title: Multicenter phase II study of second-line cetuximab plus folinic acid/5-fluorouracil/irinotecan (FOLFIRI) in KRAS wild-type metastatic colorectal cancer: the FLIER study.
abstract: BACKGROUND
  This study was the first multicenter phase II study of cetuximab plus folinic acid/5-fluorouracil/irinotecan (FOLFIRI) in KRAS wild-type mCRC as a second-line treatment in Japan including BRAF and PIK3CA genotyping.
  
  
  METHODS
  Tumors of 112 pre-registered patients were genotyped for KRAS, BRAF, and PIK3CA. The primary study end-point was response rate, and secondary end-points were progression-free survival (PFS), overall survival (OS), and safety.
  
  
  RESULTS
  Sixty-seven patients (59.8%) were EGFR-positive and KRAS wild-type. The mean age of the enrolled patients (n=60) was 62.6 years (range=37-82 years). The response rate was 31.7% and stable disease was observed in 53.3%. No objective response was observed in patients with BRAF or PIK3CA mutations. The median PFS and OS were 7.4 and 18.2 months, respectively. Grade-3/4 adverse events were leucopenia (26.7%), neutropenia (43.3%), paronychia (10.0%), fissure (10.0%) and acne-like rash (5.0%).
  
  
  CONCLUSIONS
  Second-line cetuximab plus FOLFIRI was effective and well-tolerated.
authors.affiliation: Department of Surgery, Kansai Medical University Takii Hospital, 10-15 Fumizono-cho, Moriguchi-city, Osaka 570-8507, Japan. iwamoto@hirakata.kmu.ac.jp.
authors.forename: Shigeyoshi
authors.initials: S
authors.lastname: Iwamoto
authors.forename: Shoichi
authors.initials: S
authors.lastname: Hazama
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kato
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Miyake
authors.forename: Mutsumi
authors.initials: M
authors.lastname: Fukunaga
authors.forename: Chu
authors.initials: C
authors.lastname: Matsuda
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Bando
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
authors.forename: Koji
authors.initials: K
authors.lastname: Oba
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Mishima
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D000068818:Cetuximab; D017024:Chemotherapy, Adjuvant; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000473:pathology*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D011905:Genes, ras; D005838:Genotype; D006801:Humans; D000077146:Irinotecan; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016896:Treatment Outcome; D047368:Tumor Burden
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000077146:Irinotecan; D000068818:Cetuximab; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin
keywords: Colorectal cancer; FOLFIRI; Japanese; KRAS; cetuximab