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A Multicenter Phase II Trial of mFOLFOX6 Plus Bevacizumab to Treat Liver-Only Metastases of Colorectal Cancer that are Unsuitable for Upfront Resection (TRICC0808)

  • Colorectal Cancer
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

A phase II clinical trial was conducted on colorectal cancer patients with only liver metastases (focal diameter exceeds 5 cm or the number of liver metastases is ≥5; H2·H3) to evaluate the liver resection rate and safety after 6 cycles of mFOLFOX6+bevacizumab (BV) therapy.

Methods

mFOLFOX6+BV therapy was applied for 6 cycles to the patients with H2·H3 liver only metastasis. Hepatectomy was considered after the sixth cycle as a rule, and was performed if possible. The primary endpoint was the curative hepatectomy rate (R0 resection rate).

Results

Forty-six patients were registered and 45 patients were included in the efficacy analysis. Of the 19 patients rated as unresectable before therapy, 18 completed 6 cycles of mFOLFOX6+BV therapy and subsequently underwent hepatectomy (16 were R0-resected). Of the 26 initially unresectable patients, 6 underwent hepatectomy (4 were RO-resected). The overall R0 resection rate was 44.4% (20/45). Chemotherapy-associated grade 3 or higher adverse events included neutrophil decreased (17.4%) and leukocyte decreased (8.7%), fatigue (6.5%) etc. Only hypertension (6.5%) and venous thromboembolism (2.2%) were BV-associated grade 3 or higher adverse events. Among the 25 patients who underwent hepatectomy, intraoperative/postoperative complications included grade 3 wound infections (2 cases), biloma, delayed wound healing and intraperitoneal abscess (each 1 case).

Conclusions

In colorectal cancer patients with liver-only metastases, mFOLFOX6+ BV therapy yielded a high hepatectomy rate and a high percentage of initially unresectable and subsequently resectable cases. The chemotherapy associated adverse events and hepatectomy complications were both within acceptable ranges.

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Acknowledgment

The authors express their gratitude to the 25 facilities for their cooperation with case registration.

Author information

Authors and Affiliations

  1. Department of Translational Oncology, Graduate School, Tokyo Medical and Dental University, Tokyo, Japan

    Hiroyuki Uetake MD, PhD & Megumi Ishiguro MD, PhD

  2. Department of Surgery, Tokyo Metropolitan Hiroo Hospital, Tokyo, Japan

    Masamichi Yasuno MD, PhD

  3. Department of Surgery II, Tokyo Women’s Medical University, Tokyo, Japan

    Shingo Kameoka MD, PhD

  4. Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan

    Yasuhiro Shimada MD, PhD

  5. Colorectal Surgical Division, Department of Surgery, Tokyo Metropolitan Cancer and Infectious Disease Center, Komagome Hospital, Tokyo, Japan

    Keiichi Takahashi MD, PhD

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

    Toshiaki Watanabe MD, PhD

  7. Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan

    Kei Muro MD, PhD

  8. Department of Gastroenterological Surgery, Graduate School of Medical Science, Kumamoto University, Kumamoto, Japan

    Hideo Baba MD, PhD

  9. Department of Surgery, National Defense Medical College, Tokorozawa, Japan

    Junji Yamamoto MD, PhD

  10. Gastroenterological Center, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan

    Nobuyuki Mizunuma MD, PhD

  11. Department of Surgery, Osaka General Medical Center, Osaka, Japan

    Hiroshi Tamagawa MD, PhD

  12. Department of Surgery, Iwate Prefectural Central Hospital, Morioka, Japan

    Izumi Mochizuki MD, PhD

  13. Gastrointestinal Surgery Division, Shizuoka Cancer Center, Shizuoka, Japan

    Yusuke Kinugasa MD, PhD

  14. Department of Statistical Analysis, Translational Research Informatics Center, Kobe, Japan

    Takashi Kikuchi PhD, DPhil

  15. Department of Surgery Oncology, Tokyo Medical and Dental University, Tokyo, Japan

    Kenichi Sugihara MD, PhD

Authors
  1. Hiroyuki Uetake MD, PhD
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  2. Masamichi Yasuno MD, PhD
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  3. Megumi Ishiguro MD, PhD
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  4. Shingo Kameoka MD, PhD
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  5. Yasuhiro Shimada MD, PhD
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  6. Keiichi Takahashi MD, PhD
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  7. Toshiaki Watanabe MD, PhD
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  8. Kei Muro MD, PhD
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  9. Hideo Baba MD, PhD
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  10. Junji Yamamoto MD, PhD
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  11. Nobuyuki Mizunuma MD, PhD
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  12. Hiroshi Tamagawa MD, PhD
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  13. Izumi Mochizuki MD, PhD
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  14. Yusuke Kinugasa MD, PhD
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  15. Takashi Kikuchi PhD, DPhil
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  16. Kenichi Sugihara MD, PhD
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Corresponding author

Correspondence to Hiroyuki Uetake MD, PhD.

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Uetake, H., Yasuno, M., Ishiguro, M. et al. A Multicenter Phase II Trial of mFOLFOX6 Plus Bevacizumab to Treat Liver-Only Metastases of Colorectal Cancer that are Unsuitable for Upfront Resection (TRICC0808). Ann Surg Oncol 22, 908–915 (2015). https://doi.org/10.1245/s10434-014-4094-7

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  • DOI: https://doi.org/10.1245/s10434-014-4094-7

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