TY - JOUR AB - The current phase II study investigated the efficacy and safety of biweekly cetuximab combined with standard oxaliplatin‑based chemotherapy [infusional 5‑fluorouracil (5‑FU), leucovorin, and oxaliplatin (FOLFOX‑6)] in the first‑line treatment of KRAS wild‑type metastatic colorectal cancer (mCRC). Sixty patients with a median age of 64 years (range, 38‑82 years) received a biweekly intravenous infusion of cetuximab (500 mg/m2 on day 1) followed by FOLFOX‑6 (2‑hour oxaliplatin 85 mg/m2 infusion on day 1 in tandem with a 2‑h leucovorin 200 mg/m2 infusion on days 1 and 2, and 5‑FU as a 400 mg/m2 bolus followed by a 46‑hour 2,400 mg/m2 infusion on days 1‑3). Patient response rate was 70%, with 95% disease control rates. The median progression‑free survival was 13.8 months. Thirteen patients (21.7%) were able to undergo resection of previously unresectable metastases, with the aim of curing them. The median follow‑up was 22.7 months, and median overall survival was 31.0 months. Cetuximab did not increase FOLFOX‑6 toxicity and was generally well tolerated. The results of the current study demonstrate that the combination of biweekly cetuximab with FOLFOX‑6 was well tolerated and had a manageable safety profile for the first‑line treatment of KRAS wild‑type metastatic colorectal cancer. Efficacy was comparable to other treatment regimens. The results support the administration of biweekly cetuximab in combination with FOLFOX‑6, which may be more convenient and provide treatment flexibility in this setting for patients with metastatic colorectal cancers. AD - Department of Surgery, Kouseiren Takaoka Hospital, Takaoka, Toyama 933‑8555, Japan Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Kanagawa 241‑8515, Japan Department of Surgery, Fukui Saiseikai Hospital, Fukui 918‑8503, Japan Department of Surgery, Fukui Prefectural Hospital, Fukui 910‑8526, Japan Department of Surgery, National Hospital Organization (NHO) Nagoya Medical Center, Nagoya, Aichi 460‑0001, Japan Department of Surgery, Matsunami General Hospital, Gifu 501‑606, Japan Department of Surgery, Japanese Red Cross Kanazawa Hospital, Kanazawa 921‑8162, Japan Department of Surgery, Kanazawa Medical University, Uchinada, Kanazawa 920‑0293, Japan Department of Surgery, Kanazawa University Hospital, Kanazawa 920‑8641, Japan Department of Surgery, Japanese Red Cross Toyama Hospital, Toyama 930‑0859, Japan Department of Surgery, Gifu Prefectural General Medical Center, Gifu 500‑8717, Japan Department of Surgery, Tokai Central Hospital, Kakamigahara, Gifu 504‑8601, Japan Department of Surgery, Kitakyushu General Hospital, Kitakyushu, Fukuoka 802‑8517, Japan Department of Biostatistics, The University of Tokyo, Tokyo 113‑8654, Japan AU - Kotake,Masanori AU - Aoyama,Toru AU - Munemoto,Yoshinori AU - Doden,Kenji AU - Kataoka,Masato AU - Kobayashi,Kenji AU - Nishimura,Genichi AU - Fujita,Hidehito AU - Nakamura,Keishi AU - Takehara,Akira AU - Tanaka,Chihiro AU - Sakamoto,Junichi AU - Nagata,Naoki AU - Oba,Koji AU - Kondo,Ken DA - 2017/02/01 DO - 10.3892/ol.2016.5505 EP - 753 IS - 2 JO - Oncol Lett KW - Cetuximab FOLFOX colorectal cancer mCRC PY - 2017 SN - 1792-1074 1792-1082 SP - 747 ST - Multicenter phase II study of infusional 5‑fluorouracil (5‑FU), leucovorin, and oxaliplatin, plus biweekly cetuximab as first‑line treatment in patients with metastatic colorectal cancer (CELINE trial) T2 - Oncology Letters TI - Multicenter phase II study of infusional 5‑fluorouracil (5‑FU), leucovorin, and oxaliplatin, plus biweekly cetuximab as first‑line treatment in patients with metastatic colorectal cancer (CELINE trial) UR - https://doi.org/10.3892/ol.2016.5505 VL - 13 ER -