Gemcitabine/carboplatin (GC) vs. carboplatin (C) in @entity902 sensitive recurrent XXXX ( @entity43 ). Results of a Gynecologic Cancer Intergroup randomized phase III trial of the AGO OVAR, the NCIC CTG and the EORTC GCG.

@entity1 @entity43 @entity137 @entity2841 @entity417 @entity882 @entity1261 @entity12840 @entity16 @entity1398 @entity17079 @entity902
UNASSIGNED: 5005 Background: Most @entity1 (pts) with @entity43 relapse. ICON 4 - AGO OVAR 2.2 results suggest combination C-based therapy may be superior to single agent C. GC is a feasible less neurotoxic regimen and thus of interest to evaluate in this setting. METHODS: In this phase III trial pts with @entity902 sensitive recurrent @entity43 (>=  6 months after the end of primary therapy) were randomized to receive C (AUC 4 d1) plus G (1000 mg/m(2) @entity17079 ) or C (AUC 5 d1) every 3 weeks. The primary objective compared progression free survival (PFS) in both arms. Secondary objectives were response rate (RR) and duration, overall survival (OS), @entity137 and quality of life (QoL). RESULTS: From 09/99 and 04/02, 356 pts (178 GC, 178 C) were randomized. Both study arms were well balanced for baseline disease characteristics. Median number of cycles was 6 for GC (0-10) and C (0-9). The weekly dose intensity was 98.2% for C (C arm) and 96.2% for C and 75.6% (92.8% for @entity12840 and 63.4% for d8) for G (GC arm). Grade 3/4 hematologic @entity137 were significant higher in the GC arm ( @entity417 27.4% of pts. vs. 8.0%, @entity1398 70.3% vs. 12.0%, @entity882 34.9% vs. 11.4%). @entity1261 or @entity2841 was more often used in GC (23.6% of pts. vs. 10.1%) as well as red cell transfusions (37.1% vs. 14.6%). Clinical sequelae were similar between arms: @entity1398 (1.1% GC vs. 0% C) and infections (0.6% for both arms). Grade 3/4 non-hematologic @entity137 were infrequent in both arms (< 5%), especially for @entity16 (1.1% GC vs. 1.7% C). Overall RR for GC was 47.2% (95% CI: 39.9-54.5%) and 30.9% (95% CI: 24.1-37.7) for C (p= 0.0016). GC pts reported significantly faster palliation of abdominal symptoms as well as significantly improved global QoL. With a median follow up of 13 months, median PFS was 8.6 mo (95%CI: 8.0-9.7) for GC and 5.8 mo (95% CI: 5.2-7.1) for C (HR 0.72 [95% CI: 0.57-0.90], p= 0.0038, e= 311). OS data are immature and this study was not powered to detect differences in OS. CONCLUSION: The combination of G plus C improves PFS and QoL in @entity902 sensitive recurrent @entity43 @entity1 with acceptable @entity137 . [Table: see text].
