First line treatment of ovarian/tubal/peritoneal cancer FIGO stage IIb-IV with paclitaxel/carboplatin with or without epirubicin (TEC vs TC). A Gynecologic Cancer Intergroup study of the NSGO, EORTC GCG, and NCIC CTG. Results on progression free survival

Abstract

5003 Background: Adding anthracyclin to conventional platinum based chemotherapy of ovarian cancer has been found to improve survival. The aim of the present study was to evaluate the effect on survival of adding epirubicin to the standard treatment with carboplatin and paclitaxel. Methods: Between March 1999 and August 2001, 887 patients were randomized to receive 6–9 cycles of paclitaxel (175 mg/m2, 3 h iv) followed by carboplatin (AUC 5, Calvert formula) with or without epirubicin (75 mg/m2 iv prior to paclitaxel) on a 3-weekly schedule. The primary endpoint was progression-free survival and 542 progression events were required to detect a hazard ratio of 0.786 or less. Results: Patient characteristics were similar across the treatment arms. Residual disease less than 1 cm at surgery with no measurable disease before chemotherapy was reported in 328 patients (37%), with 159 in the TEC and 169 in the TC arm. A total of 63 patients had to be withdrawn from the study, 20 were ineligible, 32 due to hyperse...