RCT: Patupilone vs. pegylated liposomal doxorubicin in patients with epithelial ovarian, primary fallopian tube, or primary peritoneal cancer - NeLM

RCT: Patupilone vs. pegylated liposomal doxorubicin in patients with epithelial ovarian, primary fallopian tube, or primary peritoneal cancer - NeLM

RCT: Patupilone vs. pegylated liposomal doxorubicin in patients with epithelial ovarian, primary fallopian tube, or primary peritoneal cancer

Reference: J Clin Oncol published early online on 17 September 2012

Source: J Clin Oncol

Date published: 18/09/2012 17:17

Summary

by: Hina Radia

The Journal of Clinical Oncology has featured a phase III study evaluating the safety and efficacy of patupilone vs. pegylated liposomal doxorubicin (PLD) in patients with platinum-refractory or -resistant epithelial ovarian, primary fallopian tube, or primary peritoneal cancer.

The study involved a total of 829 patients who had received three or fewer prior regimens and who had received first-line taxane/platinum-based combination chemotherapy and were platinum refractory or resistant. Patients were randomised to receive either patupilone 10 mg/m2 intravenously every 3 weeks (n=412) or PLD 50 mg/m2 intravenously every 4 weeks (n=417). The primary endpoint was overall survival, and secondary endpoints were progression-free survival (PFS) and overall response rate (ORR). The following results were reported:

• The median overall survival rates were 13.2 months for patupilone and 12.7 months for PLD (Hazard ratio 0.93; 95% CI 0.79 to 1.09; p=0.195)

• The overall response rate (all partial responses) was higher in the patupilone arm than in the PLD arm (15.5% v s. 7.9%; odds ratio, 2.11; 95% CI, 1.36 to 3.29)

• Frequently observed adverse events 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.

The researchers concluded that patupilone did not demonstrate a statistically significant improvement compared to PLD in patients with platinum-refractory or -resistant epithelial ovarian, primary fallopian tube, or primary peritoneal cancer.