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Multicenter phase II study of modified FOLFOX6 as neoadjuvant chemotherapy for patients with unresectable liver-only metastases from colorectal cancer in Japan: ROOF study

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Abstract

Background

Neoadjuvant chemotherapy for unresectable colorectal liver metastases can reduce tumor size, which sometimes leads to curative resection. The aim of the present study was to identify and describe patients with initially unresectable liver-only metastases from colorectal cancer who obtained sufficient chemotherapeutic benefit that eventually lead to the removal of the metastatic diseases in the liver.

Methods

A phase II multicenter cooperative study was conducted in 38 medical institutions using modified FOLFOX6 (mFOLFOX6) as neoadjuvant chemotherapy from January 2008 to June 2009. Patients with liver-only metastases from colorectal cancer that was deemed not optimally resectable by liver surgeons received mFOLFOX6 as preoperative neoadjuvant chemotherapy for 6-8 cycles. Patients were reassessed for resectability after 6 cycles of mFOLFOX6. Surgery was carried out 3-6 weeks after chemotherapy. The primary endpoint was the rate of macroscopic curative surgery including liver resection.

Results

36 patients (23 male/13 female, ECOG performance status 0-1) were enrolled. The median age of the patients was 62.5 years; 78% (28 patients) had 5 or more metastatic tumors, and 50% (18 patients) had metastatic tumors over 5 cm diameter. The mFOLFOX6 regimen was safety administered resulting in 18 partial responses (50%), 12 stable disease, and 4 progressive disease. There was no grade 3/4 neurotoxicity. Fourteen patients (38.9%) underwent surgery (R0: 13; R1: 1). Of these, thirteen patients (36.1%) underwent R0 surgery.

Conclusions

Our data suggest that mFOLFOX6 has a high response rate in patients with liver-only metastases from colorectal cancer, allowing for R0 resection of liver metastases in a proportion of patients initially not judged to be optimally resectable.

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Acknowledgments

We thank Mai Hatta for her great help. This work was supported, in part, by a Non Profit Organization Epidemiological & Clinical Research Information Network (ECRIN).

Conflict of interest

No author has any conflict of interest.

Author information

Authors and Affiliations

  1. Department of Surgical Oncology, Gifu University School of Medicine, 1-1 Yanagido, Gifu, 501-1194, Japan

    Takao Takahashi

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

    Yoshihisa Shibata

  3. Department of Surgery, Chukyo Hospital, Nagoya, Japan

    Yuichiro Tojima

  4. Department of Surgery, Tosei General Hospital, Seto, Japan

    Kenji Tsuboi

  5. Department of Surgery, Nagoya Daini Red Cross Hospital, Nagoya, Japan

    Eiji Sakamoto

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

    Katsuyuki Kunieda

  7. Department of Surgery, Fujita Health University, Toyoake, Japan

    Hiroshi Matsuoka

  8. Department of Surgery, Aichi Medical University, Nagakute, Japan

    Kazuyoshi Suzumura

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

    Mikinori Sato

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

    Tatsushi Naganuma

  11. Young Leaders’ Program in Healthcare Administration, Department of Social Life Science, Nagoya University, Graduate School of Medicine, Nagoya, Japan

    Junichi Sakamoto

  12. Department of Biostatistics and Epidemiology, Yokohama City University School of Medicine and University Medical Center, Yokohama, Japan

    Satoshi Morita

  13. Department of Surgery, Nagoya Medical Center, Nagoya, Japan

    Ken Kondo

Authors
  1. Takao Takahashi
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  2. Yoshihisa Shibata
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  3. Yuichiro Tojima
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  4. Kenji Tsuboi
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  5. Eiji Sakamoto
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  6. Katsuyuki Kunieda
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  7. Hiroshi Matsuoka
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  8. Kazuyoshi Suzumura
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  9. Mikinori Sato
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  10. Tatsushi Naganuma
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  11. Junichi Sakamoto
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  12. Satoshi Morita
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  13. Ken Kondo
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Corresponding author

Correspondence to Takao Takahashi.

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Cite this article

Takahashi, T., Shibata, Y., Tojima, Y. et al. Multicenter phase II study of modified FOLFOX6 as neoadjuvant chemotherapy for patients with unresectable liver-only metastases from colorectal cancer in Japan: ROOF study. Int J Clin Oncol 18, 335–342 (2013). https://doi.org/10.1007/s10147-012-0382-z

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  • DOI: https://doi.org/10.1007/s10147-012-0382-z

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