Cancer Decisions - Free Newsletter

HERE AT THE MOSS REPORTS

The one thing we all seem to have too little of these days is time. This is as true for the medical profession as it is for everyone else. While your doctor would almost certainly like to spend more time with you, to explain things in more depth and answer your questions more fully, the constraints imposed by the today's managed care system conspire to make the allocated time per visit ever shorter.

Robbed of the opportunity to discuss their medical needs thoroughly with their physicians, people often turn to the Internet for answers. Certainly, the Internet has unlocked the medical libraries and made vast quantities of formerly unavailable medical literature accessible to everyone. But it has also made available an abundance of unreliable information, often couched in pseudo-scientific language, whose concealed purpose is to sell the unwary a product or service that is essentially worthless. Without the necessary background in the life sciences, it can be extremely hard to discern the fallacies in the sales talk or make sense of journal articles and technical literature.

For thirty years I have been studying cancer and its treatment, monitoring emerging research and writing about new approaches to cancer in the fields of both conventional and alternative medicine. The Moss Reports are the distillation of my long involvement with the field of cancer. Each diagnosis-specific report presents the available treatment options for that particular kind of cancer, discussing the rationale behind the treatment and objectively analyzing the expected success rate, drawbacks and alternatives.

Medical decisions, particularly when the diagnosis is cancer, must be made quickly, and in the current climate of rushed doctor visits it is not always easy to obtain the focused, relevant information you need in order to make good choices.

If you would like to order a Moss Report for yourself or someone you love, you can do so from our website, www.cancerdecisions.com, or by calling 1-800-980-1234 (814-238-3367 from outside the US).

Also available at our Web site are our special reports on important topics in the field of cancer prevention and treatment. These reports are priced at $9.95 each. Currently available are the following:

I am also available for phone consultations with those clients who have purchased a Moss Report. Many patients have told us that such consultations can be enormously helpful in drawing up an effective treatment strategy. To schedule a phone consultation, please call 1-800-980-1234 (814-238-3367 from outside the US) or send an email to Jacquie@cancerdecisions.com.

We look forward to helping you.

TARCEVA IS BECOMING A STANDARD THERAPY FOR LUNG CANCER – BUT DOES IT WORK?

Prominent oncologists are now urging that the 'targeted' drugs Avastin (bevacizumab) and Tarceva (erlotinib) be routinely added to standard chemotherapeutic regimens for non-small cell lung cancer (NSCLC). According to David Ettinger, MD, professor of oncology and medicine at Johns Hopkins University School of Medicine, Baltimore, Md., the addition of these drugs represents "the most important change" in the treatment of this disease (Susman 2006).

Although neither drug offers patients a cure, Dr. Ettinger told United Press International, both agents allegedly prolong survival. "A few years ago, the idea that we could have a two-year survival for patients with stage 4 non-small cell lung cancer was not in the picture," Ettinger declared at the 11th annual conference of the National Comprehensive Cancer Network (NCCN) in Hollywood, Fla. "But now we are seeing that 22 percent of these patients are surviving two years and longer." (The NCCN is a consortium of 19 major cancer hospitals, including both Johns Hopkins and Memorial Sloan-Kettering. It has been writing algorithms for the treatment of various forms of cancer since 1996. The guidelines are used as a standard of care in government demonstration projects and have gained national and international acceptance.)

The UPI article gave full exposure to Dr. Ettinger's views but failed to mention the fact that he himself has performed contract work for OSI, the developer of Tarceva, and has been a consultant to Genentech, the American manufacturer of both Tarceva and Avastin.

In the same article, Mark Kris, MD, chief of the thoracic oncology service at Memorial Sloan-Kettering Cancer Center in New York, echoed Dr. Ettinger's sentiments. He claimed that the use of the targeted therapies extends overall survival in NSCLC by about four months compared to treatments that do not include these agents. He waxed enthusiastic about the future of such therapies.

"I can see the time that we will be able to treat advanced lung cancer much the way we treat people with diabetes – as a chronic disease," he said. The UPI article failed to point out that, like Dr. Ettinger, Dr. Kris has also received research funding as well as consulting fees from Genentech and other companies in the targeted therapy field.

I have previously written critically about Avastin, but what about Tarceva? How effective is it?

Many of the positive assessments of Tarceva are based on a study carried out by the National Cancer Institute of Canada Clinical Trials Group. This study followed 731 patients who had already failed first-line or second-line chemotherapy, usually including one of the platinum-based drug regimens (including cisplatin, carboplatin, etc.). These patients were then given either 150 milligrams per day of Tarceva or an inert placebo (look-alike) pill. The overall response rate was less than 8.9 percent in the Tarceva group and the median duration of this response was 7.9 months. For the NSCLC patients as a whole, the overall survival rate was 6.7 months for those receiving Tarceva vs. 4.7 months for those who got placebo, i.e., an absolute gain of two months. Five percent of the patients discontinued Tarceva because of excess toxicity (Shepherd 2005). The study reported that 31.2 percent of patients receiving Tarceva were alive at one year vs. 21.5 percent in the placebo arm of the trial. This is the source of the claim that Tarceva extends survival by "several months."

At the Tarceva.com Web site, the manufacturer, Genentech, Inc, indulges in a now very familiar piece of statistical sleight of hand, presenting the survival gain for Tarceva in relative (as opposed to absolute) terms. Thus a two-month absolute survival gain is expressed as a "42.5 percent improvement" in survival! That sounds a lot more impressive than a mere eight weeks survival benefit. By expressing the advantage as a relative survival percentage increase, the manufacturer is able to project a misleadingly rosy impression of what the drug actually does.

Often overlooked is the fact that, a few months later, a larger trial, named the TRIBUTE study, based at M.D. Anderson Cancer Center, Houston, came up with essentially negative conclusions on the value of Tarceva. In the TRIBUTE trial, Tarceva was combined with chemotherapy to determine if it could improve the outcome for patients with advanced (stage IIIB or IV) NSCLC. Experimental subjects with good performance status who had not been previously treated received six cycles of the standard drugs carboplatin and paclitaxel along with 150 milligrams per day of Tarceva. This was followed by single-agent maintenance therapy of Tarceva. A comparison group received the identical chemotherapy with only a placebo (look-alike) pill instead of Tarceva.

The median overall survival time for patients treated with Tarceva was 10.6 months vs. 10.5 months for those getting placebo. In other words, Tarceva had NO impact on survival in this patient population. Nor was there any difference in the overall response rate, nor in the median time to progression. Patients taking Tarceva experienced an increased incidence of the extensive rash and diarrhea that is characteristic of the drug.

In a subgroup analysis, those relatively few patients who reported never having smoked experienced some improvement in overall survival after taking Tarceva (22.5 v 10.1 months for placebo). No other pre-specified factors were associated with an increase in overall survival with Tarceva. Thus, among lifelong non-smokers Tarceva might add about one year of extra survival.

The authors concluded that Tarceva plus standard chemotherapy "did not confer a survival advantage over carboplatin and paclitaxel alone in patients with previously untreated advanced NSCLC." However, "never smokers" treated with Tarceva and chemotherapy "seemed to experience an improvement in survival" and will hopefully be the subject of further investigation in future randomized trials. There are certain mutations of epidermal growth factor receptor (EGFR) that are common in nonsmokers with lung cancer compared to smokers who develop what is ostensibly the same diagnosis. Thus nearly 50 percent of non-smokers in one Sloan-Kettering study had these EGFR mutations, while just five percent of the smokers in the study did (Pao 2004).

To be concluded, with references, next week

--Ralph W. Moss, Ph.D.

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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.