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Patupilone failed to improve survival in ovarian, fallopian tube cancers
Patupilone did not significantly improve survival compared with pegylated liposomal doxorubicin among a cohort of women with ovarian, fallopian tube or primary peritoneal cancers, according to study results.
The patient population for this study included those with platinum-refractory or -resistant epithelial ovarian, primary fallopian tube, or primary peritoneal cancer who had undergone three or fewer prior regimens. Patients also were eligible if they had received first-line taxane/platinum-based combination chemotherapy.
The researchers randomly assigned patients to receive patupilone (Novartis) 10 mg/m2 IV every 3 weeks (n=412) or pegylated liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks (n=417).
The investigators observed no statistically significant difference in OS between the two arms (HR=0.93; 95% CI, 0.79-1.09). Median OS among patients assigned to patupilone was 13.2 months, compared with 12.7 months for patients assigned to pegylated liposomal doxorubicin.
The researchers reported a median PFS of 3.7 months in both groups.
Patupilone was associated with a higher overall response rate, 15.5% vs. 7.9% (OR=2.11; 95% CI, 1.36-3.29). All responses were partial responses.
Disease control rates were similar (59.5% for patupilone vs. 56.3% for pegylated liposomal doxorubicin).
The most commonly reported adverse events among patients in the patupilone group were diarrhea (85.3%) and peripheral neuropathy (39.3%).
Among patients assigned to pegylated liposomal doxorubicin, mucositis/stomatitis occurred in 43% of patients, and hand-foot syndrome occurred in 41.8%.
Disclosure: Several of the researchers report financial relationships with Novartis.