Epirubicin/Paclitaxe/Carboplatin (Tec) Vs Paclitaxe/Carboplatin (Tc) In First-Line Treatment Of Ovarian Cancer (Oc) Figo Stages Iib-Iv. An Ago-Gineco Intergroup Phase Iii Trial.

5007 Background: The addition of further drugs to TC is regarded as an option for improving 1st-line therapy in OC. Anthracyclines have shown activity in OC and are among the drugs suitable for evaluation in triple drug regimens. Methods: We performed a randomized phase III trial in pts. with advanced OC stages FIGO IIB-IV to determine the role of epirubicin (E) when added to TC. Pts were randomized to receive 6 cycles of either T 175 mg/m2 3 h iv + C AUC 5 (according to Calvert formula) + E 60 mg/m2 iv (TEC) or TC at same doses, both regimens given every 3 weeks. Pts. were stratified per center and according to FIGO stage and post-operative residual tumor (RT): stratum I ‘FIGO IIB-IIIC and RT =/<1 cm’; stratum II ‘FIGO IIB-IIIC and RT > 1 cm or FIGO IV’. Primary endpoint was overall survival (OS), secondary endpoints were progression-free survival (PFS), overall response (OR; complete + partial), toxicity, quality of life, and stratified analysis of OS. Results: From 11/97 to 2/00 1,282 pts. were randomized and 647 and 635 were enrolled in the TEC and TC arm, respectively. 743 pts (58%) were classified as stratum 1. More than 86% of pts received 6 or more courses. TEC induced more myelotoxicity, e.g. grade (G) 3/4 neutropenia was observed in 75.6% and 55.5% after TEC and TC (p 10 mm), but for histological subtypes; the latter suggested superior efficacy for TEC in endometrial OC. Conclusions: The addition of E to TC did not result in superior OR, PFS and OS, but induced more toxicity and costs. Therefore, TEC cannot be recommended as first-line therapy of advanced OC in clinical routine. Further research should focus on the role of anthracylines in endometrial OC. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bristol-Myers Squibb Bristol-Myers Squibb Bristol-Myers Squibb; Pharmacia Bristol-Myers Squibb Bristol-Myers Squibb