469PD - Phase III trial of 24 weeks vs. 48 weeks capecitabine adjuvant chemotherapy for patients with stage III colon cancer: Final results of JFMC37-0801

Date 10 October 2016
Event ESMO 2016 Congress
Session Gastrointestinal tumours, colorectal
Topics Cytotoxic agents
Colon and Rectal Cancer
Therapy
Biological therapy
Presenter Shigeki Yamaguchi
Citation Annals of Oncology (2016) 27 (6): 149-206. 10.1093/annonc/mdw370
Authors S. Yamaguchi1, K. Kunieda2, T. Sato3, Y. Naramoto4, M. Kobayashi5, Y. Ogata6, T. Furuhata7, Y. Takii8, M. Kusunoki9, Y. Maehara10, K. Koda11, K. Okuno12, M. Ohno13, H. Mishima14, S. Sadahiro15, C. Hamada16, J. Sakamoto17, S. Saji17, N. Tomita18
  • 1Gastroenterological Surgery, Saitama Medical University International Medical Center, 350-1298 - Hidaka/JP
  • 2Surgery, Gifu Prefectural General Medical Center, Gifu/JP
  • 3Surgery, Yamagata Prefectural Central Hospital, Yamagata/JP
  • 4Surgery, Kawasaki Medical School Hospital, Okayama/JP
  • 5Human Health And Medical Sciences, Kochi Medical School Hospital Cancer Treatment Center, Kochi/JP
  • 6Cancer Center, Kurume University, Kurume/JP
  • 7Surgery, Sapporo Medical University School of Medicine, Sapporo/JP
  • 8Surgery, Niigata Cancer Center Hospital, Niigata/JP
  • 9Surgery, Mie University Graduate School of Medicine, Tsu/JP
  • 10Surgery And Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka/JP
  • 11Surgery, University of Teikyo Teikyo University Chiba Medical Center, Ichihara/JP
  • 12Surgery, Kindai University Faculty of Medicine, Osaka/JP
  • 13Surgery, Hyogo Prefectural Kaibara Hospital, Kaibara/JP
  • 14Cancer Center, Aichi Medical University, Nagakute/JP
  • 15Surgery, Tokai University, Isehara/JP
  • 16Graduate School Of Engineering, Tokyo University of Science, Tokyo/JP
  • 17Director, Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo/JP
  • 18Surgery, Hyogo College of Medicine, Nishinomiya/JP

Abstract

Background

JFMC37-0801 study was planned to offer superiority of 48 weeks treatment of capecitabine adjuvant chemotherapy to 24 weeks conventional treatment with respect to the primary endpoint of disease free survival (DFS) in patients with stage III colon and rectosigmoid cancer. Here, we report the final results of this study.

Methods

Patients with curatively resected stage III colon and rectosigmoid cancer (PS, 0 to 1; age, 20 to 79 years; no other therapy) were randomly assigned to receive capecitabine (1,250 mg/m2/day) for 14 out of 21 days for 24 weeks, 8 courses (Control (C) arm) or for 48 weeks, 16 courses (Study (S) arm). The primary endpoint was the DFS, and the secondary endpoints were overall survival (OS) and relapse free survival (RFS). Patient information was fixed in March 2016.

Results

At the time of this final analysis, median follow-up was 60 months with 434 DFS events out of 1304 (C: 654, S: 650) pts. The 3-year and 5-year DFS for the primary endpoint was 75.3%, 68.7% in the S arm and 70.0%, 65.3% in the C arm, respectively (p = 0.068, HR = 0.866, 95%CI: 0.717-1.046). The 5-year OS was 87.6% in the S arm and 83.2% in the C arm (p = 0.0159, HR = 0.737, 95%CI: 0.557-0.975). The 5-year RFS was 74.1% in the S arm and 69.3% in the C arm (p = 0.0207, HR = 0.808, 95%CI: 0.658-0.992). Overall grade 3-4 adverse events of S arm were comparable with those of C arm except increasing hand-foot syndrome.

Conclusions

DFS superiority in 48 weeks treatment of capecitabine adjuvant chemotherapy was not demonstrated in patients with stage III colon cancer. However, p-values of OS and RFS comparing 48 weeks treatment with 24 weeks treatment were less than 0.025. Thus, with regard to the optimal duration of adjuvant chemotherapy for stage III colon cancer, further investigation was considered to be needed.

Clinical trial identification

Legal entity responsible for the study

N/A

Funding

Japanese Foundation for Multidisciplinary Treatment of Cancer

Disclosure

All authors have declared no conflicts of interest.