Offers Slight Improvement in Survival
March 30, 2006 04:43:31 PM PST
People with stomach cancer now have a new treatment option. Drug maker sanofi-aventis says the US Food and Drug Administration has approved its drug docetaxel (sold as Taxotere) for people with advanced disease. The drug may now be given along with other chemotherapy drugs (cisplatin and 5-fluorouracil) to people who have not had prior chemotherapy.
The approval was based on a clinical trial involving 445 patients divided into 2 groups. In the study, those who got the docetaxel-containing chemotherapy regimen lived slightly longer than people treated only with cisplatin and 5-fluorouracil (9.2 months compared with 8.6 months). Adding docetaxel also delayed tumor growth by about 2 months.
Most patients in the study experienced at least 1 severe side effect, although they were more common in those who got the docetaxel-containing regimen.
The most common of the serious side effects were low white blood cell count (neutropenia), anemia, diarrhea, and nausea.
The drug is given into a vein. It is already approved to treat breast cancer, non-small cell lung cancer, and prostate cancer.
Stomach cancer is expected to strike 22,280 Americans in the US in 2006, and to kill about 11,430. Most cases are not diagnosed until they are advanced and begin to cause symptoms.
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