title: 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).
abstract: 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 syears) received a biweekly intravenous infusion of cetuximab (500 mg/m2on day 1) followed by FOLFOX-6 (2-hour oxaliplatin 85 mg/m2infusion on day 1 in tandem with a 2-h leucovorin 200 mg/m2infusion on days 1 and 2, and 5-FU as a 400 mg/m2bolus followed by a 46-hour 2,400 mg/m2infusion 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.
authors.affiliation: Department of Surgery, Kouseiren Takaoka Hospital, Takaoka, Toyama 933-8555, Japan.
authors.forename: Masanori
authors.initials: M
authors.lastname: Kotake
authors.affiliation: Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Kanagawa 241-8515, Japan.
authors.forename: Toru
authors.initials: T
authors.lastname: Aoyama
authors.affiliation: Department of Surgery, Fukui Saiseikai Hospital, Fukui 918-8503, Japan.
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Munemoto
authors.affiliation: Department of Surgery, Fukui Prefectural Hospital, Fukui 910-8526, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Doden
authors.affiliation: Department of Surgery, National Hospital Organization (NHO) Nagoya Medical Center, Nagoya, Aichi 460-0001, Japan.
authors.forename: Masato
authors.initials: M
authors.lastname: Kataoka
authors.affiliation: Department of Surgery, Matsunami General Hospital, Gifu 501-6062, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Kobayashi
authors.affiliation: Department of Surgery, Japanese Red Cross Kanazawa Hospital, Kanazawa 921-8162, Japan.
authors.forename: Genichi
authors.initials: G
authors.lastname: Nishimura
authors.affiliation: Department of Surgery, Kanazawa Medical University, Uchinada, Kanazawa 920-0293, Japan.
authors.forename: Hidehito
authors.initials: H
authors.lastname: Fujita
authors.affiliation: Department of Surgery, Kanazawa University Hospital, Kanazawa 920-8641, Japan.
authors.forename: Keishi
authors.initials: K
authors.lastname: Nakamura
authors.affiliation: Department of Surgery, Japanese Red Cross Toyama Hospital, Toyama 930-0859, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Takehara
authors.affiliation: Department of Surgery, Gifu Prefectural General Medical Center, Gifu 500-8717, Japan.
authors.forename: Chihiro
authors.initials: C
authors.lastname: Tanaka
authors.affiliation: Department of Surgery, Tokai Central Hospital, Kakamigahara, Gifu 504-8601, Japan.
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
authors.affiliation: Department of Surgery, Kitakyushu General Hospital, Kitakyushu, Fukuoka 802-8517, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Nagata
authors.affiliation: Department of Biostatistics, The University of Tokyo, Tokyo 113-8654, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Oba
authors.affiliation: Department of Surgery, National Hospital Organization (NHO) Nagoya Medical Center, Nagoya, Aichi 460-0001, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Kondo
keywords: Cetuximab; FOLFOX; colorectal cancer; mCRC