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

Emiko Takeshita¹, Keiichiro Ishibashi², Keiji Koda³, Noritaka Oda⁴, Kazuhiko Yoshimatsu⁵, Yu Sato⁶, Masatoshi Oya¹, Satoru Yamaguchi⁷, Hideo Nakajima⁸, Tomoyuki Momma⁹, Hiroshi Maekawa¹⁰, Masahiro Tsubaki¹¹, Takeshi Yamada¹², Michiya Kobayashi¹³, Kohji Tanakaya¹⁴, Hideyuki Ishida¹⁵

Affiliations

¹ Department of Surgery, Saitama Medical Center, Dokkyo University, Kosihgaya, Japan.
² Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan.
³ Department of Surgery, Teikyo University Chiba Medical Center, Ichihara, Japan.
⁴ Colo-Proctological Institute, Matsuda Hospital, Hamamatsu, Japan.
⁵ Department of Surgery, Tokyo Women's Medical University Medical Center East, Tokyo, Japan.
⁶ Department of Surgery, Toho University Sakura Medical Center, Sakura, Japan.
⁷ First Department of Surgery, Dokkyo Medical University, Mibu, Japan.
⁸ Department of Oncology, Ageo Central General Hospital, Ageo, Japan.
⁹ Department of Gastrointestinal Tract Surgery, Fukushima Medical University, Fukushima, Japan.
¹⁰ Department of Surgery, Juntendo University Shizuoka Hospital, Izunokuni, Japan.
¹¹ Department of Surgery, Yuai Memorial Hospital, Koga, Japan.
¹² Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Nippon Medical School, Tokyo, Japan.
¹³ Cancer Treatment Center, Kochi Medical School Hospital, Nankoku, Japan.
¹⁴ Department of Surgery, Iwakuni Clinical Center, Iwakuni, Japan.
¹⁵ Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan. 05hishi@saitama-med.ac.jp.

PMID: 33586034
DOI: 10.1007/s00595-021-02230-8

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

Emiko Takeshita et al. Surg Today. 2021 Aug.

. 2021 Aug;51(8):1309-1319.

doi: 10.1007/s00595-021-02230-8. Epub 2021 Feb 14.

Authors

Affiliations

¹ Department of Surgery, Saitama Medical Center, Dokkyo University, Kosihgaya, Japan.
² Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan.
³ Department of Surgery, Teikyo University Chiba Medical Center, Ichihara, Japan.
⁴ Colo-Proctological Institute, Matsuda Hospital, Hamamatsu, Japan.
⁵ Department of Surgery, Tokyo Women's Medical University Medical Center East, Tokyo, Japan.
⁶ Department of Surgery, Toho University Sakura Medical Center, Sakura, Japan.
⁷ First Department of Surgery, Dokkyo Medical University, Mibu, Japan.
⁸ Department of Oncology, Ageo Central General Hospital, Ageo, Japan.
⁹ Department of Gastrointestinal Tract Surgery, Fukushima Medical University, Fukushima, Japan.
¹⁰ Department of Surgery, Juntendo University Shizuoka Hospital, Izunokuni, Japan.
¹¹ Department of Surgery, Yuai Memorial Hospital, Koga, Japan.
¹² Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Nippon Medical School, Tokyo, Japan.
¹³ Cancer Treatment Center, Kochi Medical School Hospital, Nankoku, Japan.
¹⁴ Department of Surgery, Iwakuni Clinical Center, Iwakuni, Japan.
¹⁵ Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan. 05hishi@saitama-med.ac.jp.

PMID: 33586034
DOI: 10.1007/s00595-021-02230-8

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.

Keywords: Adjuvant chemotherapy; CAPOX; Peripheral sensory neuropathy; Stage III colon cancer; mFOLFOX6.

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References

1. André T, de GramontVernerey AD, Chibaudel B, Bonnetain F, Tijeras-Raballand A, et al. Adjuvant fluorouracil, leucovorin, and oxaliplatin in stage II to III colon cancer: updated 10-year survival and outcomes according to BRAF mutation and mismatch repair status of the MOSAIC study. J Clin Oncol. 2015;33:4176–87. - DOI
1. Kuebler JP, Wieand HS, O’Connell MJ, Smith RE, Colangelo LH, Yothers G, et al. Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: results from NSABP C-07. J Clin Oncol. 2007;25:2198–204. - DOI
1. Schmoll HJ, Tabernero J, Maroun J, de BraudPrice FT, Van Cutsem E, et al. Capecitabine plus oxaliplatin compared with fluorouracil/folinic acid as adjuvant therapy for stage III colon cancer: final results of the NO16968 randomized controlled phase III trial. J Clin Oncol. 2015;33:3733–40. - DOI
1. Ishibashi K, Kumamoto K, Koda K, Kato H, Nishimura G, Yoshimatsu K, et al. A phase II clinical study of mFOLFOX6/XELOX as adjuvant chemotherapy after curative resection of stage III colon cancer: the FACOS study. Ann Cancer Res Ther. 2016;24:17–22. - DOI
1. Yoshimatsu K, Ishibashi K, Koda K, Yokomizo H, Oda N, Oshiro M, et al. A Japanese multicenter phase II study of adjuvant chemotherapy with mFOLFOX6/CAPOX for stage III colon cancer treatment after D2/D3 lymphadenectomy. Surg Today. 2019;49:498–506. - DOI

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

Affiliations

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

Authors

Affiliations

Abstract

References

MeSH terms

Substances

Supplementary concepts

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical