title: Phase I/II study of S-1 combined with biweekly irinotecan chemotherapy in previously treated advanced non-small cell lung cancer.
abstract: OBJECTIVE
  This phase I/II study was designed to evaluate a combination of irinotecan and S-1 a new regimen for salvage chemotherapy in patients with advanced or metastatic non-small cell lung cancer (NSCLC).
  
  
  METHODS
  The study group comprised patients with advanced or metastatic NSCLC who had previously received at least one platinum-containing chemotherapy. Patients received irinotecan on days 1, 15 and oral S-1 (40 mg/m(2) twice daily as a fixed dose) on day 1 to 14 of a 28-day cycle.
  
  
  RESULTS
  In the phase I part, irinotecan was given in escalating doses of 70 (Level 1), 80 (Level 2), and 90 mg/m(2) (Level 3). Three of the 5 patients given Level 3 had dose-limiting toxicity, and Level 2 (80 mg/m(2) of irinotecan) was designated as the recommended dose. In phase II, 38 patients received a median of 7.4 cycles of irinotecan at the recommended dose. The overall response rate was 15.8 % (90 % confidence interval (CI): 6.1-25.5 %), and the median progression-free and overall survival times were 4.5 months (95 % CI: 3.5-5.0) and 15.0 months (95 % CI: 9.5-20.6) months, respectively. Toxicity was generally mild. Grade 3 or higher toxicity included neutropenia in 17.9 % of the patients, thrombocytopenia in 5.1 % and nausea in 7.7 %.
  
  
  CONCLUSIONS
  Combination chemotherapy with S-1 and irinotecan was considered an effective salvage regimen in patients with advanced or metastatic NSCLC.
authors.affiliation: Respiratory Division, Nagano Red Cross Hospital, Nagano, Japan.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Goya
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kuraishi
authors.forename: Shigeru
authors.initials: S
authors.lastname: Koyama
authors.forename: Takashi
authors.initials: T
authors.lastname: Ichiyama
authors.forename: Fumiaki
authors.initials: F
authors.lastname: Yoshiike
authors.forename: Kazuya
authors.initials: K
authors.lastname: Hirai
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Agatsuma
authors.forename: Kazunari
authors.initials: K
authors.lastname: Tateishi
authors.forename: Shintaro
authors.initials: S
authors.lastname: Kanda
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Yamamoto
authors.forename: Keishi
authors.initials: K
authors.lastname: Kubo
authors.forename: Tomonobu
authors.initials: T
authors.lastname: Koizumi
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage; D016879:Salvage Therapy / Q000379:methods; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000077146:Irinotecan; D002166:Camptothecin