title: A multicenter phase II study of the combination of irinotecan and gemcitabine in previously treated patients with small-cell lung cancer.
abstract: OBJECTIVE
  To evaluate efficacy and toxicity of the combination of irinotecan and gemcitabine in pretreated patients having small-cell lung cancer.
  
  
  METHODS
  Thirty-one patients (median age 60 years, performance status 0-1 in 87% and 2 in 13% of the patients) with limited or extensive-stage disease, refractory or relapsing after at least one prior chemotherapy regimen, received gemcitabine 1,000 mg/m(2) on days 1 and 8 and irinotecan 300 mg/m(2) on day 8, every 21 days. Sixteen (52%) patients had sensitive and 15 (48%) refractory disease. Fifteen patients (48%) had received > or =2 prior regimens.
  
  
  RESULTS
  All patients were evaluable for toxicity and 26 for response analysis. A median of three (range 1-6) cycles per patient was administered. Three partial responses were documented for an overall response rate of 10% (95% CI 0.73-20.09), and disease stabilization was obtained in 7 patients (22%; intention-to-treat analysis). Two of the responders had refractory, and 1 had sensitive disease. The median time to progression was 4.5 months, the median duration of responses was 2.5 months, and the median survival time was 6 months. Grade 3-4 (WHO) neutropenia was observed in 9 patients (29%), grade 3-4 thrombocytopenia in 4 (13%), and grade 3-4 diahrrea in 3 patients (10%). Three patients experienced febrile neutropenia. No toxic deaths occurred.
  
  
  CONCLUSIONS
  The combination showed modest activity in this patient group with a poor prognosis. Thus we believe it merits further investigation in the treatment of patients with small-cell lung cancer who have failed one prior chemotherapy regimen.
authors.affiliation: Department of Medical Oncology, University General Hospital, Heraklion, Greece.
authors.forename: Sofia
authors.initials: S
authors.lastname: Agelaki
authors.forename: Kostas
authors.initials: K
authors.lastname: Syrigos
authors.forename: Charalambos
authors.initials: C
authors.lastname: Christophylakis
authors.forename: John
authors.initials: J
authors.lastname: Boukovinas
authors.forename: John
authors.initials: J
authors.lastname: Varthalitis
authors.forename: Georgia
authors.initials: G
authors.lastname: Pavlakou
authors.forename: Athanasios
authors.initials: A
authors.lastname: Athanasiadis
authors.forename: Charalambos
authors.initials: C
authors.lastname: Kouroussis
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Vardakis
authors.forename: George
authors.initials: G
authors.lastname: Maltezakis
authors.forename: Georgia
authors.initials: G
authors.lastname: Milaki
authors.forename: Vassilis
authors.initials: V
authors.lastname: Georgoulias
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018288:Carcinoma, Small Cell / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D003841:Deoxycytidine; D000077146:Irinotecan; D002166:Camptothecin; D000093542:Gemcitabine