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Gastrointestinal tumours, colorectal

1873 - Randomized phase III study of adjuvant chemotherapy with S-1 versus capecitabine in patients with stage III colorectal cancer: Updated results of Japan Clinical Oncology Group study (JCOG0910)

Date

10 Sep 2017

Session

Gastrointestinal tumours, colorectal

Topics

Cytotoxic Therapy;  Colon and Rectal Cancer

Presenters

Tetsuya Hamaguchi

Citation

Annals of Oncology (2017) 28 (suppl_5): v158-v208. 10.1093/annonc/mdx393

Authors

T. Hamaguchi1, Y. Shimada1, J. Mizusawa2, T. Sato3, T. Kato4, K. Takahashi5, K. Sugihara6, Y. Saida7, H. Ike8, K. Hase9, T. Masaki10, M. Shiozawa11, A. Sugita12, J. Nishimura13, Y. Munakata14, S. Ikeda15, K. Nakamura2, H. Fukuda2

Author affiliations

  • 1 Gastrointestinal Medical Oncology, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 2 Jcog Data Center/operations Office, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 3 Surgery, Yamagata Prefectural Central Hospital, Yamagata/JP
  • 4 Department Of Surgery, Kansai Rosai Hospital, 660-8511 - Hyogo/JP
  • 5 Surgery, Tokyo Metropolitan Cancer and Infectious Diease Center Komagome Hospital, Tokyo/JP
  • 6 Gastrointestinal Surgery, Tokyo Medical and Dental University, 113-8519 - Tokyo/JP
  • 7 Department Of Surgery, Toho University Ohashi Medical Center, 153-8515 - Tokyo/JP
  • 8 Surgery, Saiseikai Yokohamashi Nanbu Hospital, Kanagawa/JP
  • 9 Surgery, National Defence Medical College, Saitama/JP
  • 10 Surgery, Kyorin University, Tokyo/JP
  • 11 Gastrointestinal Surgery, Kanagawa Cancer Center, Kanagawa/JP
  • 12 Surgery, Yokohama Municipal Citizen's Hospital, Kanagawa/JP
  • 13 Surgery, Nagaoka Chuo General Hospital, Niigata/JP
  • 14 Surgery, Nagano Municipal Hospital, Nagano/JP
  • 15 Surgery, Hiroshima Prefectural Hospital, Hiroshima/JP
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Resources

Abstract 1873

Background

We demonstrated that the second planned interim analysis (median follow-up, 23.7 months) of the JCOG0910 failed to show non-inferiority of adjuvant S-1 to capecitabine in disease-free survival (DFS: relapse, second malignancy, death are events) at ASCO2015 (abstract # 3512), and the results were opened by the recommendation of JCOG Data and Safety Monitoring Committee. We updated the follow-up data to confirm the conclusion at the interim analysis.

Methods

Key eligibility criteria were: stage III, colorectal adenocarcinoma except for lower rectal cancer, R0 with D2/3 lymph node dissection. Patients were randomized to 8 courses of capecitabine (1,250 mg/m2 twice daily, days 1–14, every 3 weeks) or 4 courses of S-1 (40 mg/m2 twice daily, days 1–28, every 6 weeks). Primary endpoint was DFS. Planned sample size was 1,550 in order to provide 80% power with a non-inferiority margin at a hazard ratio (HR) of 1.24 and 1-sided α = 0.05. This trial is registered with UMIN-CTR, #UMIN000003272.

Results

1,564 patients were randomized to capecitabine (n = 782) or S-1 (n = 782). At the end of the follow-up period of 3 years, 69% of required events (368/535) were observed, with a median follow-up for all randomized patients of 4.13 years, 3-year DFS was 81.7% (95% CI, 78.8 - 84.2%) in capecitabine and 78.3% (75.2 - 81.0%) in S-1. The HR of DFS was 1.22 (95% CI, 1.00–1.50) and the non-inferiority of S-1 was not demonstrated (P for non-inferiority = 0.448). Three-year relapse-free survival (RFS: relapse, death are events) was 84.6% in capecitabine and 81.5% in S-1. The HR of RFS was also 1.21 (95% CI, 0.96–1.53). Three-year overall survival (OS) was 96.3% in capecitabine and 95.4% in S-1. The HR of OS was 1.18 (95% CI, 0.83–1.68). In the subgroup analyses, no significant interactions were identified between the major baseline characteristics.

Conclusions

These updated results confirmed that S-1 could not be demonstrated to be non-inferior to capecitabine in DFS. Adjuvant capecitabine remains the standard treatment and S-1 is not recommended.

Clinical trial identification

#UMIN000003272

Legal entity responsible for the study

Japan Clinical Oncology Group

Funding

National Cancer Center and Ministry of Health, Labour and Welfare of Japan

Disclosure

T. Hamaguchi: Honoraria from Chugai, Merck Serono, Takeda, Yakult, and Taiho. Reserach funding (to institute) from Dainippon Sumitomo, Sanofi, NanoCarrier, Taiho, Ono, Daiichi Sankyo, Teijin, and MSD. Advisory role for NanoCarrier. Y. Shimada: Research funding (to institute) from Taiho, Ili Lilly, Merck Serono, and MSD. Honoraria from Taiho, Chugai, Ili Lilly, Ono, Novartis, Bayer, and Merck Serono. T. Kato: Honoraria from Chugai, Takeda, Eli Lilly, Bayer, Sanofi, and Yakult. K. Sugihara: Research fundings (to institute) from Chugai, Taiho, and Takeda. Honoraria from Chugai, Taiho, Yakult, Merck Serono, Bristol-Myers Squibb, and Takeda. Y. Saida: Honoraria from Chugai, Taiho, Merck Serorno, and Takeda. Research funding (to institute) from Chugai, Taiho, Yakult and Takeda. T. Masaki: Honoraria from Chugai, Taiho, Yakult, and Kyorin Pharmaceutical Campany. K. Nakamura: Honorarium from Taiho. H. Fukuda: Honoraria from Taiho and Chugai. All other authors have declared no conflicts of interest.

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