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A prospective phase II study was conducted to evaluate the efficacy and toxicity of oxaliplatin plus 5- fluoruracil (5- FU)- and high- dose leucovorin (LV) (FOLFOX- 4) in patients with platinum- resistant, taxane- pretreated recurrent ovarian cancer. Thirty- eight patients, with a median age of 58 years (range 33- 77), were treated with oxaliplatin 85 mg m- 2 as a 2- h infusion on day 1, LV 200 mg m- 2 day- 1 as a 2- h infusion followed by bolus 5- FU 400 mg m- 2 day- 1 and a 22- h infusion of 5- FU 600 mg m- 2 day- 1 for 2 consecutive days. Treatment was repeated every 3 weeks. Patients were evaluated for response every two cycles. The vast majority of patients had performance status 0 or 1 and 76.3% had ≥ 2 metastatic sites. A median number of four cycles per patient (range, 1- 8) were administered. Based on an intention- to- treat analysis, 3 patients (7.9% ) achieved a complete response (CR) and 8 (21.1% ) achieved a partial response (PR), for an overall response rate of 29% . Another 29% of patients had stable disease (SD). The median relapsefree survivalwas 5.2 months (range 2.5- 17), the median time to tumor progression was 4.8 months (range 0.6- 19), and the median overall survival was 10.1 months (range 0.2- 36). Toxicity was mild to moderate. Grade 3/4 neutropenia and thrombocytopenia occurred in 29% and 21.1% of patients, respectively. Febrile neutropenia was encountered in 3 patients (7.9% ), who were successfully treated. Grade 3/4 neurotoxicity developed in 15.8% of patients; neurotoxicity gradually declined after treatment discontinuation. Alopecia, nausea- vomiting, diarrhea, mucositis, and asthenia were not a serious problem. There were no treatment- related deaths. The combination of oxaliplatin and 5- FU/LV (FOLFOX- 4) appears to be an effective regimen with a good toxicity profile for the treatment of platinum- resistant, taxane- pretreated ovarian cancer.
A prospective phase II study was conducted to evaluate the efficacy and toxicity of oxaliplatin plus 5-fluoruracil (5- FU) - and high- dose leucovorin (LV) (FOLFOX-4) in patients with platinum- resistant, taxane- pretreated recurrent ovarian Thirty-eight patients, with a median age of 58 years (range 33-77), were treated with oxaliplatin 85 mg m- 2 as a 2- h infusion on day 1, LV 200 mg m- 2 day- 1 as a 2- h infusion followed by bolus 5- FU 400 mg m- 2 day- 1 and a 22- h infusion of 5- FU 600 mg m- 2 day- 1 for 2 consecutive days. Treatment was repeated every 3 weeks. Patients were evaluated for response every two cycles. The vast majority of patients had performance status 0 or 1 and 76.3% had ≥ 2 metastatic sites. Based on an intention - to treat treat, 3 patients (7.9%) achieved a complete response (CR) and 8 (21.1%) achieved a partial response (PR), for an overall response rate of 29% The median time to tumor progression was 4.8 months (range 0.6-19), and the median overall survival was 10.1 months (range 0.2-36). Toxicity was mild to moderate. Grade 3/4 neutropenia and thrombocytopenia occurred in 29% and 21.1% of patients, respectively. Febrile neutropenia was encountered in 3 patients (7.9%), who were successfully treated. Grade 3/4 neurotoxicity developed in 15.8% of patients; neurotoxicity gradually declined after treatment discontinuation. Alopecia, nausea-vomiting, diarrhea, mucositis, and asthenia were not a serious problem. There were no treatment- related deaths. The combination of oxaliplatin and 5 - FU / LV (FOLFOX-4) appears to be an effective regimen with a good toxicity profile for the treatment of platinum-resistant, taxane-pretreated ovarian cancer.