Bristol-Myers Squibb's Taxol (paclitaxel) can increase survival by more than 50% in women treated for advanced ovarian cancer, according to data published in the New England Journal of Medicine (January 4). The Phase III trial, conducted by the US National Cancer Institute, is the first in 15 years, since cisplatin was developed and incorporated into the initial therapy of ovarian cancer, that has shown a notable improvement in survival in these patients.
Women who received a first-line drug regimen combining paclitaxel and cisplatin lengthened their average survival time by more than 13 months, compared to women who received the current standard chemotherapy regimen of cisplatin and cyclophosphamide (38 versus 24; p<0.001). The NCI trial randomly assigned 386 patients with advanced ovarian cancer to a regimen of either 750mg/mg2 cyclophosphamide and 75mg/m2 cisplatin, or 135mg/m2 paclitaxel and 75mg/m2 of cisplatin. Increased survival rates were accompanied by longer periods of progression-free survival - 17.9 months with paclitaxel/cisplatin therapy compared to 12.9 months (p<0.001). Moreover, of 218 women with measurable tumors, 73% receiving the paclitaxel regimen had tumors that shrank versus 60% in the standard therapy arm (p=0.01).
Side effects of the new therapy were all manageable and included alopecia, neutropenia with and without fever, and allergic reactions. However, while side effects in the experimental arm were more common, they lasted longer in the standard therapy group where persistent neutropenia more often caused delays in scheduled treatments. In addition, more patients in the paclitaxel/cisplatin group finished all six courses of therapy (87% versus 78%).
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