title: Phase II trial of an alternating regimen consisting of first-line mFOLFOX6 plus bevacizumab and FOLFIRI plus bevacizumab for patients with metastatic colorectal cancer: FIREFOX plus bevacizumab trial (KSCC0801).
abstract: OBJECTIVE
  The purpose of this phase II study was to explore the efficacy and safety of an alternating regimen consisting of folinic acid, 5-fluorouracil (5-FU) and oxaliplatin (mFOLFOX6) plus bevacizumab, and folinic acid, 5-FU and irinotecan (FOLFIRI) plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer.
  
  
  METHODS
  Fifty-two patients with metastatic colorectal cancer received an alternating regimen consisting of four cycles of mFOLFOX6 plus bevacizumab followed by four cycles of FOLFIRI plus bevacizumab until disease progression. The primary endpoint was progression-free survival.
  
  
  RESULTS
  The median age was 60 years (range 37-75 years). Median progression-free survival was 14.2 months (95 % confidence interval [CI] 10.6-16.3) and median overall survival was 28.4 months (95 % CI 22.6-39.1). The overall response rate was 60.0 % (95 % CI 45.2-73.6). Regarding toxicity, the commonest grade 3-4 hematological adverse events were neutropenia (34.6 %) and leukopenia (7.7 %), and the commonest grade 3-4 non-hematological adverse events were anorexia (13.5 %), fatigue (9.6 %), nausea (9.6 %), and vomiting (9.6 %). Bevacizumab-related grade 3-4 adverse events included hypertension (1.9 %) and thrombosis (1.9 %).
  
  
  CONCLUSIONS
  An alternating regimen consisting of mFOLFOX6 plus bevacizumab and FOLFIRI plus bevacizumab is an effective and well-tolerated first-line chemotherapy combination for patients with metastatic colorectal cancer.
authors.affiliation: Multidisciplinary Treatment Cancer Center, Kurume University Hospital, 67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan. miwakeisuke@gmail.com.
authors.forename: Keisuke
authors.initials: K
authors.lastname: Miwa
authors.affiliation: Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Eiji
authors.initials: E
authors.lastname: Oki
authors.affiliation: Department of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.
authors.forename: Yasunori
authors.initials: Y
authors.lastname: Emi
authors.affiliation: Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Saeki
authors.affiliation: Department of Gastroenterological Surgery/Clinical Research Institute Cancer Research Division, National Kyushu Medical Center, Fukuoka, Japan.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Kusumoto
authors.affiliation: Department of Surgery, Kurume University School of Medicine, Kurume, Japan.
authors.forename: Yoshito
authors.initials: Y
authors.lastname: Akagi
authors.affiliation: Department of Surgery, Kurume University Medical Center, Kurume, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Ogata
authors.affiliation: Department of Surgery I, Ryukyu University, Okinawa, Japan.
authors.forename: Hironori
authors.initials: H
authors.lastname: Samura
authors.affiliation: Medical Information Center, Kyushu University Hospital, Fukuoka, Japan.
authors.forename: Shoji
authors.initials: S
authors.lastname: Tokunaga
authors.affiliation: Department of Surgery, Sasebo City General Hospital, Sasebo, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ishikawa
authors.affiliation: Department of Surgery, Social Insurance Tagawa Hospital, Tagawa, Japan.
authors.forename: Takaho
authors.initials: T
authors.lastname: Tanaka
authors.affiliation: Department of Surgery, Omuta City Hospital, Omuta, Japan.
authors.forename: Susumu
authors.initials: S
authors.lastname: Sueyoshi
authors.affiliation: Department of Surgery, Steel Memorial Yawata Hospital, Kitakyushu, Japan.
authors.forename: Hidefumi
authors.initials: H
authors.lastname: Higashi
authors.affiliation: Department of Surgery, Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital, Hiroshima, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Matsuda
authors.affiliation: Department of Surgery, Nakagami Hospital, Okinawa, Japan.
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Touyama
authors.affiliation: Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Maehara
mesh_terms: D000328:Adult; D000368:Aged; D000855:Anorexia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D000068258:Bevacizumab / Q000008:administration & dosage / Q000009:adverse effects; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D006973:Hypertension / Q000139:chemically induced; D002955:Leucovorin / Q000008:administration & dosage; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009503:Neutropenia / Q000139:chemically induced; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D015996:Survival Rate; D013927:Thrombosis / Q000139:chemically induced; D014839:Vomiting / Q000139:chemically induced
chemical_list: D009944:Organoplatinum Compounds; D000068258:Bevacizumab; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin
keywords: Chemotherapy; Colorectal cancer; FIREFOX; FOLFIRI; FOLFOX6; Neurotoxicity