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Dose-Dense Paclitaxel Plus Carboplatin Improves Long-Term Survival in Advanced Ovarian Cancer

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Key Points

  • Dose-dense treatment was associated with significantly prolonged progression-free and overall survival in patients with advanced ovarian cancer.
  • Dose-dense treatment was associated with significant improvements in survival in patients with residual disease ≥ 1 cm but not in those with residual disease < 1 cm, and in patients with serous or other histologic subtypes, but not in those with clear cell or mucinous tumors.

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 OncologyNoriyuki 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®.


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