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Paclitaxel as salvage therapy in advanced pretreated ovarian cancer: a phase II study.

The response rate to salvage chemotherapy in advanced ovarian cancer has been disappointing in patients who do not respond or who relapse after platinum-containing regimens. In these cases, the identification of new drugs is a substantial challenge. The efficacy of one of these, paclitaxel, has already been assessed in many phase II trials. From July 1993 to October 1995, 33 patients with advanced ovarian cancer, recurrent or refractory after platinum-based regimens, entered our study. Paclitaxel was given by 3-hour intravenous infusion every 3 weeks. All the patients were evaluable for toxicity and 27 for response. Nine patients (33.3%) responded: 6 complete (22.2%) and 3 partial responses (11.1%). Six responses (35.3%) were observed in the 17 platinum-resistant patients and 3 (30%) in the 10 platinum-responders. World Health Organization (WHO) grade 3-4 neutropenia was common (13/33 patients, 39.4%) and peripheral neurotoxicity was observed in 29 patients (87.8%), but was WHO grade 3 in four cases (12.1%). Alopecia was ubiquitous, whereas other toxic effects were not significant. The overall response rate to paclitaxel in this study is similar to that reported in others and the high complete response (CR) rate should be emphasized. These data confirm the significant activity and safety of this drug in patients with advanced ovarian cancer, even in platinum-resistant cases.