PRINCETON, NJ—Bristol-Myers Squibb Company announced in a press release that the FDA has approved a novel, shorter administration regimen for Taxol (paclitaxel) injection for the treatment of advanced ovarian cancer. The new 3-hour regimen offers patients the advantage of administration in an outpatient setting.
In the pivotal trial for the new dosing regimen, conducted by a Canadian-European consortium of cooperative groups, 680 women with stage IIb to IV ovarian cancer were randomized to receive Taxol at a dose of 175 mg/m² in combination with cisplatin(Drug information on cisplatin) (Platinol) (75 mg/m²) as a 3-hour regimen every 3 weeks or the standard therapy (cyclophosphamide 750 mg/m² followed by cisplatin 75 mg/m²).
Women in the Taxol arm experienced significantly improved overall survival, compared with women in the cyclophosphamide(Drug information on cyclophosphamide) arm (35.6 months vs 25.9 months). Progression-free survival was significantly longer for the Taxol patients (15.3 months vs 11.5 months). Further, a large number of patients in the cyclophosphamide arm with progressive disease were subsequently treated with a Taxol-based therapy.
This study also confirmed the safety of the 3-hour Taxol regimen and showed that the combination resulted in a lower incidence of severe neutropenia (33% vs 43% for cyclophosphamide/cisplatin). However, the incidence of myalgia/arthralgia and severe neurotoxicity was greater in the Taxol/cisplatin arm.
Taxol is also approved for use in advanced ovarian cancer at 135 mg/m² over a 24-hour infusion period given in combination with cisplatin (75 mg/m²) every 3 weeks.
