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Efficacy and safety of neoadjuvant chemotherapy with oxaliplatin, 5-fluorouracil, and levofolinate for T3 or T4 stage II/III rectal cancer: the FACT trial

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Abstract

Purpose

A multicenter phase II clinical study was performed in patients with T3 or T4 stage II/III rectal cancer to evaluate the efficacy and safety of neoadjuvant chemotherapy with 5-fluorouracil, levofolinate, and oxaliplatin (mFOLFOX6).

Methods

Patients received four 2-week cycles of mFOLFOX6 therapy (oxaliplatin at 85 mg/m2 + leucovorin at 200 mg/m2 + fluorouracil as a 400 mg/m2 bolus followed by infusion of 2400 mg/m2 over 46 h, all on Day 1). They were evaluated by computed tomography after completion of the fourth cycle. If there was no disease progression, two additional cycles were administered and then surgery was performed. Adjuvant chemotherapy was generally administered for 6 months using appropriate regimens at the discretion of the physician.

Results

mFOLFOX6 therapy was given to 52 patients with locally advanced rectal cancer. The preoperative response rate was 48.8% and the operation rate was 80.8%. Serious adverse events of Grade 3–4 were neutropenia (n = 5), leukopenia (n = 1), thrombocytopenia (n = 1), febrile neutropenia (n = 1), nausea (n = 1), vomiting (n = 1), and peripheral neuropathy (n = 2). The R0 resection rate, pathologic complete response rate, and sphincter preservation rate were 91.0, 11.9, and 73.8%, respectively. Postoperative complications were tolerable.

Conclusions

The present results suggested that neoadjuvant therapy with mFOLFOX6 is safe and effective, representing a reasonable treatment option for locally advanced rectal cancer.

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Authors and Affiliations

  1. Department of Gastroenterological Surgery, Omori Medical Center, Toho University School of Medicine, 6-11-1 Omori-nishi, Ota-ku, Tokyo, 143-8541, Japan

    Junichi Koike, Kimihiko Funahashi & Hiroyuki Shiokawa

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

    Kazuhiko Yoshimatsu & Hajime Yokomizo

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

    Hayato Kan & Takeshi Yamada

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

    Hideyuki Ishida & Keiichiro Ishibashi

  5. Department of Surgery, Toho University Ohashi Medical Center, Tokyo, Japan

    Yoshihisa Saida & Toshiyuki Enomoto

  6. Department of Digestive Surgery and Pediatric Surgery, Tokyo Medical University, Tokyo, Japan

    Kenji Katsumata & Masayuki Hisada

  7. Department of Surgery, Keio University School of Medicine, Tokyo, Japan

    Hirotoshi Hasegawa

  8. Department of Surgery, Teikyo University Chiba Medical Center, Chiba, Japan

    Keiji Koda

  9. Department of Surgery, Tobu Chiiki Hospital, Tokyo Metropolitan Health and Medical Treatment Corporation, Tokyo, Japan

    Takumi Ochiai

  10. Department of Coloproctological Surgery, Faculty of Medicine, Juntendo University, Tokyo, Japan

    Kazuhiro Sakamoto

  11. Department of Surgery, Institute of Gastroenterology, Tokyo Women’s Medical University, Tokyo, Japan

    Shimpei Ogawa, Michio Itabashi & Shingo Kameoka

  12. FACT Trial Group, Tokyo, Japan

    Junichi Koike, Kimihiko Funahashi, Kazuhiko Yoshimatsu, Hajime Yokomizo, Hayato Kan, Takeshi Yamada, Hideyuki Ishida, Keiichiro Ishibashi, Yoshihisa Saida, Toshiyuki Enomoto, Kenji Katsumata, Masayuki Hisada, Hirotoshi Hasegawa, Keiji Koda, Takumi Ochiai, Kazuhiro Sakamoto, Hiroyuki Shiokawa, Shimpei Ogawa, Michio Itabashi & Shingo Kameoka

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  1. Junichi Koike
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  2. Kimihiko Funahashi
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  3. Kazuhiko Yoshimatsu
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Corresponding author

Correspondence to Junichi Koike.

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Conflict of interest

The authors had no commercial interest in the study subject. No financial or material support was received in conjunction with this work.

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Koike, J., Funahashi, K., Yoshimatsu, K. et al. Efficacy and safety of neoadjuvant chemotherapy with oxaliplatin, 5-fluorouracil, and levofolinate for T3 or T4 stage II/III rectal cancer: the FACT trial. Cancer Chemother Pharmacol 79, 519–525 (2017). https://doi.org/10.1007/s00280-017-3243-7

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  • DOI: https://doi.org/10.1007/s00280-017-3243-7

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