EXTENDED PHASE-II STUDY OF PACLITAXEL AS A 3-H INFUSION IN PATIENTS WITH OVARIAN-CANCER PREVIOUSLY TREATED WITH PLATINUM

An extended phase II study was performed to evaluate single-agent pacl itaxel as salvage chemotherapy for ovarian cancer. The aim of this stu dy was to evaluate the 3-h infusion schedule of paclitaxel in terms of toxicity and antitumour efficacy. Furthermore, we analysed the impact on response and survival of the extent of prior chemotherapy and stat us of resistance against platinum. This study was an open, non-randomi sed, multicentre trial. The dose of paclitaxel used was 175 mg/m(2) in patients who had received one or two prior therapies, and 135 mg/m(2) in patients who had received three prior therapies. Paclitaxel was gi ven as a 3-h infusion. Courses were repeated every 3 weeks. 114 patien ts with platinum-pretreated epithelial ovarian cancer were recruited o f whom 112 were found eligible and evaluable for toxicity. 104 patient s with bidimensionally measurable disease who received more than one c ourse of chemotherapy were evaluable for response, progression-free (P FS) and survival. Toxicity was generally manageable. Main toxicities w ere non-cumulative neutropenia with 22.3% of courses with WHO grade 3/ 4 and peripheral neuropathy which occurred in more than half of the co urses and was of WHO grade 2 and 3 in 20.1 and 1.3% of the courses, re spectively. Neuropathy was associated with the higher dose per course and with cumulative paclitaxel dose. Objective responses were reported in 20% (21/104) of the patients (95% CI 13-29%) with a median respons e duration of 36.7 weeks. Survival and PFS for the whole group were 45 .9 and 15.1 weeks, respectively. Performance status, number of tumour lesions and extent of prior chemotherapy were found to be prognostic f actors for survival. Extent of prior chemotherapy was the only prognos tic factor for PFS. Platinum resistance did not predict response to tr eatment. Paclitaxel 175 mg/m(2) given as a 3-h infusion is an appropri ate treatment for patients with platinum-resistant ovarian cancer who have not previously received more than two chemotherapy regimens. Pacl itaxel did not show results superior to historical data for platinum r etreatment in patients with platinum-sensitive, recurrent ovarian canc er. (C) 1997 Elsevier Science Ltd.