Author(s): Colombo N, Kutarska E, Dimopoulos M, Bae DS, RzepkaGorska I,
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Abstract PURPOSE: This study compared the efficacy and safety of patupilone with those of pegylated liposomal doxorubicin (PLD) in patients with platinum-refractory or -resistant epithelial ovarian, primary fallopian tube, or primary peritoneal cancer. PATIENTS AND METHODS: Patients with three or fewer prior regimens were eligible if they had received first-line taxane/platinum-based combination chemotherapy and were platinum refractory or resistant. Patients were randomly assigned to receive patupilone (10 mg/m(2) intravenously every 3 weeks) or PLD (50 mg/m(2) intravenously every 4 weeks). RESULTS: A total of 829 patients were randomly assigned (patupilone, n = 412; PLD, n = 417). There was no statistically significant difference in overall survival (OS), the primary end point, between the patupilone and PLD arms (P = .195; hazard ratio, 0.93; 95\% CI, 0.79 to 1.09), with median OS rates of 13.2 and 12.7 months, respectively. Median progression-free survival was 3.7 months for both arms. The overall response rate (all partial responses) was higher in the patupilone arm than in the PLD arm (15.5\% v 7.9\%; odds ratio, 2.11; 95\% CI, 1.36 to 3.29), although disease control rates were similar (59.5\% v 56.3\%, respectively). Frequently observed adverse events (AEs) of any grade included diarrhea (85.3\%) and peripheral neuropathy (39.3\%) in the patupilone arm and mucositis/stomatitis (43\%) and hand-foot syndrome (41.8\%) in the PLD arm. CONCLUSION: Patupilone did not demonstrate significant improvement in OS compared with the active control, PLD. No new or unexpected serious AEs were identified. TRIAL REGISTRATION: ClinicalTrials.gov NCT00262990.
This article was published in J Clin Oncol
and referenced in Journal of Clinical & Experimental Pharmacology