Cancer Decisions - Free Newsletter

HERE AT THE MOSS REPORTS

We are dedicated to bringing our readers and clients the latest and most interesting developments in the field of cancer research and treatment.

The Moss Reports is a comprehensive series of detailed individual reports on more than 200 different kinds of cancer. Each of these diagnosis-specific reports analyzes the current available treatments, both conventional and alternative, and offers the cancer patient a clear-eyed, truthful assessment of the available options. If you would like to purchase a Moss Report for yourself or someone you love, you can do so securely from our Web site (www.cancerdecisions.com), or by calling 1-800-980-1234 (814-238-3367 from outside the US).

I also offer phone consultations to clients who have bought a Moss Report. A phone consultation can be enormously helpful in drawing up a treatment strategy and getting one’s options clearly prioritized. A recent client offered the following comment:

"I want to express my thanks to Dr. Moss for the telephone consultation. I had done a fair amount of research before our conversation and had received advice about the treatments the oncologists felt I needed. The oncologists did not take into consideration my specific case, so it was so good to discuss my situation with Dr. Moss and receive advice and information I believe is not biased toward any specific treatment. It was so helpful and I have no doubts about the course I have chosen. Thank you so much." - S. F.

To schedule an appointment for a phone consultation, please email: Jacquie@cancerdecisions.com, or call 1-800-980-1234 (814-238-3367 from outside the US).

We look forward to helping you.

CURRENT TOPICS

A question that comes up very frequently in phone consultations with my clients is the issue of whether or not it is safe to take antioxidants while undergoing standard cancer treatments such as chemotherapy or radiation.

While there is mounting evidence to suggest that antioxidants are both safe and effective in counteracting the unpleasant side effects of chemotherapy and radiation, by and large the oncology profession tends to recommend strongly against the use of such supportive measures, citing concerns that antioxidants may interfere with the cancer-killing ability of standard treatments.

I have written an investigative report on this controversial subject, exposing the flaws in the arguments so often leveled against the use of antioxidants during cancer therapy. The report - Do Antioxidants and Chemotherapy Conflict? - is available for download from the Cancer Decisions web site: www.cancerdecisions.com.

This report is one of our Current Topics series - a growing list of in-depth analyses that focus on issues of importance to all who are interested in cancer prevention and treatment. Other Current Topics include:

On Guard - Gardasil (A discussion of the anti-cervical cancer vaccine Gardasil)
Do Antioxidants and Chemotherapy Conflict?
Mammography, Biopsy and the Diagnosis of Breast Cancer
Herceptin or Deceptin? (An evaluation of the use of Herceptin in breast cancer)
Avastin: Your Money Or Your Life. (A clear-eyed look at the targeted drug Avastin)
The Politics of Hope: Andrew von Eschenbach and the Decline of the National Cancer Institute
The Mexican Cancer Clinics in the Era of Evidence-Based Medicine

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DOES TYKERB REALLY WORK? - PART TWO

(Last week we began an article on the new drug Tykerb (lapatinib), which has been approved for the treatment of advanced breast cancer. We conclude the article this week.)

In the clinical trial that led to the approval of Tykerb, patients who took Tykerb plus the oral chemotherapy drug Xeloda had on average two months longer before their disease progressed than those taking Xeloda alone. How important is this?

Of course, two months more with stable disease is still two months worth having. But there is something missing from this picture - information about actual survival. Extending the time to progression is not the same thing as prolonging the length of time a patient is likely to live.

Clinical trials are frequently set up with an independent review board in place that can perform an interim analysis of the data and decide if one of the approaches under examination is doing significantly better than another. If so, the trial may be prematurely terminated and, for ethical reasons, the better treatment may then be offered to all the participants. This is precisely what happened in the Tykerb trial.

By terminating the trial, the oversight committee also served the interests of the drug company, which was able to "quit while it was ahead," i.e., while the trial data still looked highly positive. Naturally, it is important for oversight committees in clinical trials to worry about the ethics of withholding a drug that might prove effective. But what about the ethics of approving and administering a drug to tens of thousands of women before there is data showing that it has a positive effect on their survival?

Most doctors and breast cancer advocates seemed happy enough to have another new drug to treat advanced breast cancer. But the lack of survival information left at least one advocacy group disappointed. Barbara A. Brenner, executive director of Breast Cancer Action, reminded the FDA in a March 5 letter that it is overall survival, rather than a temporary stay of disease progression, that gives a truer picture of a cancer drug’s efficacy.

"The FDA should not approve drugs that have not shown either a survival benefit or improved quality of life for breast cancer patients with metastatic disease," Brenner’s letter read in part. (By way of disclosure, I am on the scientific advisory board of Breast Cancer Action.)

It will be encouraging if further analysis reveals that Tykerb does extend overall survival. However, it seems unlikely that this will be tested or reported any time soon. But without evidence of prolongation of survival in advanced breast cancer, we have to question the real value of this treatment.

As Barbara Brenner says, the real bottom line is increased survival. Will drugs such as Tykerb really help patients spend more quality time with their loved ones? Such questions are rarely asked, much less answered, by FDA panels and officials who are often under considerable pressure to approve a new drug. Despite the existence of rules that require drug companies to carry out extended (phase IV) studies after a drug has been approved, these rules are very seldom enforced. Effectively, this lowers the standard of approval considerably, and in effect turns the population at large into guinea pigs for the long term safety and effectiveness tests that should have been conducted before the drug was ever launched.

--Ralph W. Moss, Ph.D.

References:

Alain Ravaud ASCO study:
http://www.asco.org/portal/site/ASCO/menuitem.34d60f5624ba07fd50
6fe310ee37a01d/?vgnextoid=76f8201eb61a7010VgnVCM100000ed730ad1RC
RD&vmview=abst_detail_view&confID=40&abstractID=33904

Cameron D, Stein S, Zaks T, et al. Lapatinib plus Capecitabine Shows Superior Efficacy Compared to Capecitabine Alone in Patients with ErbB2 Positive Advanced or Metastatic Breast Cancer- Initial Biomarker Data. Proceedings from the 29th Annual San Antonio Breast Cancer Symposium (SABCS). San Antonio, Texas. Oral presentation December 15, 2006. Abstract 2.

CBS News report on Tykerb clinical trial re-analysis by GlaxoSmithKline:
http://www.cbsnews.com/stories/2007/03/13/health/main2564600.shtml

Geyer CE, Forster J, Lindquist D, et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med. 2006;355:2733-2743. Erratum in: N Engl J Med. 2007 Apr 5;356(14):1487.

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IMPORTANT DISCLAIMER

The news and other items in this newsletter are intended for informational purposes only. Nothing in this newsletter is intended to be a substitute for professional medical advice.