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The updated five-year overall survival and long-term oxaliplatin-related neurotoxicity assessment of the FACOS study

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Abstract

Purpose

We previously reported the first evidence of oncological benefits from a Japanese phase II trial of oxaliplatin-based adjuvant chemotherapy in patients with stage III colon cancer (the FACOS study). We herein report the long-term survival and persistent oxaliplatin-related peripheral sensory neuropathy (PSN) for patients enrolled in this trial.

Methods

Patients were scheduled to receive the mFOLFOX6 or CAPOX regimen in the adjuvant setting. The five-year overall survival (OS) rate and persistent PSN were evaluated.

Results

A total of 130 patients (mFOLFOX6, n = 73; CAPOX, n = 57) were eligible. The 5-year OS rate was 91.4%. No significant difference in the OS rate was observed between regimens (mFOLFOX6, 94.4%; CAPOX, 87.4%; P = 0.25). The incidence of PSN during adjuvant treatment was 55.4% in grade 1 (G1), 30.0% in G2, and 4.6% in G3. No patients showed G3 PSN at 12 months, but G1 or G2 residual PSN after 5 years was observed in 21.8% (G1, 20%; G2, 1.8%).

Conclusions

Updated results from the FACOS study support the benefits of oxaliplatin-based adjuvant chemotherapy in terms of the long-term survival among Japanese patients with stage III colon cancer. However, long-term persistent PSN occurs in about 20% of survivors, counterbalancing the favorable OS.

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Authors and Affiliations

  1. Department of Surgery, Saitama Medical Center, Dokkyo University, Kosihgaya, Japan

    Emiko Takeshita & Masatoshi Oya

  2. Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan

    Keiichiro Ishibashi & Hideyuki Ishida

  3. Department of Surgery, Teikyo University Chiba Medical Center, Ichihara, Japan

    Keiji Koda

  4. Colo-Proctological Institute, Matsuda Hospital, Hamamatsu, Japan

    Noritaka Oda

  5. Department of Surgery, Tokyo Women’s Medical University Medical Center East, Tokyo, Japan

    Kazuhiko Yoshimatsu

  6. Department of Surgery, Toho University Sakura Medical Center, Sakura, Japan

    Yu Sato

  7. First Department of Surgery, Dokkyo Medical University, Mibu, Japan

    Satoru Yamaguchi

  8. Department of Oncology, Ageo Central General Hospital, Ageo, Japan

    Hideo Nakajima

  9. Department of Gastrointestinal Tract Surgery, Fukushima Medical University, Fukushima, Japan

    Tomoyuki Momma

  10. Department of Surgery, Juntendo University Shizuoka Hospital, Izunokuni, Japan

    Hiroshi Maekawa

  11. Department of Surgery, Yuai Memorial Hospital, Koga, Japan

    Masahiro Tsubaki

  12. Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Nippon Medical School, Tokyo, Japan

    Takeshi Yamada

  13. Cancer Treatment Center, Kochi Medical School Hospital, Nankoku, Japan

    Michiya Kobayashi

  14. Department of Surgery, Iwakuni Clinical Center, Iwakuni, Japan

    Kohji Tanakaya

Authors
  1. Emiko Takeshita
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Correspondence to Hideyuki Ishida.

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Conflict of interest

Keiichiro Ishibashi, Michiya Kobayashi, and Hideyuki Ishida received a research grant from Yakult Co., Ltd., and Chugai Pharmaceutical Co., Ltd. Emiko Takeshita and Masatoshi Oya received a research grant from Yakult Co., Ltd., and Hiroshi Maekawa received a research grant from Chugai Pharmaceutical Co., Ltd. The other authors have no conflicts of interest to declare.

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Takeshita, E., Ishibashi, K., Koda, K. et al. The updated five-year overall survival and long-term oxaliplatin-related neurotoxicity assessment of the FACOS study. Surg Today 51, 1309–1319 (2021). https://doi.org/10.1007/s00595-021-02230-8

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