Randomized, open-label, phase III study comparing patupilone (EPO906) with pegylated liposomal doxorubicin in platinum-refractory or -resistant patients with recurrent epithelial ovarian, primary fallopian tube, or primary peritoneal cancer - PubMed (original) (raw)
Clinical Trial
. 2012 Nov 1;30(31):3841-7.
doi: 10.1200/JCO.2011.38.8082. Epub 2012 Sep 17.
Elzbieta Kutarska, Meletios Dimopoulos, Duk-Soo Bae, Izabella Rzepka-Gorska, Mariusz Bidzinski, Giovanni Scambia, Svend Aage Engelholm, Florence Joly, Dirk Weber, Mona El-Hashimy, Jingjin Li, Farida Souami, Patricia Wing, Silke Engelholm, Aristotelis Bamias, Peter Schwartz
Affiliations
- PMID: 22987083
- DOI: 10.1200/JCO.2011.38.8082
Clinical Trial
Randomized, open-label, phase III study comparing patupilone (EPO906) with pegylated liposomal doxorubicin in platinum-refractory or -resistant patients with recurrent epithelial ovarian, primary fallopian tube, or primary peritoneal cancer
Nicoletta Colombo et al. J Clin Oncol. 2012.
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.
Comment in
- Drug development for chronic cancers: time to think differently?
Spriggs DR. Spriggs DR. J Clin Oncol. 2012 Nov 1;30(31):3779-80. doi: 10.1200/JCO.2012.42.3269. Epub 2012 Sep 17. J Clin Oncol. 2012. PMID: 22987092 No abstract available. - Clinical trials of palliative chemotherapy in platinum-resistant or -refractory ovarian cancer: time to think differently?
Friedlander ML, Stockler MR, Butow P, King MT, McAlpine J, Tinker A, Ledermann JA. Friedlander ML, et al. J Clin Oncol. 2013 Jun 20;31(18):2362. doi: 10.1200/JCO.2012.47.7927. Epub 2013 May 13. J Clin Oncol. 2013. PMID: 23669225 No abstract available. - Reply to M.L. Friedlander et al.
Colombo N. Colombo N. J Clin Oncol. 2013 Jun 20;31(18):2363. doi: 10.1200/JCO.2012.48.3750. J Clin Oncol. 2013. PMID: 23930277 No abstract available.
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