(ChemotherapyAdvisor) – Patupilone did not significantly improve overall survival (OS) compared with pegylated liposomal doxorubicin (PLD) in patients with platinum-refractory or -resistant ovarian cancer, results of an open-label phase 3 study reported in the Journal of Clinical Oncology online September 17.
“Progression of ovarian cancer within 6 months after a platinum containing regimen portends a poor prognosis,” stated Nicoletta Colombo, MD, of the University of Milan-Bicocca, Milan, Italy, and colleagues. “The limited efficacy of subsequent chemotherapy regimens and poor survival outcomes highlight the need for additional treatment options.”
Noting the study was the “largest clinical trial in this patient population to our knowledge,” the investigators randomly assigned 829 women with platinum-refractory or -resistant epithelial ovarian, primary fallopian tube, or primary peritoneal cancer who had received ≤3 prior regimens including first-line taxane/platinum-based combination chemotherapy to patupilone 10mg/m2 every 3 weeks (n=412) or PLD 50mg/m2 every 4 weeks (n=417).
At a median follow-up of 27 months, OS, the primary end point, was 13.2 months in the patupilone arm and 12.7 months in the PLD arm (P=0.195; HR 0.93; 95% CI, 0.79–1.09); 1-year survival rates were 53.8% and 52.0%, respectively. Median progression-free survival was 3.7 months for both arms.
Overall response rate was 15.5% in the patupilone arm and 7.9% in the PLD arm (all partial responses; OR 2.11; 95% CI, 1.36–3.29), and disease control rates were 59.5% and 56.3%, respectively.
Any grade adverse events (AEs) 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, with no new or unexpected serious AEs identified.
“Ovarian cancer is largely becoming a chronic disease, and the availability of multiple active drugs is crucial in prolonging survival,” they wrote. “However, toxicity and quality of life become important in this palliative setting. Therefore, further testing of patupilone to reduce toxicity should not be precluded.”