Paclitaxel plus carboplatin in the treatment of ovarian cancer.

Two large, prospective randomized trials by the Gynecologic Oncology Group and the European Organization for Research and Treatment of Cancer have demonstrated the superiority of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ)/cisplatin compared with cisplatin/cyclophosphamide in previously untreated patients with advanced ovarian cancer. Patients receiving the paclitaxel combination had a higher overall response rate, a longer time to disease progression, and prolonged median survival. In an effort to reduce toxicity, investigators developed combinations of carboplatin/paclitaxel that were found by phase I/II trials to have activity comparable to cisplatin/paclitaxel but with less toxicity. Prospective randomized trials of paclitaxel/cisplatin versus paclitaxel/carboplatin were completed by the Gynecologic Oncology Group and by European investigators and preliminary results identify no differences in efficacy. Clinical trials of new combinations of paclitaxel/carboplatin with oral etoposide, gemcitabine, or epirubicin have recently begun. Additional studies of high-dose chemotherapy regimens of paclitaxel/carboplatin in untreated patients with optimal stage III ovarian cancer also are in progress. The Gynecologic Oncology Group has completed a randomized comparison of three versus six cycles of paclitaxel/carboplatin in early stage disease. This study will be followed by a trial in which all patients with poor-prognosis, early stage ovarian cancer receive three cycles of paclitaxel/carboplatin followed by randomization to no further treatment or to weekly paclitaxel. The combination of paclitaxel/carboplatin is currently the preferred regimen for the treatment of ovarian cancer.

RCT Entities:   Population Interventions Outcomes