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International Journal of Clinical Oncology

, Volume 18, Issue 2, pp 335–342 | Cite as

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

  • Takao TakahashiEmail author
  • Yoshihisa Shibata
  • Yuichiro Tojima
  • Kenji Tsuboi
  • Eiji Sakamoto
  • Katsuyuki Kunieda
  • Hiroshi Matsuoka
  • Kazuyoshi Suzumura
  • Mikinori Sato
  • Tatsushi Naganuma
  • Junichi Sakamoto
  • Satoshi Morita
  • Ken Kondo
Original Article

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.

Keywords

ROOF study mFOLFOX6 Colorectal cancer Unresectable liver-only metastases Liver resection 

Notes

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.

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Copyright information

© Japan Society of Clinical Oncology 2012

Authors and Affiliations

  • Takao Takahashi
    • 1
    Email author
  • Yoshihisa Shibata
    • 2
  • Yuichiro Tojima
    • 3
  • Kenji Tsuboi
    • 4
  • Eiji Sakamoto
    • 5
  • Katsuyuki Kunieda
    • 6
  • Hiroshi Matsuoka
    • 7
  • Kazuyoshi Suzumura
    • 8
  • Mikinori Sato
    • 9
  • Tatsushi Naganuma
    • 10
  • Junichi Sakamoto
    • 11
  • Satoshi Morita
    • 12
  • Ken Kondo
    • 13
  1. 1.Department of Surgical OncologyGifu University School of MedicineGifuJapan
  2. 2.Department of SurgeryToyohashi Municipal HospitalToyohashiJapan
  3. 3.Department of SurgeryChukyo HospitalNagoyaJapan
  4. 4.Department of SurgeryTosei General HospitalSetoJapan
  5. 5.Department of SurgeryNagoya Daini Red Cross HospitalNagoyaJapan
  6. 6.Department of SurgeryGifu Prefectural General Medical CenterGifuJapan
  7. 7.Department of SurgeryFujita Health UniversityToyoakeJapan
  8. 8.Department of SurgeryAichi Medical UniversityNagakuteJapan
  9. 9.Department of Gastroenterological SurgeryNagoya City University Graduate School of Medical SciencesNagoyaJapan
  10. 10.Department of SurgerySaiseikai Matsusaka General HospitalMatsusakaJapan
  11. 11.Young Leaders’ Program in Healthcare Administration, Department of Social Life ScienceNagoya University, Graduate School of MedicineNagoyaJapan
  12. 12.Department of Biostatistics and EpidemiologyYokohama City University School of Medicine and University Medical CenterYokohamaJapan
  13. 13.Department of SurgeryNagoya Medical CenterNagoyaJapan

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