Study Says High-Cost Cancer Drugs Have Little Benefit, Strain Health System
Main Category: Cancer / OncologyAlso Included In: Public Health
Article Date: 01 Jul 2009 - 3:00 PDT
"Crunching data from published studies, the authors found that treating a lung-cancer patient with Erbitux, a drug that costs $80,000 for an 18-week regimen, prolongs survival by only 1.2 months," the Wall Street Journal reports. The study, which estimates that the life of each American who dies or cancer could be extended by one year at the cost of $440 billion, was published in the Journal of the National Cancer Institute.
The high cost and relatively low benefit points to "one of the thorniest questions facing lawmakers working on the overhaul of the U.S. health-care system": reducing growing health care spending in the last months of patient's lives. "Some countries, like the United Kingdom, agree to pay for expensive drugs only if they meet a certain threshold of efficacy, but no such rationing exists in the U.S.," the Journal reports.
"While some policy experts consider the rationing of health-care resources inevitable in the quest to control medical spending, many Americans have long resisted putting the collective fiscal good over their individual health" (Johnson, 6/29).
This information was reprinted from kaiserhealthnews.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery at kaiserhealthnews.org.
© Henry J. Kaiser Family Foundation. All rights reserved.
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Erbitux For Lung Cancer
posted by Gregory D. Pawelski on 1 Jul 2009 at 8:08 pmThe FDA has been seeking to broaden the range of use for cancer drugs. When they approve a drug for sale, they limit how drug makers sell it. A drug approved to treat only breast cancer cannot be marketed for lung cancer even if some studies suggest that the medicine may save some lung cancer patients.
But the FDA has proposed new guidelines that would change all this. The new rules would allow drug makers to provide physicians with copies of medical journal articles that discuss product uses that have not been vetted or approved by the FDA. Drug companies do not have to promise to adequately test the unapproved use discussed in the article.
Physicians are not overseen by the FDA. Medicine is regulated by state medical boards which let them prescribe drugs as they see fit regardless of FDA judgements. Physicians can prescribe drugs for unapproved uses. If the FDA doesn't end up approving Erbitux for lung cancer, it'll end up being used "off-label" for lung cancer anyway. It may end up finally being approved the way Avastin was finally approved for breast cancer.
Erbitux is a monoclonal antibody just like Avastin, but directed at a different protein. In addition to VEGF, researchers have identified a dozen other activators of angiogenesis, some of which are similar to VEGF. Erbitux binds to EGFR, a protein on the surface of a cell. It targets EGFR protein-tyrosine kinases.
But all the EGFR mutation or amplification studies can tell us is whether or not the cells are potentially susceptible to this mechanism (pathway) of attack. It doesn't tell you if Erbitux is better or worse than another drug which may target this. There are differences.
The drugs have to get inside the cells in order to target anything. In different tumors, either Erbitux or another drug might get in better or worse than the other. And the drugs may also be inactivated at different rates, also contributing to sensitivity versus resistance. Remember, why do some lung cancers stop responding to Tarceva? Why go through so much "trial-and-error?"
EGF-targeted drugs are poorly-predicted by measuring the ostensible target EGFR, but can be well-predicted by measuring the effect of the drug on the "function" of live cells. Without "individualized" testing, it's difficult to determine which drugs are best for patients.
More and more physicians and patients are turning to individualized therapies to treat cancers. Under this approach, scientists study how an individual's cancerous cells respond to several drugs. Doctors have learned that even when the disease is the same type, different patients' tumors respond differently to chemotherapeutic drugs. Without individualized testing, it's difficult to determine which drugs are best for patients.
There are numerous different therapeutic drug regimens out there. Any one or combination of them can help cancer patients. The system is overloaded with drugs and under loaded with wisdom and expertise for using them. What's needed is to make extensive use of bio-marker tests in treatment decisions.
The cell culture methodology maintains cancer cells in their native state, making cell-based assays of chemo compounds more reliable. The test relies on cells, rather than genetic tests, because the complexities and redundancies of human biology are beyond the ken of genomics.
Cancer is a complex disease and needs to be attacked on many fronts. The best thing to do is to combine these different tests in ways which make the most sense. The future of cancer therapy will be personalized treatments for individual patients, and will require a combination of novel diagnostics and therapeutics.
Improving cancer patient diagnosis and treatment through a combination of cellular and gene-based testing will offer predictive insight into the nature of an individual's particular cancer and enable oncologists to prescribe personalized treatment more in keeping with the heterogeneity of the disease. The biologies are very different and the response to given drugs is very different.
Literature Citation: Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18S (June 20 Supplement), 2006: 17117
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