Long-term follow-up of a randomized trial comparing conventional paclitaxel and carboplatin with dose-dense weekly paclitaxel and carboplatin in women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer: JGOG 3016 trial.

Abstract

5003 Background: The primary analysis of the JGOG3016 trial (Lancet 2009, 374:1331) showed that dose-dense weekly administration with paclitaxel and carboplatin (dd-TC) demonstrated statistically significant efficiency over tri-weekly administration withTC (c-TC) as first-line chemotherapy in patients with stage II-IV epithelial ovarian, fallopian tube or primary peritoneal cancer. We report the long-term follow-up results on progression-free survival (PFS) and overall survival (OS). Methods: Patients with stage II to IV ovarian cancer were randomly assigned to receive c-TC (carboplatin AUC 6 and paclitaxel 180 mg/m2 on day 1) or dd-TC (carboplatin AUC 6 on day 1 and paclitaxel 80 mg/m2 on day 1, 8, 15). The treatments were repeated every 3 weeks for six cycles; in responding patients, additional three cycles were administered. Results: The analysis included eligible 631 patients. At 6.4 years of median follow-up, there continues to be a highly statistically significant improvement in median PFS in favor of the dd-TC group compared with the c-TC group (28.1 vs. 17.5 months, hazard ratio [HR] 0.75, 95% CI, 0.62-0.91; P=0.0037). Median survival has not yet been reached in the dd-TC group, and OS at 5 years was higher in the dd-TC group than the c-TC group (58.6% vs. 51.0%, HR 0.79, 95% CI, 0.63-0.99; P =0.0448). Conclusions: The dd-TC improves long-term PFS and OS in patients with advanced epithelial ovarian cancer.