title: Phase II study of irinotecan as a third- or fourth-line treatment for advanced non-small cell lung cancer: NJLCG0703.
abstract: BACKGROUND
  We aimed to evaluate the efficacy and safety of irinotecan monotherapy as a third- or fourth-line treatment for advanced non-small cell lung cancer (NSCLC) patients.
  
  
  METHODS
  Patients with advanced NSCLC refractory to 2 or more previous regimens were treated with 80 mg/m2 irinotecan on days 1, 8, and 15, every 4 weeks. The primary endpoint was the overall response rate (ORR), whereas secondary endpoints included progression-free survival (PFS), overall survival (OS), and toxicity profiles.
  
  
  RESULTS
  From December 2007 to April 2009, 32 patients (median age, 60 years) were enrolled. Most of the patients (75.0%) were male, and 18.8% had a performance status of 2. Six partial responses to irinotecan monotherapy were observed (ORR, 18.8%: 95% confidence interval, 5.3%-32.3%). The disease control rate (DCR) was 78.1%, median PFS was 4.0 months, and median survival time (MST) was 10.4 months. Grade 3-4 neutropenia was observed in 22% of patients, but other toxic effects were moderate. No cases of grade 3-4 diarrhea or treatment-related death were noted. Of the 15 patients for whom progressive disease represented the best response to previous treatment regimens, 2 exhibited a partial response and 9 showed stable disease after irinotecan monotherapy, with a DCR of 73.3%, median PFS of 4.4 months, and MST of 8.2 months.
  
  
  CONCLUSIONS
  Irinotecan monotherapy is effective for advanced NSCLC patients who have previously failed 2 or more treatment regimens.
authors.affiliation: Department of Respiratory Medicine, Miyagi Cancer Center, 47-1 Nodayama, Medeshima-shiote, Natori, 981-1293, Japan.
authors.forename: Nobumichi
authors.initials: N
authors.lastname: Matsubara
authors.forename: Makoto
authors.initials: M
authors.lastname: Maemondo
authors.forename: Akira
authors.initials: A
authors.lastname: Inoue
authors.forename: Osamu
authors.initials: O
authors.lastname: Ishimoto
authors.forename: Kana
authors.initials: K
authors.lastname: Watanabe
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Sakakibara
authors.forename: Tatsuro
authors.initials: T
authors.lastname: Fukuhara
authors.forename: Naoto
authors.initials: N
authors.lastname: Morikawa
authors.forename: Masashi
authors.initials: M
authors.lastname: Tanaka
authors.forename: Shunichi
authors.initials: S
authors.lastname: Sugawara
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Nukiwa
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D018450:Disease Progression; D004334:Drug Administration Schedule; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000453:epidemiology; D016879:Salvage Therapy; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D000077146:Irinotecan; D002166:Camptothecin