Oxaliplatin plus high-dose leucovorin and 5-fluorouracil (FOLFOX 4) in platinum-resistant and taxane-pretreated ovarian cancer: A phase II study

Abstract

ObjectiveA 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. Patients and methodsThirty-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. ResultsThe 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 relapse-free survival was 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. ConclusionThe 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.