1. ¹Department of Medical Oncology, University General Hospital of Heraklion, PO Box 1352, 711 10 Heraklion, Crete, Greece
2. ²1st Department of Pulmonary Disease, 'Sotiria' General Hospital, Athens, Greece
3. ³Medical Oncology Unit, 3rd University Department of Medicine, 'Sotiria' General Hospital, Athens, Greece
4. ⁴8th Department of Pulmonary Diseases, 'Sotiria' General Hospital, Athens, Greece
5. ⁵2nd Department of Pulmonary Diseases, 'Sismanoglion' General Hospital of Athens, Athens, Greece
6. ⁶1st Department of Pulmonary Diseases, 'Sismanoglion' General Hospital of Athens, Athens, Greece
7. ⁷Medical Oncology Unit, University Department of Propedeutic Medicine, 'Laikon' General Hospital of Athens, Athens, Greece
8. ⁸Department of Medical Oncology, General Hospital of Larissa, Larissa, Greece
9. ⁹Department of Internal Medicine, 'Patision' General Hospital of Athens, Athens, Greece

Correspondence: Dr V Georgoulias, E-mail: georgoul@med.uoc.gr

Received 21 January 2005; Revised 20 July 2005; Accepted 21 July 2005; Published online 20 September 2005.

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.