title: Phase II study of cetuximab with irinotecan for KRAS wild-type colorectal cancer in Japanese patients.
abstract: OBJECTIVE
  Cetuximab improves the prognosis for wild-type KRAS metastatic colorectal cancer (MCRC). We evaluated the safety and efficacy of cetuximab in combination with irinotecan in Japanese patients with wild-type KRAS MCRC refractory to irinotecan, oxaliplatin and fluoropyrimidines.
  
  
  METHODS
  Cetuximab was administered initially at a dose of 400 mg/m2, followed by weekly infusions at 250 mg/m2. Irinotecan was administered every 2 weeks at 150 mg/m2. Primary endpoint was the incidence of grade 3/4 adverse events; secondary endpoints included overall survival (OS), progression-free survival (PFS), response rate (RR), time to treatment failure (TTF), and TTF for irinotecan.
  
  
  RESULTS
  Thirty-four patients were enrolled. Grade 3 or 4 toxicities were leucopenia (11.8%), neutropenia (23.5%), anemia (11.8%), fatigue (2.9%), anorexia (2.9%), diarrhea (14.7%) and hypomagnesemia (5.9%). Skin toxicities were as follows (any grade/grade 3): acne (94.2/8.8%), rash (55.9/0%), nail changes (75.5/8.8%) and hand-foot syndrome (55.9/5.9%). Median PFS was 6.0 months (95%CI; 4.7-7.4). Median OS was 12.9 months (95%CI; 10.0-15.9). RR was 26.4%. Median TTF was 5.1 months and median TTF for irinotecan was 5.0 months (95%CI; 4.3-5.6).
  
  
  CONCLUSIONS
  Cetuximab with irinotecan therapy was well tolerated in Japanese patients with wild-type KRAS colorectal cancer refractory to irinotecan, oxaliplatin and fluoropyrimidine, thus demonstrating the feasibility of their usage.
authors.affiliation: Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.|Cancer Chemotherapy Center, Osaka Medical College, Osaka, Japan.
authors.forename: Tetsuji
authors.initials: T
authors.lastname: Terazawa
authors.affiliation: Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.|Cancer Chemotherapy Center, Osaka Medical College, Osaka, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Nishitani
authors.affiliation: Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Kato
authors.affiliation: Department of Pharmacy, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Hironobu
authors.initials: H
authors.lastname: Hashimoto
authors.affiliation: Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.|Oncology Division, Osaka City General Hospital, Osaka, Japan.
authors.forename: Kohei
authors.initials: K
authors.lastname: Akiyoshi
authors.affiliation: Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Yuriko
authors.initials: Y
authors.lastname: Ito
authors.affiliation: Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Nakamoto
authors.affiliation: Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Satoru
authors.initials: S
authors.lastname: Iwasa
authors.affiliation: Department of Clinical Oncology, St. Marianna University School of Medicine, Kanagawa, Japan.
authors.forename: Takako Eguchi
authors.initials: TE
authors.lastname: Nakajima
authors.affiliation: Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Hamaguchi
authors.affiliation: Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Yasuhide
authors.initials: Y
authors.lastname: Yamada
authors.affiliation: Medical Oncology Division, Kochi Health Sciences Center, Kochi, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Shimada
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D044466:Asian People; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D000068818:Cetuximab / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D015996:Survival Rate; D016896:Treatment Outcome; D018631:ras Proteins / Q000187:drug effects*
chemical_list: D000077146:Irinotecan; D018631:ras Proteins; D000068818:Cetuximab; D002166:Camptothecin
keywords: Japanese patient; cetuximab; efficacy; feasibility