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Cancer Chemotherapy and Pharmacology

, Volume 79, Issue 3, pp 519–525 | Cite as

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

  • 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
Original Article

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.

Keywords

mFOLFOX6 Rectal cancer Resectable Neoadjuvant chemotherapy Preoperative chemotherapy 

Notes

Compliance with ethical standards

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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Copyright information

© Springer-Verlag Berlin Heidelberg 2017

Authors and Affiliations

  • Junichi Koike
    • 1
    • 12
  • Kimihiko Funahashi
    • 1
    • 12
  • Kazuhiko Yoshimatsu
    • 2
    • 12
  • Hajime Yokomizo
    • 2
    • 12
  • Hayato Kan
    • 3
    • 12
  • Takeshi Yamada
    • 3
    • 12
  • Hideyuki Ishida
    • 4
    • 12
  • Keiichiro Ishibashi
    • 4
    • 12
  • Yoshihisa Saida
    • 5
    • 12
  • Toshiyuki Enomoto
    • 5
    • 12
  • Kenji Katsumata
    • 6
    • 12
  • Masayuki Hisada
    • 6
    • 12
  • Hirotoshi Hasegawa
    • 7
    • 12
  • Keiji Koda
    • 8
    • 12
  • Takumi Ochiai
    • 9
    • 12
  • Kazuhiro Sakamoto
    • 10
    • 12
  • Hiroyuki Shiokawa
    • 1
    • 12
  • Shimpei Ogawa
    • 11
    • 12
  • Michio Itabashi
    • 11
    • 12
  • Shingo Kameoka
    • 11
    • 12
  1. 1.Department of Gastroenterological Surgery, Omori Medical CenterToho University School of MedicineTokyoJapan
  2. 2.Department of SurgeryTokyo Women’s Medical University Medical Center EastTokyoJapan
  3. 3.Department of Gastrointestinal and Hepato-Biliary-Pancreatic SurgeryNippon Medical SchoolTokyoJapan
  4. 4.Department of Digestive Tract and General Surgery, Saitama Medical CenterSaitama Medical UniversitySaitamaJapan
  5. 5.Department of SurgeryToho University Ohashi Medical CenterTokyoJapan
  6. 6.Department of Digestive Surgery and Pediatric SurgeryTokyo Medical UniversityTokyoJapan
  7. 7.Department of SurgeryKeio University School of MedicineTokyoJapan
  8. 8.Department of SurgeryTeikyo University Chiba Medical CenterChibaJapan
  9. 9.Department of Surgery, Tobu Chiiki HospitalTokyo Metropolitan Health and Medical Treatment CorporationTokyoJapan
  10. 10.Department of Coloproctological Surgery, Faculty of MedicineJuntendo UniversityTokyoJapan
  11. 11.Department of Surgery, Institute of GastroenterologyTokyo Women’s Medical UniversityTokyoJapan
  12. 12.FACT Trial GroupTokyoJapan

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