P-0259 - Safety analysis of FOLFOX as adjuvant chemotherapy for stage III colon cancer in North Japan multicenter phase II study (NORTH/HGCSG1003)

Date 28 June 2014
Event World GI 2014
Session Poster Session
Topics Anti-Cancer Agents & Biologic Therapy
Colon Cancer
Presenter Norihiko Takahashi
Citation Annals of Oncology (2014) 25 (suppl_2): ii14-ii104. 10.1093/annonc/mdu165
Authors N. Takahashi1, M. Tateyama2, T. Shichinohe3, N. Nishimoto4, T. Sasaki5, Y. M. Ito6, T. Kusumi7, F. Nakamura8, T. Miyagishima9, I. Iwanaga10, K. Hatanaka11, K. Oomori12, K. Misawa13, N. Senmaru14, K. Iwai15, M. Koike16, T. Shinohara17, T. Fukushima18, K. Ohno19
  • 1Department of Gastroenterological Surgery I, Hokkaido University Hospital, Sapporo/JP
  • 2Department of Internal Medicine, Tomakomai Nisshou Hospital, Tomakomai/JP
  • 3Department of Gastroenterological Surgery II, Hokkaido University Hospital, Sapporo/JP
  • 4Translational Research and Clinical Trial Center, Hokkaido University Hospital, Sapporo/JP
  • 5Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo/JP
  • 6Department of Biostatistics, Hokkaido University Graduate School of Medicine, Sapporo/JP
  • 7Department of Surgery, Keiyukai Sapporo Hospital, Sapporo/JP
  • 8Department of Surgery, Teine Keijinkai Hospital, Sapporo/JP
  • 9Department of Internal Medicine, Kushiro Rosai Hospital, Kushiro/JP
  • 10Department of Gastroenterology, Japanese Red Cross Kitami Hospital, Kitami/JP
  • 11Department of Gastroenterology, Hakodate Municipal Hospital, Hakodate/JP
  • 12Department of Surgery, Keiwakai Ebetsu Hospital, Ebetsu/JP
  • 13Department of Surgery, Sapporo City General Hospital, Sapporo/JP
  • 14Department of Surgery, Steel Memorial Muroran Hospital, Muroran/JP
  • 15Department of Surgery, Oji General Hospital, Tomakomai/JP
  • 16Department of Surgery, KKR Sapporo Medical Center, Sapporo/JP
  • 17Department of Gastroenterological Surgery, Hokkaido Cancer Center, Sapporo/JP
  • 18Department of Surgery, Chitose City Hospital, Chitose/JP
  • 19Department of Surgery, Obihiro Kosei-General Hospital, Obihiro/JP



Oxaliplatin-containing regimen is a standard adjuvant chemotherapy for resected stage III colon cancer. Oxaliplatin-containing regimens were investigated for their efficacy in patients with resected stage III colon cancer in MOSAIC and XELOXA studies. Since these two international randomized studies were performed outside of Japan, we conducted a phase II study (NORTH/HGCSG1003) to assess the efficacy and safety of oxaliplatin in combination with 5-FU/l-LV as adjuvant chemotherapy in Japanese patients with resected stage III colon cancer.


This phase II study enrolled patients with resected stage III colon cancer. Patients received 12 biweekly cycles of oxaliplatin 85 mg/m2 on d1, with l-leucovorin 100 mg/m2, 5-FU 400 mg/m2 bolus IV, then 22-hr IV 5-FU 600 mg/m2 on d1 and 2 (FOLFOX4), or with l-leucovorin 200 mg/m2, 5-FU 400 mg/m2 bolus IV on d1, then 46-hr IV 5-FU 2400 mg/m2 starting on d1 (mFOLFOX6). We assumed an expected 3-year disease-free survival (DFS) rate of 81.2%, which was based on our retrospective analysis from 205 patients that fluoropyrimidine monotherapy showed 3-year DFS rate of 74.3% and on the result of MOSAIC study that the addition of oxaliplatin to LV5FU2 regimen increased 3-year DFS rate by 6.9%. The sample size was determined to be 243 patients, with one-side alpha of 0.05, a power of 0.90. The primary endpoint was DFS. Secondary endpoints included overall survival (OS) and safety.


From September 2010 to March 2013, 273 patients were enrolled at 28 institutions. The safety analysis included 265 patients who received FOLFOX. Patient characteristics were as follows: median age of 65 years (range: 33-84); Male/female: 131/134; PS 0/1:258/7; stage IIIa/IIIb: 201/64; colon/rectosigmoid: 213/52. The most common grade 3-4 adverse events were neutrophil count decreased (48.1%), platelet count decreased (2.3%), paresthesia (0%), peripheral sensory neuropathy (6.0%), allergic reaction (0.8%). There was no treatment-related death.


In Japanese patients with stage III colon cancer, FOLFOX is a well-tolerable regimen as adjuvant chemotherapy.