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

Noriyuki Katsumata, Makoto Yasuda, Seiji Isonishi, Fumiaki Takahashi, Hirofumi Michimae, Eizo Kimura, Daisuke Aoki, Toshiko Jobo, Shoji Kodama, Fumitoshi Terauchi, Toru Sugiyama, Kazunori Ochiai

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Abstract

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. This study is registered with ClinicalTrials.gov, number NCT00226915. 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. Funding: Japanese Gynecologic Oncology Group, Bristol-Myers Squibb.

Original languageEnglish
Pages (from-to)1020-1026
Number of pages7
JournalThe Lancet Oncology
Volume14
Issue number10
DOIs
Publication statusPublished - 2013 Sep

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Fallopian Tubes
Carboplatin
Paclitaxel
Neoplasms
Disease-Free Survival
Therapeutics
Survival
Area Under Curve
Telefacsimile
Drug Therapy
Intention to Treat Analysis
Standard of Care
Random Allocation
Telephone
Ovarian Neoplasms
Japan
Randomized Controlled Trials

ASJC Scopus subject areas

  • Oncology

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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. / Katsumata, Noriyuki; Yasuda, Makoto; Isonishi, Seiji; Takahashi, Fumiaki; Michimae, Hirofumi; Kimura, Eizo; Aoki, Daisuke; Jobo, Toshiko; Kodama, Shoji; Terauchi, Fumitoshi; Sugiyama, Toru; Ochiai, Kazunori.

In: The Lancet Oncology, Vol. 14, No. 10, 09.2013, p. 1020-1026.

Research output: Contribution to journalArticle

Katsumata, Noriyuki ; Yasuda, Makoto ; Isonishi, Seiji ; Takahashi, Fumiaki ; Michimae, Hirofumi ; Kimura, Eizo ; Aoki, Daisuke ; Jobo, Toshiko ; Kodama, Shoji ; Terauchi, Fumitoshi ; Sugiyama, Toru ; Ochiai, Kazunori. / 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. In: The Lancet Oncology. 2013 ; Vol. 14, No. 10. pp. 1020-1026.
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T1 - 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)

T2 - A randomised, controlled, open-label trial

AU - Katsumata, Noriyuki

AU - Yasuda, Makoto

AU - Isonishi, Seiji

AU - Takahashi, Fumiaki

AU - Michimae, Hirofumi

AU - Kimura, Eizo

AU - Aoki, Daisuke

AU - Jobo, Toshiko

AU - Kodama, Shoji

AU - Terauchi, Fumitoshi

AU - Sugiyama, Toru

AU - Ochiai, Kazunori

PY - 2013/9

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N2 - 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. This study is registered with ClinicalTrials.gov, number NCT00226915. 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. Funding: Japanese Gynecologic Oncology Group, Bristol-Myers Squibb.

AB - 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. This study is registered with ClinicalTrials.gov, number NCT00226915. 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. Funding: Japanese Gynecologic Oncology Group, Bristol-Myers Squibb.

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