made to Onyx's Annual Report on Form 10-K for the year ended December 31, 2011 filed with the Securities and Exchange Commission, as updated by Onyx's subsequent Quarterly Reports on Form 10-Q, under the heading "Risk Factors" for a more detailed description of these and other risks. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.

References:

1.  STIVARGA Prescribing Information, February 2013. 
2.  Joensuu H. Gastrointestinal stromal tumor (GIST). Annals of Oncology.
    2006 September; Volume 17. Available at
    http://annonc.oxfordjournals.org/content/17/suppl_10/x280.full.pdf+h
    tml . Accessed October 19, 2012. 
3.  American Cancer Society. Gastrointestinal Stromal Tumor (GIST). (Last
    Revised 2/1/2012). Available at
    http://www.cancer.org/acs/groups/cid/documents/webcontent/003103-
    pdf.pdf. Accessed October 12, 2012. 
4.  Casali, et al. Clinical benefit with regorafenib across subgroups and
    post progression in patients with advanced gastrointestinal stromal
    tumors (GIST) after progression on imatinib (IM) and sunitinib (SU):
    Phase III GRID trial update. 2012 European Society of Medical Oncology;
    September, 2012. Vienna, Austria.

This is encouraging news. Not a cure, but every little bit helps. Click-on headline link below to read all about it...

noreply@blogger.com (Pat and Pattie Killingsworth) — Mon, 25 Feb 2013 00:45:00 +0000

FDA Approves T-DM1 (Kadcyla) for HER2-Positive Breast Cancer

Cancer takes another wealthy celebrity. More proof that money can't guarantee victory over cancer...

noreply@blogger.com (Pat and Pattie Killingsworth) — Mon, 18 Feb 2013 23:12:00 +0000

LOS ANGELES (AP)

Jerry Buss, the Los Angeles Lakers' playboy owner who shepherded the NBA team to 10 championships from the Showtime dynasty of the 1980s to the Kobe Bryant era, died Monday (from an undisclosed form of cancer). He was 80.

He died at Cedars-Sinai Medical Center in Los Angeles, said Bob Steiner, his assistant.
Buss had been hospitalized for most of the past 18 months while undergoing cancer treatment, but the immediate cause of death was kidney failure, Steiner said. With his condition worsening in recent weeks, several prominent former Lakers visited Buss to say goodbye.

''The NBA has lost a visionary owner whose influence on our league is incalculable and will be felt for decades to come,'' NBA Commissioner David Stern said. ''More importantly, we have lost a dear and valued friend.''

Under Buss' leadership since 1979, the Lakers became Southern California's most beloved sports franchise and a worldwide extension of Hollywood glamour. Buss acquired, nurtured and befriended a staggering array of talented players and basketball minds during his Hall of Fame tenure, from Magic Johnson and Kareem Abdul-Jabbar to Bryant, Shaquille O'Neal and Dwight Howard.

''He was a great man and an incredible friend,'' Johnson tweeted.

Few owners in sports history can approach Buss' accomplishments with the Lakers, who made the NBA finals 16 times during his nearly 34 years in charge, winning 10 titles between 1980 and 2010. With 1,786 victories, the Lakers easily are the NBA's winningest franchise since he bought the club, which is now run largely by Jim Buss and Jeanie Buss, two of his six children.

''We not only have lost our cherished father, but a beloved man of our community and a person respected by the world basketball community,'' the Buss family said in a statement issued by the Lakers.

''It was our father's often-stated desire and expectation that the Lakers remain in the Buss family. The Lakers have been our lives as well, and we will honor his wish and do everything in our power to continue his unparalleled legacy.''

JERRY BUSS: 1933-2013

Hall of Fame owner of Lakers dies. See his career in photos.

Buss always referred to the Lakers as his extended family, and his players rewarded his fanlike excitement with devotion, friendship and two hands full of championship rings. Working with front-office executives Jerry West, Bill Sharman and Mitch Kupchak, Buss spent lavishly to win his titles despite lacking a huge personal fortune, often running the NBA's highest payroll while also paying high-profile coaches Pat Riley and Phil Jackson.

Always an innovative businessman, Buss paid for the Lakers through both their wild success and his own groundbreaking moves to raise revenue. He co-founded a basic-cable sports television network and sold the naming rights to the Forum at times when both now-standard strategies were unusual, further justifying his induction to the Pro Basketball Hall of Fame in 2010.

Buss was a ''cornerstone of the Los Angeles sports community and his name will always be synonymous with his beloved Lakers,'' Los Angeles Mayor Antonio Villaraigosa said. ''It was through his stewardship that the Lakers brought `Showtime' basketball and numerous championship rings to this great city. Today we mourn the loss and celebrate the life of a man who helped shape the modern landscape of sports in L.A.''

Clinton-era law forbids legally married wife from receiving the survivor benefits other military widows get following breast cancer death

noreply@blogger.com (Pat and Pattie Killingsworth) — Mon, 11 Feb 2013 17:03:00 +0000

What an unfortunate story! Too bad its only one example of hundreds that occur yearly. Click-on the headline link below and read this heart-wrenching Washington Post feature:

Soldier dies of breast cancer, but her widow won’t get benefits

Posted by Andrea Stone on February 10, 2013

Check-out these CBS News reports about cancer: Consumer Reports disses cancer screening and statistically, lumpectomy just as or more effective than mastectomy. Click-on headline links below to access video clips:

noreply@blogger.com (Pat and Pattie Killingsworth) — Thu, 31 Jan 2013 22:26:00 +0000

Most cancer tests should be avoided: Consumer Reports

A new study by Consumer Reports on cancer tests reveals that most should be avoided. Dr. John Santa, of Consumer Reports, discusses the new study with the "CBS This Morning" co-hosts.

Lumpectomy tops mastectomy in cancer treatment study

A study in the journal "Cancer" has found that women are 14 percent less likely to die from breast cancer after undergoing a lumpectomy followed by radiation treatment than after a mastectomy. Dr. Jon LaPook reports.

Exciting advance in breast cancer testing could help save lives

noreply@blogger.com (Pat and Pattie Killingsworth) — Wed, 23 Jan 2013 18:30:00 +0000

This is BIG NEWS! If docs could predict which patients are most likely to relapse and when, lives could be extended and saved. Check-out this article in Medical News Today:

Breast Cancer Recurrence Predictable With Blood Test

Using a DNA marker that can be obtained via a blood test, researchers in Canada were able accurately to predict which women were more likely to see a recurrence of their breast cancer years later. Although more studies are needed to confirm their findings, they suggest they could complement current prognosis approaches based on tumor assessment.

Sambasivarao Damaraju, a professor with the Faculty of Medicine and Dentistry at Canada's University of Alberta, and colleagues, write about their findings in the 16 January issue of the open access online journal PLoS ONE.

Current Prognoses Methods Based on Tumor Assessment

Damaraju says in a statement that while some breast cancer patients receive an excellent prognosis, the cancer still comes back. And other patients remain cancer free, even though they receive a poor prognosis.

This is because, as he and his colleagues note in their study background, current breast cancer recurrence prognoses use tumor-based assessments, which they describe as "not optimal determinants" of the risk of breast cancer recurrence.

For their study, Damaraju and colleagues focused on good prognosis breast cancer: that which has a high success rate in terms of initial recovery and treatment. Around 70% of breast cancers fall into this category.

But, although initial treatment succeeds, there are still substantial deaths due to cancer spread in this group. Damaraju and colleagues suggest this is because so many receive a good prognosis.

DNA Marker Combined with Tumor-Based Markers Would Improve Accuracy of Diagnoses

Damaraju says the accuracy of tumor-based markers could be improved if combined with their DNA marker method, which can be assessed from a simple blood test.

Currently, treatment options are based on what doctors find about the tumor: such as the size, grade and what markers are present or not in the tissue.

But Damaraju says:

"If we can accurately predict which women are at high risk of breast cancer recurrence, it gives the physicians and oncologists treating those women time to design a more aggressive therapy in hopes of preventing the cancer from coming back."

"Treatment strategies could be tailor made for these women based on their genetic make-up and how susceptible it makes them to breast cancer recurrence," he adds...

Read more by clicking-on this link: http://www.medicalnewstoday.com/articles/255233.php

Progress! Feel good and keep smiling! Pat

I just wrote a post about a great new anti-cancer nutrition iPhone app on one of my other websites. But according to CBS news, new technology like this doesn't always work. Click-on the headline link below to read all about it:

noreply@blogger.com (Pat and Pattie Killingsworth) — Fri, 18 Jan 2013 04:48:00 +0000

Skin cancer-detecting smartphone apps may not be accurate

And here's a link to the other article I mentioned above:

The Anti Cancer Diet: Nutrition and Cancer

A major cancer hospital has a new iPhone app that will help you fight cancer with the foods you eat.

Always great to read a real "feel good" story. Check-out this excerpt about a miraculous brain cancer recovery...

noreply@blogger.com (Pat and Pattie Killingsworth) — Wed, 09 Jan 2013 14:31:00 +0000

Mom Stuns Doctors, Beats Deadliest Brain Cancer

ABC NEWS

Click-on headline link below to learn about NFL coach's emotional leukemia battle...

noreply@blogger.com (Pat and Pattie Killingsworth) — Mon, 31 Dec 2012 03:08:00 +0000

Colts' Pagano talks cancer, in excruciating detail

Indianapolis Colts coach Chuck Pagano recounts his journey as a cancer patient this fall

This type of thing is more common than one might think. Click-on the headline link below to watch the ABC News report or to read all about it:

noreply@blogger.com (Pat and Pattie Killingsworth) — Sat, 29 Dec 2012 18:03:00 +0000

Cancer Drug Shortage Leads to Less-Effective Substitute Drugs, Study Finds

Abby Alonzo was eight weeks into treatment for Hodgkin lymphoma and doing great when her doctor informed the 9-year-old's parents that one ingredient in the cocktail of chemo drugs she was receiving was no longer available, and they would have to use a substitution.

"It's scary, and I was alarmed but I didn't really have a sense of how critical this drug was," said Katie Alonzo, Abby's mother. "When something like this happens, you have to put your faith in the doctors."
But by 12 weeks into treatment, Abby relapsed. Rather than receiving a planned break from treatment, she was rushed into emergency "salvage therapy," which involved more chemo, a bone marrow transplant and radiation.

The doctors at St. Jude Children's Research Hospital in Memphis, Tenn., who treated Abby, attribute her relapse to the shortage of the drug mechlorethamine, also known as nitrogen mustard. In today's New England Journal of Medicine, the St. Jude doctors, along with colleagues from the Dana-Farber cancer institute in Boston and the Lucile Packard Children's Hospital in Stanford, Calif., highlight how the scarcity of this medication has been linked to a higher rate of relapse among children, teenagers and young adults with Hodgkin lymphoma.

The 40 patients in the study who received the substitute drug cyclophosphamide experienced complications at about twice the rate of the 181 patients studied who didn't have to switch drugs. This is the first randomized study to compare the differences in treatment outcomes between the two medications.
None of the patients died, but the authors emphasize that they're only 18 months out from treatment and could still be hit with adverse effects...

Click-on the headline link above to read more.

Feel good and keep smiling! Pat

Indianapolis coach back on sidelines following 3 months of chemotherapy

noreply@blogger.com (Pat and Pattie Killingsworth) — Fri, 28 Dec 2012 18:37:00 +0000

Pagano Back to Coach Colts After Cancer Treatment

MICHAEL MAROT - AP Sports Writer

INDIANAPOLIS December 24, 2012

Chuck Pagano stepped to the podium Monday, hugged his team owner, thanked his family for its support and wiped a tear from his eye.

He might, finally, turn out the lights in his office, too.

Nearly three months to the day after being diagnosed with leukemia, the Colts' first-year coach returned to a team eager to reunite with a boss healthy enough to go back to work.

"I told you my best day of my life was July 1, 1989," Pagano said, referring to his wedding date. "Today was No. 2. Getting to pull up, drive in, get out of my car, the key fob still worked. I was beginning to question whether it would or not. When I asked for Bruce to take over, I asked for him to kick some you-know-what and to do great. Damn Bruce, you had to go and win nine games? Tough act to follow. Tough act to follow. Best in the history of the NFL. That's what I have to come back to."

The comment turned tears into the laughter everyone expected on such a festive occasion.

For Pagano and the Colts, Monday morning was as precious as anyone could have imagined when Pagano took an indefinite leave to face the biggest opponent of his life, cancer.

In his absence, all the Colts was win nine of 12 games, make a historic turnaround and clinch a playoff spot all before Sunday's regular-season finale against Houston, which they pegged as the day they hoped to have Pagano back. If all goes well at practice this week, Pagano will be on the sideline for the first time since a Week 3 loss to Jacksonville...

There is much more. CLICK HERE to access the rest of the article.

As a former high school football coach and blood cancer survivor, this is a very exciting and inspirational story for me. Looking toward a possible Green Bay/Indianapolis rematch in this year's Super Bowl...

Feel good and keep smiling! Pat

Not unusual for a man of Governor's Brown age to develop prostate cancer. Click-on the headline link below to read all about it:

noreply@blogger.com (Pat and Pattie Killingsworth) — Mon, 17 Dec 2012 20:43:00 +0000

Gov. Jerry Brown Undergoing Treatment for Prostate Cancer - AP

BREAKING NEWS: New combo therapy gives hope to older acute myeloid leukemia (AML). Here's the press release announcing data from here in Atlanta at ASH. I have been here since Thursday, mostly focusing on multiple meyloma. But this is an example of the type of incremental progress researchers are making with blood cancers

noreply@blogger.com (Pat and Pattie Killingsworth) — Tue, 11 Dec 2012 04:29:00 +0000

REVLIMID^® AND VIDAZA^® COMBINATION THERAPY ACHIEVES NEARLY 30 PERCENT COMPLETE RESPONSE IN UNTREATED ELDERLY PATIENTS WITH ACUTE MYELOID LEUKEMIA

BOUDRY, SWITZERLAND – (Dec. 10, 2012) – Celgene International Sàrl (NASDAQ: CELG) today announced that results from a study evaluating the combination of REVLIMID (lenalidomide) plus VIDAZA (azacitidine) in patients 60 years or older with untreated acute myeloid leukemia (AML) were presented at the American Society of Hematology annual meeting in Atlanta, GA.

In the phase II investigator-initiated study, patients received azacitidine 75 mg/m²/day, days 1-7 followed by lenalidomide 50 mg/day, days 8-28 of 42-day cycles. Treatment was continued until disease progression, unacceptable adverse event or completion of 12 cycles.

With 42 patients enrolled in the study, the overall response rate was 41%, with 28% of patients achieving a complete response (CR/CRi). The median time to CR and CRi was 12 and 6 weeks, respectively; the median duration of response (CR/CRi/PR) was 28 weeks (range 6 to >104 weeks). Median overall survival for all patients in the study was 20 weeks (range 1 to >121 weeks) and 69 weeks (range 10 to >121 weeks) for patients who responded to therapy. Additionally, median overall survival for responders was superior to non-responders (69 vs. 15 weeks p<0.01).

Most common adverse events were grade 1-2 and gastrointestinal in nature. There was one case each of grade 3 fever, sepsis, hyponatremia, pneumonitis and SIRS syndrome.

A three-arm phase II study in elderly AML patients is currently underway evaluating azacitidine monotherapy, azacitidine followed by lenalidomide (50 mg), and lenalidomide monotherapy.

These data are from an investigational study. REVLIMID^® plus VIDAZA^® is not approved for the treatment of acute myeloid leukemia.

Click-on headline link below for AP/NPR report about President Hugo Chavez' cancer relapse...

noreply@blogger.com (Pat and Pattie Killingsworth) — Mon, 10 Dec 2012 02:12:00 +0000

Hugo Chavez Says His Cancer Has Returned

This could be big, big news in the world of cancer research...

noreply@blogger.com (Pat and Pattie Killingsworth) — Mon, 03 Dec 2012 14:26:00 +0000

Supreme Court to decide if human genes patentable

November 30, 2012|Jonathan Stempel | Reuters

(Reuters) - The Supreme Court on Friday agreed to decide whether human genes can be patented, a hotly contested issue with broad practical and ethical consequences for the future of gene-based medicine for millions of people worldwide.

The nation's highest court in a brief order agreed to review a case over whether Myriad Genetics Inc may patent two genes linked to hereditary breast and ovarian cancer.

In a 2-1 ruling on August 16, a panel of the U.S. Federal Circuit Court of Appeals in Washington, D.C., upheld the biotechnology company's right to patent "isolated" genes that account for most inherited forms of the two cancers.

That ruling also denied Myriad's effort to patent methods of "comparing" or "analyzing" DNA sequences.
The appeal against Myriad and the University of Utah Research Foundation was being pursued by a variety of medical associations and doctors, led by the Association for Molecular Pathology. Their case is being handled by lawyers for the American Civil Liberties Union.

Myriad shares fell as much as 9 percent after the Supreme Court agreed to hear the appeal and ended the trading session down $1.13, or 3.8 percent, at $28.72 on the Nasdaq.

PLANNING OF MEDICAL CARE
Sandra Park, a lawyer for the ACLU Women's Rights Project who worked on the appeal, in a phone interview called Friday's decision to take the case a "huge step" toward ensuring the provision of needed medical care and research and that patients can access their own genetic information.

She estimated that more than 4,000 of the roughly 22,000 genes in the human genome have U.S. patents.
"For many people, understanding their genetic risk of disease is crucial to planning medical care," she said. "People need to understand that risk so they can plan for screening and other major medical decisions with their doctors."

Supporters of Salt Lake City-based Myriad, in contrast, have said denying patent protection could slow advances in personalized medicine, which uses genetic tests to identify specific therapies for individual patients.

Peter Meldrum, Myriad's chief executive, said in a statement that the Supreme Court's ultimate decision could affect the providing of medical treatment to hundreds of millions of people. He said Myriad's own diagnostic test has helped nearly 1 million people learn about their risk of hereditary cancer.

"The discovery and development of pioneering diagnostics and therapeutics require a huge investment and our U.S. patent system is the engine that drives this innovation," he said.

Many outside groups supported the petitioners, including the AARP, the American Medical Association, the American Society of Human Genetics, the March of Dimes Foundation, the National Breast Cancer Foundation and several women's health groups.

"Some critics say it is unjust to give a company a monopoly over something as intrinsic to people's health as their genes," said Josephine Johnston, a research scholar at The Hastings Center, a independent bioethics research institute in Garrison, New York, who is not involved in the Myriad case.

Here's an excerpt from a fun and inspirational article I found on Boston.com:

noreply@blogger.com (Pat and Pattie Killingsworth) — Tue, 20 Nov 2012 20:44:00 +0000

Orangutan's chemotherapy treatment for cancer ends

In this undated photo provided by Jungle Island, the orangutan named Peanut, one of the star attractions at Jungle Island, is shown in Miami. Peanut had been undergoing chemotherapy since August after being diagnosed with non-Hodgkin lymphoma. Her doctors said Tuesday, Nov. 13, 2012 that they decided to stop treatments after three courses of combination chemo-immunotherapy. The team says since the disease was caught early on, they are confident Peanut received "an adequate course of therapy." (AP Photo/Jungle Island)

By SUZETTE LABOY

Associated Press / November 13, 2012

MIAMI (AP) — Peanut, an 8-year-old orangutan with cancer and one of the star attractions at Miami’s Jungle Island, no longer needs chemotherapy, her medical team announced Tuesday. Peanut had been undergoing chemotherapy since August, following a diagnosis of non-Hodgkin lymphoma. After three courses of combination chemo-immunotherapy, her doctors decided it was time to wrap up her treatments for the aggressive lymphoma. Although Peanut was not the first great ape to be treated for cancer like a human, experts said it is not common to use chemotherapy among orangutans.

Dr. Jason Chatfield, curator and staff veterinarian for Jungle Island, said the stress of ‘‘multiple immobilizations’’ for the treatment was a factor in a decision to end her chemotherapy. He added she received an adequate amount of chemotherapy.

‘‘What we do know is that without this chemotherapy, Peanut would not survive,’’ Chatfield said...

There's a lot more. CLICK HERE to access the rest of the article.

Feel good and keep smiling! Pat