title: Salvage treatment of advanced non-small-cell lung cancer previously treated with docetaxel-based front-line chemotherapy with irinotecan (CPT-11) in combination with cisplatin.
abstract: BACKGROUND
  A phase II study was conducted in order to determine the toxicity and efficacy of the combination of CPT-11 and cisplatin, as salvage treatment in patients with advanced non-small-cell lung cancer (NSCLC), progressing after a docetaxel-based front-line regimen.
  
  
  METHODS
  Thirty-one patients (median age 61 years) with NSCLC, were enrolled. Twenty-six (84%) patients were male, twenty-five (81%) had disease stage IV, and twenty-eight (90%) had a performance status (WHO) 0-1. CPT-11 was administered as a 60-minute i.v. infusion at the dose of 100 mg/m2 on day 1 and 110 mg/m2 on day 8; cisplatin was administered at the dose of 80 mg/m2 on day 8, after CPT-11 administration. Treatment was repeated every three weeks.
  
  
  RESULTS
  A total of 110 chemotherapy cycles were administered. In an intention-to-treat analysis 7 patients (23%; 95%) Introduction confidence interval (95% CI): 8%-37%) achieved a partial response, 6 (19%) had stable disease, and 18 (58%) progressive disease. Three of responders had failed a previous docetaxel-carboplatin combination. The median duration of response was 3 months, the median TTP 8 months and the median survival for the entire group 8 months. Grade 3-4 neutropenia was observed in 16 (52%) patients and in two cases this was febrile. Grade 3 and 4 thrombocytopenia occurred in two (7%) patients, respectively. Grade 3 and 4 diarrhea was seen in 10 (33%) patients, grade 2-3 neurotoxicity in 2 (6%), and fatigue grade 2-3 in 12 (39%). Other toxicities were mild.
  
  
  CONCLUSIONS
  The combination of CPT-11 and cisplatin has manageable toxicity and interesting activity as salvage treatment of patients with advanced NSCLC, previously treated with a docetaxel-based front-line regimen.
authors.affiliation: Department of Medical Oncology, School of Medicine, University General Hospital of Heraklion, Crete, Greece. georgoul@med.uch.gr
authors.forename: S
authors.initials: S
authors.lastname: Kakolyris
authors.forename: C
authors.initials: C
authors.lastname: Kouroussis
authors.forename: K
authors.initials: K
authors.lastname: Kalbakis
authors.forename: D
authors.initials: D
authors.lastname: Mavroudis
authors.forename: J
authors.initials: J
authors.lastname: Souglakos
authors.lastname: Nvardakis
authors.forename: S
authors.initials: S
authors.lastname: Kremos
authors.forename: V
authors.initials: V
authors.lastname: Georgoulias
mesh_terms: D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000627:therapeutic use*; D000077143:Docetaxel; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016879:Salvage Therapy; D016019:Survival Analysis; D043823:Taxoids; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; D000077146:Irinotecan; D017239:Paclitaxel; D002945:Cisplatin; D002166:Camptothecin