PACLITAXEL (TAXOL) IN HEAVILY PRETREATED OVARIAN-CANCER - ANTITUMOR-ACTIVITY AND COMPLICATIONS

Objective: To analyze the efficacy and toxicity of Taxol in patients w ith ovarian cancer who had failed at least two previous chemotherapy t reatment regimens. Patients and methods: Sixty-eight patients with adv anced pretreated ovarian cancer, with either measurable or evaluable d isease who were shown to have disease progression were entered on a Na tional Cancer Institute sponsored 'compassionate' treatment referral c enter protocol and received intravenous infusion of Taxol over 24 hour s 135 mg/m(2), (after steroid-containing premedication) repeated every 3 weeks and continued while showing no evidence of progression. Resul ts: Of the 68 patients enrolled, 10 patients (15%) had a partial respo nse and one assessable by marker only had improvement of disease. In a ddition, 27 others (40%) were stable on continued Taxol for a median t ime of 6.4 months and CA-125 decreased in 20 patients out of 59 patien ts with elevated baseline CA-125s. Twenty-seven patients progressed wh ile receiving 1-6 cycles of treatment. Three patients were not evaluab le for response. Neutropenia and its complications occurred primarily during the first two cycles of Taxol treatment. Febrile episodes requi ring antibiotic treatment occurred in 44% of patients which is a highe r incidence than in prior series. Conclusions: Taxol as a single agent has modest activity in heavily pretreated ovarian cancer patients but appears to be useful and is subjectively well tolerated by many. The high incidence of infection in comparison with other series of patient s with ovarian cancer treated with chemotherapy suggests this pretreat ed patient population has enhanced susceptibility to develop complicat ions from neutropenia. Safer treatment in this advanced setting should include more aggressive use of cytokines and/or less myelosuppressive regimens (e,g. shorter Taxol infusions).