Ovarian Cancer Canada

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Improved Progression-free and Overall Survival: Phase III Trial

In this long-term follow-up of a phase III trial of Japanese patients with stage II–IV ovarian cancer, patients treated with weekly paclitaxel and every 3-week carboplatin had improved progression-free and overall survival when compared with those who received conventional dosing of both paclitaxel and carboplatin on an every 3-week schedule.

Lancet Oncol. 2013 Aug 13;[EPub Ahead of Print], N Katsumata, M Yasuda, S Isonishi, F Takahashi, H Michimae, E Kimura, D Aoki, T Jobo, S Kodama, F Terauchi, T Sugiyama, K Ochiai


Long-Term Results of Dose-Dense Paclitaxel and Carboplatin versus Conventional Paclitaxel and Carboplatin for Treatment of Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (JGOG 3016):   A Randomised, Controlled, Open-Label Trial Trial 


Background: The primary analysis of the JGOG 3016 trial showed that a dose-dense paclitaxel and carboplatin regimen significantly improves progression-free and overall survival compared with the conventional regimen as first-line chemotherapy for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. We report the long-term follow-up results for survival.

Methods: This randomised controlled trial was done at 85 centres in Japan. Patients with stage II–IV ovarian cancer were randomly assigned to receive conventional treatment (carboplatin area under the curve [AUC] 6 mg/mL per min and paclitaxel 180 mg/m2 on day 1) or dose-dense treatment (carboplatin AUC 6 mg/mL per min on day 1 and paclitaxel 80 mg/m2 on days 1, 8, and 15). The treatments were repeated every 3 weeks for six cycles; responding patients had three additional cycles. The randomisation was done centrally by telephone or fax, stratified by residual disease, stage, and histological type. The primary endpoint was progression-free survival; overall survival was a secondary endpoint. Long-term information on adverse events was not collected. Efficacy analyses were by intention to treat.

Findings: 637 patients were enrolled, of whom 631 were analysed (312 assigned to the dose-dense regimen, 319 to the conventional regimen). Median follow-up was 76·8 months (IQR 68·9–85·6). Median progression-free survival was significantly longer in the dose-dense treatment group than in the conventional treatment group (28·2 months [95% CI 22·3–33·8] vs 17·5 months [15·7–21·7]; hazard ratio [HR] 0·76, 95% CI 0·62–0·91; p=0·0037). Median overall survival was 100·5 months (95% CI 65·2–∞) in the dose-dense treatment group and 62·2 months (52·1–82·6) in the conventional treatment group (HR 0·79, 95% CI 0·63–0·99; p=0·039).

Interpretation: 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.


This entry was posted on September 3, 2013 by in Research Updates and tagged , , , .

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