PHILADELPHIA--Women with advanced ovarian cancer had 50% longer survival when they received a first-line regimen combining paclitaxel(Drug information on paclitaxel) (Taxol) and cisplatin(Drug information on cisplatin) (Platinol), says William P. McGuire, MD, and his colleagues in the Gynecology Oncology Group (GOG).
Median overall survival was 38 months for the paclitaxel combination vs 24 months for standard cisplatin/cyclophosphamide, he said.
"The results of this trial are extremely significant," said Dr. McGuire, professor of medicine, Emory University, and lead investigator for the study. "It is my strong feeling that all women with this type of ovarian cancer should be primarily treated with paclitaxel and cisplatin. This therapy should become the new standard for advanced ovarian cancer."
The GOG trial involved 386 eligible women with incompletely resected stage III ovarian cancer or any stage IV ovarian cancer who had received no previous chemotherapy or radiation for their ovarian cancer.
The patients were randomized to a regimen of 75 mg/m² of cisplatin plus either 750 mg/m² of cyclophosphamide(Drug information on cyclophosphamide) or 135 mg/m² of paclitaxel, as a 24-hour continuous infusion. Both regimens were given every 3 weeks for a total of six courses. Women receiving paclitaxel were premedicated with dexamethasone(Drug information on dexamethasone), diphenhydramine(Drug information on diphenhydramine), and a histamine H2 antagonist.
In addition to increased overall survival, patients receiving paclitaxel had longer periods of progression-free survival--18 months vs 13 months for standard therapy, Dr. McGuire said in the published report (N Engl J Med 334:1-6, 1996).
Moreover, response rates were higher with paclitaxel. Of 216 women with measurable tumors, 73% receiving paclitaxel/cisplatin responded vs 60% in the standard therapy arm. The complete clinical response rate with paclitaxel/cisplatin was 51% vs 31% for the standard combination treatment.