Key points are not available for this paper at this time.
5002 Background: P-C is a global standard for treatment of EOC and PPC (GCIG Consensus Conference 2005). Although effective, most patients recur with resistant disease. Agents were selected for new combinations based on clinical activity, interaction with cisplatin in tumor models, and feasibility. Methods: Eligible pts had appropriate initial surgery without other therapy, GOG/WHO PS 0–2, and adequate vital organ function. Pts were stratified by group, diagnosis (EOC vs PPC), stage (III vs IV), macroscopic residual tumor (yes vs no), and intent for interval cytoreduction (yes vs no). An event-triggered interim analysis (IA) of progression-free survival (PFS) was to identify arms for full accrual. The primary endpoint was overall survival (OS), determined by an event-triggered pair-wise comparison to the standard regimen (intent-to-treat), with a 90% chance of detecting a true hazard ratio (HR) of 1.33, limiting type I error to 1.25% (two-tailed) for each comparison. Sample size to be adjusted based on accrual rate and IA. Results: Accrual exceeded 1200/yr. IA for PFS (May 2004) with 1,345 events. Median PFS ranged from 15.4–17.5 m. PFS HRs ranged from 0.94–1.07 with the standard error of each log HR approximately 0.086. Extension was not recommended, and accrual closed at 4312 pts (177 ineligible). Median age 58 yrs; 13% PPC, 14% stage IV, 22% microscopic. 81% completed therapy, 4% progressed, 9% discontinued for toxicity. At least 42 deaths possibly treatment-related (<1%). Expected hematologic toxicity related to regimen intensity. Conclusions: For the regimens evaluated, there is no evidence that adding a third active cytotoxic agent prolongs PFS in EOC. Analysis of OS and impact of stratification factors are in progress. Table: see text Table: see text
Michael A. Bookman (2006) studied this question.