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

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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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Acknowledgments

We thank all patients and their relatives for their willingness to participate in the study and the study team at the seven facilities for their cooperation with case registration. We also thank Ms. Yukari Hayashi and Ms. Sayaka Tokuda for great assistance in data management.

Author information

Authors and Affiliations

  1. Department of Surgery, Graduate School of Medicine, Kyoto University, 54 Kawahara-cho, Sho-go-in, Sakyo-ku, Kyoto, 606-8507, Japan

    Satoshi Nagayama, Suguru Hasegawa, Koya Hida, Kenji Kawada, Etsuro Hatano, Kojiro Nakamura, Satoru Seo, Kojiro Taura, Kentaro Yasuchika, Yoshiharu Sakai & Shinji Uemoto

  2. Department of Surgery, Shiga Medical Center for Adults, 5-4-30 Moriyama, Moriyama City, Shiga, Japan

    Takashi Matsuo & Masazumi Zaima

  3. Department of Surgery, Osaka Red Cross Hospital, 5-30 Fudegasaki-cho, Ten-noji-ku, Osaka, Japan

    Akiyoshi Kanazawa

  4. Department of Surgery, Kitano Hospital, 2-4-20 Oogimachi, Kita-ku, Osaka, Japan

    Hiroaki Terajima & Masaharu Tada

  5. Department of Surgery, Saiseikai Noe Hospital, 1-3-25 Furuichi, Joto-ku, Osaka, Japan

    Yukihito Adachi

  6. Department of Surgery, Kyoto Katsura Hospital, 17 Hirao-cho, Yamada, Nishikyo-ku, Kyoto, Japan

    Ryuta Nishitai & Dai Manaka

  7. Department of Surgery, Tenri Yorozu Hospital, 200 Mishima-cho, Tenri, Nara, Japan

    Tsunehiro Yoshimura

  8. Department of Surgery, Fukui Red Cross Hospital, 2-4-1 Tsukimi, Fukui, Japan

    Koji Doi

  9. Department of Medical Oncology, Kyoto University Hospital, 54 Kawahara-cho, Sho-go-in, Sakyo-ku, Kyoto, Japan

    Takahiro Horimatsu & Shigemi Matsumoto

  10. Department of Surgery, Mitsubishi Kyoto Hospital, 1 Gosho-cho, Katsura, Sakyo-ku, Kyoto, Japan

    Akira Mitsuyoshi

  11. Translational Research Center, Kyoto University Hospital, 54 Kawahara-cho, Sho-go-in, Sakyo-ku, Kyoto, Japan

    Kenichi Yoshimura & Miyuki Niimi

Authors
  1. Satoshi Nagayama
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  2. Suguru Hasegawa
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Corresponding author

Correspondence to Satoshi Nagayama.

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Nagayama, S., Hasegawa, S., Hida, K. et al. Multi-institutional phase II study on the feasibility of liver resection following preoperative mFOLFOX6 therapy for resectable liver metastases from colorectal cancers. Int J Clin Oncol 22, 316–323 (2017). https://doi.org/10.1007/s10147-016-1050-5

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  • DOI: https://doi.org/10.1007/s10147-016-1050-5

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