title: Combination chemotherapy with irinotecan and cisplatin for large-cell neuroendocrine carcinoma of the lung: a multicenter phase II study.
abstract: BACKGROUND
  We conducted a phase II study of combination chemotherapy with irinotecan (CPT) and cisplatin (CDDP) in patients with advanced large-cell neuroendocrine carcinoma (LCNEC) of the lung.
  
  
  METHODS
  Patients received irinotecan (60 mg/m², days 1, 8, and 15) and cisplatin (60 mg/m², day 1) every 4 weeks for up to four cycles. The primary endpoint was the response rate. Expected and threshold values for the primary endpoint were 50% and 30%.
  
  
  RESULTS
  Forty-four patients were enrolled between January 2005 and November 2011. The response rate (RR) was 54.5% (95% confidence interval [CI], 38.8-69.6%). The median progression-free survival time was 5.9 months (95% CI, 5.5-6.3), and the median survival time was 15.1 months (95% CI, 11.2-19.0). A central pathological review of specimens from 41 patients demonstrated that 30 patients had LCNEC but that 10 patients had small-cell lung cancer (SCLC) and one had non-small-cell lung cancer with a neuroendocrine structure. The RR was 46.7% (95% CI, 28.3-65.7%) in the LCNEC group and 80% (95% CI, 44.4-97.5%) in the SCLC group (p = 0.0823). The median survival time was 12.6 months (95% CI, 9.3-16.0) in the LCNEC group and 17.3 months (95% CI, 11.2-23.3) in the SCLC group (p = 0.047).
  
  
  CONCLUSIONS
  Combination chemotherapy with irinotecan and cisplatin was active in patients with LCNEC, but the RR and the overall survival period among the patients with LCNEC seemed to be inferior to those among the patients with SCLC. Small numbers of patients were a major limitation in this study.
authors.affiliation: Division of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan. siniho@east.ncc.go.jp
authors.forename: Seiji
authors.initials: S
authors.lastname: Niho
authors.forename: Hirotsugu
authors.initials: H
authors.lastname: Kenmotsu
authors.forename: Ikuo
authors.initials: I
authors.lastname: Sekine
authors.forename: Genichiro
authors.initials: G
authors.lastname: Ishii
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Ishikawa
authors.forename: Masayuki
authors.initials: M
authors.lastname: Noguchi
authors.forename: Fumihiro
authors.initials: F
authors.lastname: Oshita
authors.forename: Shun-ichi
authors.initials: S
authors.lastname: Watanabe
authors.forename: Ryu
authors.initials: R
authors.lastname: Nakajima
authors.forename: Hirohito
authors.initials: H
authors.lastname: Tada
authors.forename: Kanji
authors.initials: K
authors.lastname: Nagai
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D018287:Carcinoma, Large Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018278:Carcinoma, Neuroendocrine / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D009367:Neoplasm Staging; D011379:Prognosis; D011446:Prospective Studies; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D015996:Survival Rate; D055815:Young Adult
chemical_list: D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin