A high risk of life-threatening complications was found to be associated with a chemotherapy regimen that utilized doxorubicin (Adriamycin) and docetaxel (Taxotere) together. The two drugs are frequently used alone to treat breast cancer. Scientists have been exploring the effects of combining them, reportedly so far with mixed results.
According to the study in today’s issue of the Journal of the American Medical Association, French researchers set out to compare five-year, disease-free survival rates in 627 women treated with either doxorubicin plus Taxotere or the more conventional combination of doxorubicin plus cyclophosphamide. But they stopped the study after a little over three years, in 2003.
The patients who died had developed low white blood cell counts, fever and severe intestinal problems. A third woman became severely ill with similar symptoms. The high rate of complications indicated the two-drug combination was too toxic, according to the researchers, led by Dr. Etienne Brain of the Rene Huguenin Cancer Center in Saint-Cloud, France.
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1. This is a typical breast cancer chemotherapy study of the type which has never yielded any kind of meaningful advance. It's being done simply because docetaxel is an on-patent drug which has a Big Pharma sponsor willing to spread around a lot of money to identify and expand indications.
We have produced an entire generation of investigators in clinical oncology who believe that the only valid form of clinical research is to perform well-designed, prospective, randomized trials in which patients are randomized to receive one empiric drug combination versus another empiric drug combination.
We are getting a rapidly-expanding list of treatments which are partially effective in a minority of patients, ineffective in a majority of patients, remarkably effective in a few, isolated patients, while being enormously expensive. The fastest way to improve things is to match treatment to the patient.
All the rigorous clinical trials that have been identified are the best treatments for the average patient. But cancer is not an average disease. Cancer is far more heterogeneous in response to various individual drugs than are bacterial infections.
Many forms of cancer represent heterogenous diseases, where the tumors of different patients have different responses to chemotherapy. It requires individualized treatment based on testing the individual properties of each patient's cancer.
Posted at 4:19PM on Jun 16th 2005 by Gregory D. Pawelski