title: Second-line treatment with irinotecan plus cisplatin vs cisplatin of patients with advanced non-small-cell lung cancer pretreated with taxanes and gemcitabine: a multicenter randomised phase II study.
abstract: The aim of this study was to compare the irinotecan/cisplatin regimen with cisplatin as second-line chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC) pretreated with a taxane/gemcitabine regimen. Patients (n = 147) with stage IV NSCLC pretreated with a taxane/gemcitabine regimen were randomly assigned to receive either irinotecan (110 mg m(-2), day 1 and 100 mg m(-2), day 8) and cisplatin (80 mg m(-2), day 8) (IC; n = 74) or CDDP (80 mg m(-2), day 1) (C; n = 73) every 3 weeks. Patients treated with IC and C had a median survival of 7.8 and 8.8 months, respectively (P = 0.933). The 1-year survival rate was 34.3% for IC-treated patients and 31.7% for C-treated patients. Cox's regression analysis revealed that response to treatment (hazard ratio (HR) = 2.787; 95% confidence interval (CI): 1.1578-4.922) and performance status (HR = 1.865; 95% CI: 1.199-2.872) was independent prognostic factors for survival. Overall response rate was 22.5% (95% CI: 12.8-32.2%) for IC-treated patients and 7.0% (95% CI: 1.15-13.6%) for C-treated patients (P = 0.012); tumour growth control (partial remission (PR) + stable disease (SD)) was observed in 26 (38%) IC and 25 (36%) C patients (P = 0.878). There was no difference in terms of quality of life between the two chemotherapy arms. The incidence of febrile neutropenia, grade 3 and 4 neutropenia and grade 3 and 4 diarrhoea was significantly higher in the IC- than the C-treated patients. Other toxicities were mild. There were no treatment-related deaths in either arm. The IC regimen did not confer a survival benefit compared with C as second-line treatment of patients with advanced NSCLC pretreated with a taxane/gemcitabine regimen, despite its better efficacy in terms of response rate.
authors.affiliation: Department of Medical Oncology, University General Hospital of Heraklion, Crete, Greece. georgoul@med.uoc.gr
authors.forename: V
authors.initials: V
authors.lastname: Georgoulias
authors.forename: A
authors.initials: A
authors.lastname: Agelidou
authors.forename: K
authors.initials: K
authors.lastname: Syrigos
authors.forename: A
authors.initials: A
authors.lastname: Rapti
authors.forename: M
authors.initials: M
authors.lastname: Agelidou
authors.forename: J
authors.initials: J
authors.lastname: Nikolakopoulos
authors.forename: A
authors.initials: A
authors.lastname: Polyzos
authors.forename: A
authors.initials: A
authors.lastname: Athanasiadis
authors.forename: E
authors.initials: E
authors.lastname: Tselepatiotis
authors.forename: N
authors.initials: N
authors.lastname: Androulakis
authors.forename: K
authors.initials: K
authors.lastname: Kalbakis
authors.forename: G
authors.initials: G
authors.lastname: Samonis
authors.forename: D
authors.initials: D
authors.lastname: Mavroudis
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage; 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; D010349:Patient Compliance; D011446:Prospective Studies; D016019:Survival Analysis; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin; D000093542:Gemcitabine