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

Research output: Contribution to journalArticle

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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.

Original languageEnglish
Pages (from-to)1-7
Number of pages7
JournalCancer Chemotherapy and Pharmacology
DOIs
Publication statusAccepted/In press - 2017 Feb 1

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oxaliplatin
Chemotherapy
Rectal Neoplasms
Fluorouracil
Safety
Drug Therapy
Leucovorin
Surgery
Tomography
Febrile Neutropenia
Neoadjuvant Therapy
Leukopenia
Peripheral Nervous System Diseases
Adjuvant Chemotherapy
Neutropenia
Nausea
Vomiting
Disease Progression
Therapeutics
Physicians

Keywords

  • mFOLFOX6
  • Neoadjuvant chemotherapy
  • Preoperative chemotherapy
  • Rectal cancer
  • Resectable

ASJC Scopus subject areas

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

Cite this

Efficacy and safety of neoadjuvant chemotherapy with oxaliplatin, 5-fluorouracil, and levofolinate for T3 or T4 stage II/III rectal cancer : the FACT trial. / Koike, Junichi; Funahashi, Kimihiko; Yoshimatsu, Kazuhiko; Yokomizo, Hajime; Kan, Hayato; Yamada, Takeshi; Ishida, Hideyuki; Ishibashi, Keiichiro; Saida, Yoshihisa; Enomoto, Toshiyuki; Katsumata, Kenji; Hisada, Masayuki; Hasegawa, Hirotoshi; Koda, Keiji; Ochiai, Takumi; Sakamoto, Kazuhiro; Shiokawa, Hiroyuki; Ogawa, Shimpei; Itabashi, Michio; Kameoka, Shingo.

In: Cancer Chemotherapy and Pharmacology, 01.02.2017, p. 1-7.

Research output: Contribution to journalArticle

Koike, J, Funahashi, K, Yoshimatsu, K, Yokomizo, H, Kan, H, Yamada, T, Ishida, H, Ishibashi, K, Saida, Y, Enomoto, T, Katsumata, K, Hisada, M, Hasegawa, H, Koda, K, Ochiai, T, Sakamoto, K, Shiokawa, H, Ogawa, S, Itabashi, M & Kameoka, S 2017, '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 Chemotherapy and Pharmacology, pp. 1-7. https://doi.org/10.1007/s00280-017-3243-7
Koike, Junichi ; Funahashi, Kimihiko ; Yoshimatsu, Kazuhiko ; Yokomizo, Hajime ; Kan, Hayato ; Yamada, Takeshi ; Ishida, Hideyuki ; Ishibashi, Keiichiro ; Saida, Yoshihisa ; Enomoto, Toshiyuki ; Katsumata, Kenji ; Hisada, Masayuki ; Hasegawa, Hirotoshi ; Koda, Keiji ; Ochiai, Takumi ; Sakamoto, Kazuhiro ; Shiokawa, Hiroyuki ; Ogawa, Shimpei ; Itabashi, Michio ; Kameoka, Shingo. / Efficacy and safety of neoadjuvant chemotherapy with oxaliplatin, 5-fluorouracil, and levofolinate for T3 or T4 stage II/III rectal cancer : the FACT trial. In: Cancer Chemotherapy and Pharmacology. 2017 ; pp. 1-7.
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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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T1 - Efficacy and safety of neoadjuvant chemotherapy with oxaliplatin, 5-fluorouracil, and levofolinate for T3 or T4 stage II/III rectal cancer

T2 - the FACT trial

AU - Koike, Junichi

AU - Funahashi, Kimihiko

AU - Yoshimatsu, Kazuhiko

AU - Yokomizo, Hajime

AU - Kan, Hayato

AU - Yamada, Takeshi

AU - Ishida, Hideyuki

AU - Ishibashi, Keiichiro

AU - Saida, Yoshihisa

AU - Enomoto, Toshiyuki

AU - Katsumata, Kenji

AU - Hisada, Masayuki

AU - Hasegawa, Hirotoshi

AU - Koda, Keiji

AU - Ochiai, Takumi

AU - Sakamoto, Kazuhiro

AU - Shiokawa, Hiroyuki

AU - Ogawa, Shimpei

AU - Itabashi, Michio

AU - Kameoka, Shingo

PY - 2017/2/1

Y1 - 2017/2/1

N2 - 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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KW - mFOLFOX6

KW - Neoadjuvant chemotherapy

KW - Preoperative chemotherapy

KW - Rectal cancer

KW - Resectable

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