PRINCETON, NJBristol-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 (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 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.