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International Journal of Clinical Oncology

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01-04-2013 | Original Article

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

Authors: Takao Takahashi, Yoshihisa Shibata, Yuichiro Tojima, Kenji Tsuboi, Eiji Sakamoto, Katsuyuki Kunieda, Hiroshi Matsuoka, Kazuyoshi Suzumura, Mikinori Sato, Tatsushi Naganuma, Junichi Sakamoto, Satoshi Morita, Ken Kondo

Published in: International Journal of Clinical Oncology | Issue 2/2013

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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Title: Multicenter phase II study of modified FOLFOX6 as neoadjuvant chemotherapy for patients with unresectable liver-only metastases from colorectal cancer in Japan: ROOF study
Authors: Takao Takahashi
Yoshihisa Shibata
Yuichiro Tojima
Kenji Tsuboi
Eiji Sakamoto
Katsuyuki Kunieda
Hiroshi Matsuoka
Kazuyoshi Suzumura
Mikinori Sato
Tatsushi Naganuma
Junichi Sakamoto
Satoshi Morita
Ken Kondo
Publication date: 01-04-2013
Publisher: Springer Japan
Published in: International Journal of Clinical Oncology / Issue 2/2013
Print ISSN: 1341-9625
Electronic ISSN: 1437-7772
DOI: https://doi.org/10.1007/s10147-012-0382-z

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Abstract

Background

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