Oxaliplatin and paclitaxel combination in patients with platinum-pretreated ovarian carcinoma: an investigator-originated compassionate-use experience.

摘要

PURPOSE: Compassionate-use oxaliplatin paclitaxel was assessed for toxicity and efficacy according to clinical platinum resistance status in cisplatin-carboplatin-pretreated advanced ovarian cancer patients. PATIENTS AND METHODS: Thirty-seven patients, retrospectively grouped into four oxaliplatin-paclitaxel dose levels (mg/m2): (DL1: 100/135; DL2: 130-135/135; DL3: 100/160-175; DL4: 130-135/160-175), received oxaliplatin and paclitaxel every three to four weeks. RESULTS: Thirty-one of thirty-seven treated patients were evaluable for activity, with 1 complete and 14 partial responses, (objective response rate: 48%, 95% CI: 31-66). Of 18 platinum-resistant patients 6 responded, and of 13 platinum-sensitive patients, 9 responded. One patient (3%) had two febrile neutropenia episodes, and eight (22%) and eleven patients (30%) had grades 3 and 4 neutropenia, respectively. Six patients (16%) experienced grade 3 peripheral neuropathy. The median response duration was 10.8 months, with a 23-month (range 8-54) median follow-up. Median progression-free and overall survivals were 9 months (95% CI: 7-12), and 25.2 months (95% CI: 12-39), respectively. CONCLUSIONS: The antitumour activity of oxaliplatin-paclitaxel in platinum-resistant ovarian cancer patients accords with experimental data on the agents' lack of cross-resistance. Time-related progression parameters confirm it as a promising salvage treatment option.