Randomized Phase III Trial of Gemcitabine Compared With Pegylated Liposomal Doxorubicin in Patients With Platinum-Resistant Ovarian Cancer

• DOI: 10.1200/jco.2006.09.6735
• Publication Date: 2007-06-29T22:59:19Z
• Authors: David G. Mutch; Mauro Orlando; Tiana Goss; Michael G. Teneri...; Alan N. Gordon; Scott D. McMeekin; Yanping Wang; Dennis R. Scribner; Martin Marciniack; R. Wendel Naumann; Angeles Alvarez S...
• Keywords: Mucositis; Clinical endpoint; Regimen

Ovarian cancer (OC) patients experiencing progressive disease (PD) within 6 months of platinum-based therapy in the primary setting are considered platinum resistant (Pt-R). Currently, pegylated liposomal doxorubicin (PLD) is a standard care for treatment recurrent Pt-R disease. On basis promising phase II results, gemcitabine was compared with PLD efficacy and safety taxane-pretreated OC patients.Patients (n = 195) were randomly assigned to either 1,000 mg/m2 (days 1 8; every 21 days) or 50 (day 1; 28 until PD undue toxicity. Optional cross-over allowed at withdrawal because Primary end point progression-free survival (PFS). Additional points included tumor response, time failure, survival, quality life.In groups, median PFS 3.6 v 3.1 months; overall 12.7 13.5 response rate (ORR) 6.1% 8.3%; subset measurable disease, ORR 9.2% 11.7%, respectively. None showed statistically significant difference between groups. The group experienced significantly more hand-foot syndrome mucositis; constipation, nausea/vomiting, fatigue, neutropenia but not febrile neutropenia.Although this designed as an equivalency study, seem have comparable therapeutic index population patients. Single-agent may be acceptable alternative OC.