title: Gemcitabine and irinotecan for patients with untreated extensive stage small cell lung cancer: SWOG 0119.
abstract: BACKGROUND
  To evaluate the activity of a nonplatinum-, nonetoposide-containing regimen for patients with extensive stage small cell lung cancer.
  
  
  METHODS
  Patients with untreated extensive stage small cell lung cancer were treated with gemcitabine 1000 mg/m2 and irinotecan 100 mg/m2 on days 1 and 8 of a 21-day cycle for a maximum of six cycles. Patients with brain metastases were eligible if asymptomatic or controlled after radiation.
  
  
  RESULTS
  Eighty-four eligible patients with untreated extensive stage small cell lung cancer with adequate organ function and a performance status of 0-2 were accrued. The median age was 64 years (range, 42-85) and 45 (54%) were women. Six cycles were completed by 28 (33%) patients. Some degree of diarrhea occurred in 57% (grade 3/4, 18%). Other grade 3/4 toxicities were neutropenia (26%), anemia (10%), thrombocytopenia (8%), febrile neutropenia (5%), fatigue (11%), nausea (10%), and vomiting (8%). The response rate was 32% (95% confidence interval: 22%-43%) among the 81 patients with measurable disease. The median survival was 8.5 months (95% confidence interval: 7.0-9.8) with 1- and 2-year survival rates of 26% and 7%, respectively. Salvage therapy data were captured by prospective collection, and only 50% of patients were treated secondarily.
  
  
  CONCLUSIONS
  The overall response rate with the combination of gemcitabine and irinotecan was disappointing, and the median survival rate was lower than expected. Further development of this combination in small cell lung cancer is not recommended.
authors.affiliation: University of Utah Health Science Center, Huntsman Cancer Institute, Salt Lake City, Utah 84112, USA. wallace.akerley@hci.utah.edu
authors.forename: Wallace
authors.initials: W
authors.lastname: Akerley
authors.forename: Jason
authors.initials: J
authors.lastname: McCoy
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Hesketh
authors.forename: J Wendall
authors.initials: JW
authors.lastname: Goodwin
authors.forename: James D
authors.initials: JD
authors.lastname: Bearden
authors.forename: James N
authors.initials: JN
authors.lastname: Atkins
authors.forename: Kari
authors.initials: K
authors.lastname: Chansky
authors.forename: John J
authors.initials: JJ
authors.lastname: Crowley
authors.forename: David R
authors.initials: DR
authors.lastname: Gandara
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy / Q000556:secondary; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D011446:Prospective Studies; D016879:Salvage Therapy; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000077146:Irinotecan; D002166:Camptothecin; D000093542:Gemcitabine