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The COMET Open-label Phase II Study of Neoadjuvant FOLFOX or XELOX Treatment Combined with Molecular Targeting Monoclonal Antibodies in Patients with Resectable Liver Metastasis of Colorectal Cancer

  • Hepatobiliary Tumors
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

An Erratum to this article was published on 19 September 2016

Abstract

Background

Advantages of neoadjuvant chemotherapy combined with monoclonal antibodies for treating patients with resectable colorectal cancer liver metastasis (CLM) have not been established. The purpose of this study was to evaluate the efficacy and safety of oxaliplatin-based regimen (FOLFOX or XELOX) plus monoclonal antibodies (cetuximab or bevacizumab) treatment in patients with resectable CLM.

Methods

A single-arm, open-label, multicenter, phase II trial was conducted for patients aged ≥ 20 years with resectable and untreated CLM. Patients received preoperative FOLFOX (6 cycles) or XELOX (4 cycles). Cetuximab or bevacizumab was administered to patients with wild-type or mutated KRAS codons 12 and 13, respectively. The primary endpoint was progression-free survival (PFS).

Results

Between January 2010 and June 2012, 47 patients were enrolled from 12 institutions. Wild-type or mutant KRAS sequences were examined in 32 and 15 patients, respectively. Twenty-one (45 %) patients experienced Grades 3/4 adverse events, and 55 % of all patients responded to therapy. The sizes of tumors of patients in the wild-type KRAS group were significantly reduced compared with those of the mutant KRAS group. The overall rates of liver resection and postoperative morbidity were 83 and 14 %, respectively, and the median PFS was 15.6 months. The median PFS times of the KRAS wild-type and mutant groups were 22.5 months and 10.5 months, respectively.

Conclusions

Neoadjuvant therapy using FOLFOX/XELOX combined with monoclonal antibodies did not improve PFS, although it was administered safely and had less adverse effects after liver resection.

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Funding

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Author information

Author notes

    Authors and Affiliations

    1. Department of Surgery, Nagoya National Hospital, Nagoya, Japan

      Masato Kataoka MD & Ken Kondo MD

    2. Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine, Nagoya, Japan

      Mitsuro Kanda MD, Nao Takano MD & Haruyoshi Tanaka MD

    3. Department of Surgery, Konan Kosei Hospital, Konan, Japan

      Kiyoshi Ishigure MD

    4. Department of Surgery, Fujita Health University School of Medicine, Aichi, Japan

      Hiroshi Matsuoka MD

    5. Department of Surgery, Tosei Hospital, Seto, Japan

      Yusuke Sato MD

    6. Department of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu, Japan

      Takao Takahashi MD

    7. Department of Surgery, Gifu Prefectural General Medical Center, Gifu, Japan

      Chihiro Tanaka MD

    8. Department of Surgery, Gifu Prefectural Tajimi Hospital, Tajimi, Japan

      Tomohiro Deguchi MD

    9. Department of Surgery, Toyohashi Municipal Hospital, Toyohashi, Japan

      Yoshihisa Shibata MD

    10. Department of Gastroenterological Surgery, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan

      Mikinori Sato MD

    11. Department of Surgery, Yokoyama Hospital for Gastroenterological Diseases, Nagoya, Japan

      Hitoshi Inagaki MD

    12. Department of Gastroenterological Surgery, Aichi Cancer Center Aichi Hospital, Okazaki, Japan

      Takanori Matsui MD

    13. Department of Surgery, Saiseikai Matsusaka General Hospital, Matsusaka, Japan

      Akinori Kondo MD

    14. Tokai Central Hospital, Gifu, Japan

      Junichi Sakamoto MD

    15. Department of Biostatistics, School of Public Health, Tokyo University Graduate School of Medicine, Tokyo, Japan

      Koji Oba MD

    16. Interfaculty Initiative in Information Studies, Tokyo University, Tokyo, Japan

      Koji Oba MD

    Authors
    1. Masato Kataoka MD
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    2. Mitsuro Kanda MD
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    Corresponding author

    Correspondence to Mitsuro Kanda MD.

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    Disclosure

    Junichi Sakamoto serves as an advisor to Takeda Pharmaceutical Company Limited and received lecture fees from Tsumura Co., Ltd.

    Additional information

    Masato Kataoka and Mitsuro Kanda have contributed equally to this work.

    An erratum to this article is available at http://dx.doi.org/10.1245/s10434-016-5593-5.

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    Kataoka, M., Kanda, M., Ishigure, K. et al. The COMET Open-label Phase II Study of Neoadjuvant FOLFOX or XELOX Treatment Combined with Molecular Targeting Monoclonal Antibodies in Patients with Resectable Liver Metastasis of Colorectal Cancer. Ann Surg Oncol 24, 546–553 (2017). https://doi.org/10.1245/s10434-016-5557-9

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    • DOI: https://doi.org/10.1245/s10434-016-5557-9

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