June, 2006
ArchivesFDA approves Avastin for second-line colorectal cancer treatment
The FDA has approved Avastin™ (bevacizumab) in combination with chemotherapy as treatment for colorectal cancer that has progressed after initial treatment according to a news release from Genentech, Inc. on June 20, 2006.
Avastin™ was previously approved in February 2004 for first-line treatment in combination with 5FU-based chemotherapy.
Approval was based on results of a Phase III clinical trial conducted by the Eastern Oncology Cooperative Group that showed improved survival time when Avastin™ was added to FOLFOX4 chemotherapy. Patients receiving Avastin™ plus FOLFOX had a median survival of 12.4 months after beginning the second-line treatment compared to 10.7 months for patients on chemotherapy alone.
Posted by Kate Murphy on June 20th, 2006
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Erbitux will not be available in Canada due to conflicts over pricing.
Erbitux™ will not be marketed in Canada because of disagreements between the pharmaceutical distributor and the Canadian agency responsible for setting drug prices. Bristol-Myers Squibb Canada has decided not to launch Erbitux™ in Canada because it cannot agree on a price with the Patented Medicines Prices Review Board.
Use of Erbitux™ to treat colorectal cancer was approved by Health Canada in September of 2005.
The province of Ontario has approved payment for treatment with Erbitux™ in the United States for some patients, according to the June 19, 2006 Globe and Mail.
The Colorectal Cancer Association of Canada has spoken out on the lack of access to drugs to treat colorectal cancer in Canada. Drugs, such as Avastin™, Erbitux™, and Eloxatin™ have been approved by Health Canada but are not uniformly available across the nation because each province can choose whether or not to pay for the treatments. In some provinces, patients can have the drugs administered if they pay the cost of the medicines themselves.
Barry Stein, President of the Colorectal Cancer Association of Canada told Halifax Live.
"If we want to have an up to date health care system in the treatment of cancer in Canada we must not let this happen. Not only will we have unequal access to our health care system, but patients will be deprived of the medications due to cost restraints or the non introduction of new and novel therapies for the very same reasons.”
Erbitux™ (cetuximab) is used to treat patients with metastatic colorectal cancer whose cancer has gotten worse after initial treatments. It is approved for use in the United States and Europe alone and in combination with chemotherapy.
Posted by Kate Murphy on June 20th, 2006
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Poor women more likely to be diagnosed with with colorectal cancer after an emergency admission for obstruction or colon perforation
In some patients with colorectal cancer, the tumor is large enough to obstruct the colon or cause a bowel perforation. Obstruction or bowel perforation can result in emergency admission to the hospital and are usually a sign of advanced cancer. Low-income women are at greater risk for being diagnosed with colorectal cancer after bowel obstruction, perforation, or an emergency hospital admission.
Researchers led by Dr. Linda Raubeneck in Toronto reviewed health data from 1997 through 2001 in Ontario for all patients diagnosed with colorectal cancer, looking specifically at those who also had a diagnosis of bowel obstruction or perforation or who were diagnosed during an emergency hospital admission (OPE). During the time period about 41,000 people were diagnosed with colorectal cancer and 7,700 (19%) met the OPE criteria — obstruction, perforation or emergency admission.
Looking at risk factors that made OPE diagnosis more likely, Dr. Raubeneck’s team identified the following:
- Females
- Lower income
- Less likely to have had a colonoscopy or other bowel exam in the past five years
- Without a regular source of primary care
- Living in the urban Toronto area
A previous study by Dr. Raubeneck found that low income decreased the chances that an individual would have had a colonoscopy and that access to colonoscopy is better in rural than in urban areas of Ontario.
Expanding and targeting colorectal cancer screening programs are essential to reaching this group of women before cancer is advanced and cannot be successfully treated.
In conclusion, she writes
Among persons with a new diagnosis of CRC in Ontario, women and those who are poor are more likely to present with obstruction, perforation, or emergency admission to hospital. Population-based CRC screening is needed to address these adverse outcomes.
Raubeneck et. al. American Journal of Gastroenterology Volume 101 Issue 5 Page 1098 Date May 2006: Risk Factors for Obstruction, Perforation, or Emergency Admission at Presentation in Patients with Colorectal Cancer: A Population-Based Study
A detailed discussion of the Raubeneck study appears on Medscape.
Posted by Kate Murphy on June 14th, 2006
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Lamotrigrine does not appear to reduce severe peripheral neuropathy
INFORMATION FROM 2006 ASCO MEETING IN ATLANTA
Peripheral sensory neuropathy can be a serious side effect during treatment with some chemotherapies, including oxaliplatin which is now a standard therapy for both early stage and advanced colon cancer.
Lamotrigine or Lamictal is an anticonvulsant drug used to treat epilepsy. Researchers randomized patients with severe painful peripheral neuropathy to 10 weeks of lamotrigine or placebo to assess its ability to reduce pain and other neurotoxicity from chemotherapy. Patients were being treated with vinca alkaloids, taxanes, platinum agents, or combinations of neurotoxic drugs.
Neither pain nor neuropathy scores were significantly different between the treatment group who received lamotrigine and the placebo group. More lamotrigine patients (60%) discontinued therapy because of side effects than those on placebo (78%) and were less likely to complete all 10 weeks of therapy.
S.I. Renno and colleagues concluded:
These results suggest that lamotrigine is not effective for managing pain and symptoms due to CIPN.
ASCO 2006 Abstract 8530 — The efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy: A phase III randomized, double blind, placebo-controlled NCCTG trial, N01C3.
Posted by Kate Murphy on June 12th, 2006
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Conditional survival concept offers better prognostic information for patients and physicians
INFORMATION FROM THE 2006 ASCO MEETING IN ATLANTA
Although statistical chances for survival at 5 years are usually determined at the time of diagnosis, the reality is that prognosis improves the longer the patient lives. Rather looking at the initial risk, conditional survival gives patients and their doctors a more realistic view of life expectancy after a cancer diagnosis. Conditional survival improves over time.
Statisticians at the National Surgical Adjuvant Breast and Bowel Project examined survival curves for patients in NSABP colon cancer clinical trials to determine how conditional survival improved as patients survived in the years past initial diagnosis. They analyzed survival information for nearly 5,600 patients who had received treatment with 5FU in one of several clinical trials. Patients in these trials all were initially diagnosed with either stage II or III colon cancer.
They found that as the number of years since diagnosis increased without cancer recurring statistical chance of survival increased. At diagnosis the patients studied had a 76% chance survival risk; after 5 years that percentage had increased to 85%. For Stage III patients a 68% risk increased to 88% after 5 years.
Prognostic factors, such as number of positive lymph nodes or stage, that reduced survival risk at diagnosis had almost no significance at 5 years. Patients who were older or had poor performance status unfortunately did not experience a reduction in risk as they continued to live past diagnosis.
In the NSABP study, stage II patients had an 87% chance of overall survival at diagnosis. This remained at 87% after 1 year and increased to 90% at 2 years, 92% at 3 years, 91% at 4 years and, 92% at 5 years. Stage III patients had a 68% survival risk at diagnosis which increased to 72% at 1 year, 81% at 2 years, 87% at 3, 89% at 4, and 88% at 5 years.
In considering this data, is is important to remember that an older treatment was used that did not contain the standard oxaliplatin, that all patients received some form of 5FU, and that the patients were enrolled in clinical trials. So the statistics may not translate to the general population today, although the principles behind conditional survival probably do — the longer a patient lives past diagnosis, the better the chance for disease-free survival.
Samuel Wang, M.D. Ph.D. presented the data.
An additional article about the study appears in Science Daily, June 7, 2006.
ASCO 2006 Abstract 6005 — Conditional survival for patients with colon cancer: An analysis of National Surgical Adjuvant Breast and Bowel Project (NSABP) trials C-03 through C-06.
Posted by Kate Murphy on June 11th, 2006
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