Dose-Dense Paclitaxel Plus Carboplatin Improves Long-Term Survival in Advanced Ovarian Cancer
The primary analysis of the Japanese JGOG 3016 trial showed that dose-dense paclitaxel plus carboplatin significantly improved progression-free and overall survival compared with conventional paclitaxel/carboplatin as first-line treatment in patients with advanced ovarian cancer. In a long-term follow-up of the trial reported in Lancet Oncology, Noriyuki Katsumata, MD, of Nippon Medical School Musashi Kosugi Hospital in Kawasaki and colleagues found that dose-dense treatment was associated with significantly prolonged progression-free and overall survival after a median follow-up of more than 6 years.
Study Details
In the phase III open-label JGOG 3016 trial, 631 patients with stage II to IV epithelial ovarian, fallopian tube, or primary peritoneal cancer were randomized to dose-dense paclitaxel at 80 mg/m2 on days 1, 8, and 15 plus carboplatin AUC 6 mg/mL/min on day 1 (n = 312) or conventional paclitaxel at 180 mg/m2 on day 1 plus carboplatin (n = 319) every 3 weeks for six cycles, with responding patients receiving three additional cycles.
In the initial report of results in 2009, after a median follow-up of 29 months, dose-dense treatment was associated with significant prolongation of progression-free survival (28.0 vs 17.2 months, hazard ratio [HR]= 0.71, P = .0015) and improved 3-year overall survival (72.1% vs 65.1%, HR = 0.75, P = .03).
Survival in Long-Term Follow-up
After a median follow-up of 76.8 months in the long-term analysis, median progression-free survival (28.2 vs 17.5 months, HR = 0.76, P = .0037) and median overall survival (100.5 vs 62.2 months, HR = 0.79, P = .039) were significantly longer in the dose-dense treatment group. Five-year overall survival was 58.7% vs 51.1%.
Median progression-free survival (17.6 vs 12.1 months, HR = 0.71, P = .0029) and overall survival (51.2 vs 33.5 months, HR = 0.75, P = .0027) were significantly increased in patients with residual disease ≥ 1 cm, but not in those with residual disease < 1 cm (median progression-free survival not reached vs 60.9 months, HR = 0.74, P = .08; median overall survival not reached vs not reached, HR = 0.76, P = .23).
Among patients with serous or other histologic subtypes, median progression-free survival (28.7 vs 17.5 months, HR = 0.70, P = .0007) and overall survival (100.5 vs 61.2 months, HR = 0.76, P = .0252) were increased with dose-dense treatment. No significant difference in median progression-free survival (18.7 vs 16.7 months, HR = 1.06, P = .84) or overall survival (not reached vs 62.2 months, HR = 0.92, P = .776) was observed among patients with clear cell or mucinous tumors.
The investigators concluded, “Dose-dense treatment offers better survival than conventional treatment and is a potential new standard of care for first-line chemotherapy for patients with advanced epithelial ovarian cancer.”
Funding for the study was provided by the Japanese Gynecologic Oncology Group and Bristol-Myers Squibb.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
