Reports From the Field
FDA approves outpatient ovarian cancer therapy
Bristol-Meyers Squibb in Princeton, NJ, recently announced that the Food and Drug Administration has approved a new, shorter administration regimen for Taxol injection for the treatment of advanced ovarian cancer.
The new three-hour regimen can be administered in the outpatient setting, avoiding the hospitalization required for standard therapy.
In a clinical trial of 680 women with stage IIb through stage IV ovarian cancer, women were randomized to receive either Taxol at 175 mg/m2 followed by cisplastin at 75 mg/m2 in a three-hour infusion every three weeks or cyclophosphamide 750 mg/m2 followed by cisplastin 75 mg/m2 over three hours, every three weeks for a median of six courses.
Women in the Taxol group experienced significantly improved overall survival compared with women in the cyclophosphamide group, 35.6 months vs. 25.9 months. Further, progression-free survival in the Taxol group remained significantly higher for the women who received Taxol at 15.3 months, compared with 11.5 months for the cyclophosphamide group.
Full prescribing information for Taxol is available by calling (800) 426-7644 or visiting Bristol-Meyers Squibb’s Web site at www.bms.com.