Open Access

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)

  • Authors:
    • Masanori Kotake
    • Toru Aoyama
    • Yoshinori Munemoto
    • Kenji Doden
    • Masato Kataoka
    • Kenji Kobayashi
    • Genichi Nishimura
    • Hidehito Fujita
    • Keishi Nakamura
    • Akira Takehara
    • Chihiro Tanaka
    • Junichi Sakamoto
    • Naoki Nagata
    • Koji Oba
    • Ken Kondo
  • View Affiliations

  • Published online on: December 14, 2016     https://doi.org/10.3892/ol.2016.5505
  • Pages: 747-753
  • Copyright: © Kotake et al. This is an open access article distributed under the terms of Creative Commons Attribution License.

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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 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.
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February-2017
Volume 13 Issue 2

Print ISSN: 1792-1074
Online ISSN:1792-1082

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Spandidos Publications style
Kotake M, Aoyama T, Munemoto Y, Doden K, Kataoka M, Kobayashi K, Nishimura G, Fujita H, Nakamura K, Takehara A, Takehara A, et al: 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). Oncol Lett 13: 747-753, 2017
APA
Kotake, M., Aoyama, T., Munemoto, Y., Doden, K., Kataoka, M., Kobayashi, K. ... Kondo, K. (2017). 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). Oncology Letters, 13, 747-753. https://doi.org/10.3892/ol.2016.5505
MLA
Kotake, M., Aoyama, T., Munemoto, Y., Doden, K., Kataoka, M., Kobayashi, K., Nishimura, G., Fujita, H., Nakamura, K., Takehara, A., Tanaka, C., Sakamoto, J., Nagata, N., Oba, K., Kondo, K."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)". Oncology Letters 13.2 (2017): 747-753.
Chicago
Kotake, M., Aoyama, T., Munemoto, Y., Doden, K., Kataoka, M., Kobayashi, K., Nishimura, G., Fujita, H., Nakamura, K., Takehara, A., Tanaka, C., Sakamoto, J., Nagata, N., Oba, K., Kondo, K."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)". Oncology Letters 13, no. 2 (2017): 747-753. https://doi.org/10.3892/ol.2016.5505