182P - Phase II clinical trial of adjuvant chemotherapy with mFOLFOX6/XELOX for stage III colon cancer in Japanese subjects

Date 19 December 2015
Event ESMO Asia 2015 Congress
Session Poster presentation 1
Topics Anticancer Agents
Colon and Rectal Cancer
Biological Therapy
Presenter Takeshi Yamada
Citation Annals of Oncology (2015) 26 (suppl_9): 42-70. 10.1093/annonc/mdv523
Authors T. Yamada1, K. Koda2, K. Ishibashi3, H. Kato4, G. Nishimura5, S. Ooki6, K. Yoshimatsu7, E. Uchida8, H. Kan8, C. Kosugi9, S. Tanaka10, R. Kato11, S. Kouketsu12, H. Nakajima13, H. Maekawa14, M. Kobayashi15, M. Tsubaki16, M. Yokoyama17, K. Tanakaya18, H. Ishida3
  • 1Department Of Gastrointestinal And Hepato-biliary-pancreatic Surgery, Nippon Medical School Main Hospital, 113-8602 - Tokyo/JP
  • 2Surgery, University of Teikyo Teikyo University Chiba Medical Center, Ichihara/JP
  • 3Digestive Tract And General Surgery, Saitama Medical Center, Saitama Medical University, 350-8550 - Kawagoe/JP
  • 4Surgery 1, Dokkyo Medical University, Tochigi/JP
  • 5Surgery, Kanazawa Red Cross Hospital, Kanazawa/JP
  • 6Organ Regulatory Surgery, Fukushima Medical University, Fukushima/JP
  • 7Surgery, Department of Surgery, Tokyo Women's Medical Ubiversity, Medical Center East, Tokyo/JP
  • 8Department Of Gastrointestinal And Hepato-biliary-pancreatic Surgery, Nippon Medical School Main Hospital, Tokyo/JP
  • 9Department Of Surgery, University of Teikyo Teikyo University Chiba Medical Center, 299-0111 - Ichihara/JP
  • 10Surgery, Matsuda Hospital, Shizuoka/JP
  • 11Surgery, Sakura Medical Center, School of Medicine, Faculty of Medicine, Toho University, Sakura/JP
  • 12First Department Of Surgery, Koshigaya Hospital, Dokkyo University School of Medicine, Koshigaya/JP
  • 13Oncology, Ageo Central General Hospital, Ageo/JP
  • 14Surgery, Shizuoka Hospital School of Medicine, Juntendo University, Isunokuni/JP
  • 15Cancer Treatment Center, Kochi Medical School Hospital, Nangoku/JP
  • 16Surgery, Yuai Memorial Hospital, Koga/JP
  • 17Surgery, Higashimatsuyama Medical Association Hospital, Higashimatsuyama/JP
  • 18Surgery, National Hospital Organization, Iwakuni Clinical Center., Iwakuni/JP



In Japan, the main adjuvant chemotherapy used for colon cancer is oral 5-fluorouracil (5-FU) because the 5 year survival rate for colon cancer is good (Stage IIIA; 77.3%, Stage IIIB; 68.1%). Although the safety and efficacy of FOLFOX4 for stage III colon cancer have been reported (MOSAIC trial), there are insufficient safety data to justify the use of mFOLFOX6 and XELOX as adjuvant chemotherapy for stage III colon cancer in Japanese patients. We evaluated the efficacy, feasibility and safety of adjuvant mFOLFOX6 or XELOX in patients with Stage III colon cancer.


Inclusion criteria were as follows: 1) Stage III colon cancer; 2) age 20–75 years; 3) ECOG PS 0 or 1; and 4) curative resection. Physicians selected 12 courses of mFOLFOX6 or 8 courses of XELOX.


One hundred and thirty-two patients were enrolled in this study; however, two were ineligible. The study thus included 80 men and 50 women, 88 patients with stage IIIa and 42 with stage IIIb, 44 patients with right and 86 with left colon cancer. One hundred and eighteen patients (91%) underwent D3 lymph node dissection, the median number of dissected lymph nodes being 19. Seventy-three patients received mFOLFOX6 and 57 patients XELOX. The median age was 65 years. The rate of chemotherapy completion was 69.2% (N = 90). The reasons for discontinuation were adverse events (N = 31), patient refusal to continue (N = 8), and recurrence (N = 1). The median number of cycles of mFOLFOX6 was 12 (1–12) and of XELOX was eight (1–8). The median oxaliplatin relative dose intensity was 80.3% (14.8–100%). The overall rate of grade 3–4 toxicity was 40%, of grade 3–4 neutropenia 28.5%, and of grade 3 neuropathy 4.6%. The relative dose intensity of oxaliplatin of the patients treated with XELOX tended to be higher than that of the patients treated with FOLFOX (P = 0.06). The incidences of G3–4 neutropenia (P = 0.04) and G2 infusion-related reactions (P = 0.002) in the patients treated with FOLFOX were significantly higher than in those treated with XELOX.


mFOLFOX6 and XELOX are safe and feasible for adjuvant chemotherapy of Japanese patients with Stage III colon cancer. In these patients, XELOX may be safer than FOLFOX. Though, this clinical study was not randomized trial with small number of patients.

Clinical trial identification


All authors have declared no conflicts of interest.