title: Phase II study of irinotecan plus S-1 combination for previously untreated advanced non-small cell lung cancer: Hokkaido Lung Cancer Clinical Study Group Trial (HOT) 0601.
abstract: OBJECTIVE
  Platinum-free regimens can represent an alternative for advanced non-small cell lung cancer (NSCLC) if similar efficacy is provided with better tolerability. This study evaluated the efficacy and safety of combined irinotecan and S-1 for chemotherapy-naïve advanced NSCLC.
  
  
  METHODS
  Chemotherapy consisted of 4-week cycles of intravenous irinotecan (100 mg/m(2), days 1 and 15) and oral S-1 (80 mg/m(2), days 1-14). The primary endpoint was response rate, while secondary endpoints were overall survival, progression-free survival (PFS), and safety.
  
  
  RESULTS
  A total of 112 cycles was administered to 40 patients (median 3 cycles; range 1-6 cycles). Twelve patients showed partial response and 17 patients had stable disease, representing a response rate of 30% and a disease control rate of 72.5%. Median survival time and median PFS were 16.1 and 4.8 months, respectively. Hematological toxicities of grade 3 or 4 were neutropenia (32.5%) and anemia (5.0%). The most common nonhematological toxicities of grade 3 or 4 included diarrhea (15.0%) and anorexia (17.5%). Patients homo- or heterozygous for UGTA1A*6 tended to show a higher incidence of grade 3 diarrhea (p = 0.055).
  
  
  CONCLUSIONS
  The combination of irinotecan and S-1 offers good efficacy and tolerability for previously untreated advanced NSCLC.
authors.affiliation: Department of Respiratory Medicine, Sapporo City General Hospital, Sapporo, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Akie
authors.forename: Satoshi
authors.initials: S
authors.lastname: Oizumi
authors.forename: Shigeaki
authors.initials: S
authors.lastname: Ogura
authors.forename: Naofumi
authors.initials: N
authors.lastname: Shinagawa
authors.forename: Eiki
authors.initials: E
authors.lastname: Kikuchi
authors.forename: Shinichi
authors.initials: S
authors.lastname: Fukumoto
authors.forename: Masao
authors.initials: M
authors.lastname: Harada
authors.forename: Ichiro
authors.initials: I
authors.lastname: Kinoshita
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Kojima
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Harada
authors.forename: Yuka
authors.initials: Y
authors.lastname: Fujita
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Ohsaki
authors.forename: Hirotoshi
authors.initials: H
authors.lastname: Dosaka-Akita
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Isobe
authors.forename: Masaharu
authors.initials: M
authors.lastname: Nishimura
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D004338:Drug Combinations; D005260:Female; D005838:Genotype; D014453:Glucuronosyltransferase / Q000235:genetics; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects; D000099148:UGT1A1 Enzyme
chemical_list: D002166:Camptothecin; D004338:Drug Combinations; D014453:Glucuronosyltransferase; D000077146:Irinotecan; D010094:Oxonic Acid; D005641:Tegafur; D000099148:UGT1A1 Enzyme; C079198:S 1 (combination)