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International Journal of Clinical Oncology

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01-04-2017 | Original Article

Multi-institutional phase II study on the feasibility of liver resection following preoperative mFOLFOX6 therapy for resectable liver metastases from colorectal cancers

Authors: Satoshi Nagayama, Suguru Hasegawa, Koya Hida, Kenji Kawada, Etsuro Hatano, Kojiro Nakamura, Satoru Seo, Kojiro Taura, Kentaro Yasuchika, Takashi Matsuo, Masazumi Zaima, Akiyoshi Kanazawa, Hiroaki Terajima, Masaharu Tada, Yukihito Adachi, Ryuta Nishitai, Dai Manaka, Tsunehiro Yoshimura, Koji Doi, Takahiro Horimatsu, Akira Mitsuyoshi, Kenichi Yoshimura, Miyuki Niimi, Shigemi Matsumoto, Yoshiharu Sakai, Shinji Uemoto

Published in: International Journal of Clinical Oncology | Issue 2/2017

Abstract

Background

Although liver resection combined with preoperative chemotherapy is expected to improve outcomes of patients with resectable colorectal liver metastasis (CRLM), there is as yet insufficient clinical evidence supporting the efficacy of preoperative systemic chemotherapy. The aim of this phase II study was to assess the feasibility and efficacy of preoperative FOLFOX systemic chemotherapy for patients with initially resectable CRLM.

Methods

A prospective multi-institutional phase II study was conducted to evaluate the feasibility and efficacy of preoperative chemotherapy for resectable CRLM (ClinicalTrials.gov identifier number NCT00594529). Patients were scheduled to receive 6 cycles of mFOLFOX6 therapy before liver surgery. The primary endpoint was the macroscopic curative resection rate.

Results

A total of 30 patients were included in this study. Two patients who were diagnosed with hepatocellular and intrahepatic cholangiocellular carcinoma based on pathology were excluded from the analysis. More than half of the patients (57 %) had solitary liver metastasis. The completion rate of preoperative chemotherapy was 64.3 % and the response rate was 53.6 %. Two patients were unable to proceed to liver resections due to disease progression and severe postoperative complications following primary tumor resection. Macroscopic curative resection was obtained in 89.3 % of eligible patients. Postoperative mortality and severe complication (≥Gr. 3) rates were 0 and 11 %, respectively. The 3-year overall and progression-free survival rates were 81.9 and 47.4 %, respectively.

Conclusion

Our phase II study demonstrated the feasibility of liver resection combined with preoperative mFOLFOX6 therapy in patients with initially resectable CRLM. Further study is warranted to address the oncological effects of preoperative chemotherapy.

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Title: Multi-institutional phase II study on the feasibility of liver resection following preoperative mFOLFOX6 therapy for resectable liver metastases from colorectal cancers
Authors: Satoshi Nagayama
Suguru Hasegawa
Koya Hida
Kenji Kawada
Etsuro Hatano
Kojiro Nakamura
Satoru Seo
Kojiro Taura
Kentaro Yasuchika
Takashi Matsuo
Masazumi Zaima
Akiyoshi Kanazawa
Hiroaki Terajima
Masaharu Tada
Yukihito Adachi
Ryuta Nishitai
Dai Manaka
Tsunehiro Yoshimura
Koji Doi
Takahiro Horimatsu
Akira Mitsuyoshi
Kenichi Yoshimura
Miyuki Niimi
Shigemi Matsumoto
Yoshiharu Sakai
Shinji Uemoto
Publication date: 01-04-2017
Publisher: Springer Japan
Published in: International Journal of Clinical Oncology / Issue 2/2017
Print ISSN: 1341-9625
Electronic ISSN: 1437-7772
DOI: https://doi.org/10.1007/s10147-016-1050-5

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