title: Phase II trial of gemcitabine and irinotecan in previously treated patients with small-cell lung cancer.
abstract: OBJECTIVE
  To investigate the activity of gemcitabine combined with irinotecan in patients with relapsed small cell lung cancer (SCLC).
  
  
  METHODS
  SCLC patients who had experienced treatment failure with one prior chemotherapy were eligible. Patients were required to have a performance status of 0-2 and adequate organ function. Treatment consisted of gemcitabine (1,000 mg/m(2)) and irinotecan (150 mg/m(2)) on days 1 and 15 of a 28 day cycle.
  
  
  RESULTS
  Thirty-one patients were enrolled and 30 patients received protocol treatment (10 had refractory disease and 20 had sensitive disease). The median age was 64 years, and the median performance status was one. An objective response was obtained in 36.7% (95% CI: 17.3.1-56.0%) of the patients. The median overall survival time was 14.4 months, and the 1 year survival rate was 51%. The chief grade 3/4 toxicities included neutropenia (42%), thrombocytopenia (3%), diarrhea (9%), and liver dysfunction (3%). The only grade 4 toxicities were one case of grade 4 neutropenia (3.3%) and one case of grade 4 thrombocytopenia (3.3%).
  
  
  CONCLUSIONS
  Gemcitabine plus irinotecan is an active regimen that seems to be well-tolerated by patients with previously treated SCLC.
authors.affiliation: Thoracic Oncology Center, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Ariake 3-10-6, Koto-ku, Tokyo 135-8550, Japan.
authors.forename: Fumiyoshi
authors.initials: F
authors.lastname: Ohyanagi
authors.forename: Atsushi
authors.initials: A
authors.lastname: Horiike
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Okano
authors.forename: Yukitoshi
authors.initials: Y
authors.lastname: Satoh
authors.forename: Sakae
authors.initials: S
authors.lastname: Okumura
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Ishikawa
authors.forename: Ken
authors.initials: K
authors.lastname: Nakagawa
authors.forename: Takeshi
authors.initials: T
authors.lastname: Horai
authors.forename: Makoto
authors.initials: M
authors.lastname: Nishio
mesh_terms: D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D018288:Carcinoma, Small Cell / Q000188:drug therapy*; D015331:Cohort Studies; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D003841:Deoxycytidine; D000077146:Irinotecan; D002166:Camptothecin; D000093542:Gemcitabine