Response: Re: Randomized Intergroup Trial of Cisplatin–Paclitaxel Versus Cisplatin–Cyclophosphamide in Women With Advanced Epithelial Ovarian Cancer: Three-Year Results

Extract

The intergroup study (1) was designed to confirm the impressive results of the combination of paclitaxel and cisplatin in the first-line treatment of advanced ovarian cancer as demonstrated in the Gynecologic Oncology Group (GOG) #111 trial (2). At the time that we initiated the intergroup study, these impressive results showed a statistically significant advantage with regard to response rate and a statistically significant advantage with regard to progression-free survival (PFS) in favor of paclitaxel–cisplatin therapy.

The intergroup study was able to demonstrate that paclitaxel–cisplatin showed a statistically significant advantage with regard to PFS and, importantly, with regard to overall survival (OS). We have clearly explained our choice of PFS as the end point (instead of the response rate); i.e., we had anticipated a wide availability of paclitaxel salvage therapy at the time that the study was conducted. Therefore, we implemented a strict policy of no secondary treatment before documentation of disease progression. In this study, almost half of the patients who had received cyclophosphamide–cisplatin as initial therapy were administered paclitaxel upon first documented progression of disease. Despite this fact (which should have confounded the effect of paclitaxel), the combination of paclitaxel and cisplatin was shown to be statistically significantly superior with regard to OS to the combination of cyclophosphamide and cisplatin (or to the combination of cyclophosphamide and cisplatin followed by paclitaxel): Patients receiving paclitaxel–cisplatin upfront could enjoy a statistically significantly longer time until disease progression and a statistically significantly longer survival (median survival increased by 10 months).