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.

摘要: The aim of this study was to compare the irinotecan/cisplatin regimen with cisplatin as second-line chemotherapy in patients advanced non-small-cell lung cancer (NSCLC) pretreated a taxane/gemcitabine regimen. Patients (n=147) stage IV NSCLC were randomly assigned receive either irinotecan (110 mg m−2, day 1 and 100 mg m−2, 8) (80 mg m−2, (IC; n=74) or CDDP 1) (C; n=73) every 3 weeks. treated IC C had median survival 7.8 8.8 months, respectively (P=0.933). 1-year rate 34.3% for IC-treated 31.7% C-treated patients. Cox's regression analysis revealed that response treatment (hazard ratio (HR)=2.787; 95% confidence interval (CI): 1.1578–4.922) performance status (HR=1.865; CI: 1.199–2.872) independent prognostic factors survival. Overall 22.5% (95% 12.8–32.2%) 7.0% 1.15–13.6%) (P=0.012); tumour growth control (partial remission (PR)+stable disease (SD)) observed 26 (38%) 25 (36%) (P=0.878). There no difference terms quality life between two arms. incidence febrile neutropenia, grade 4 neutropenia diarrhoea significantly higher IC- than Other toxicities mild. treatment-related deaths arm. did not confer benefit compared regimen, despite its better efficacy rate.