Second-line chemotherapy with irinotecan and vinorelbine in stage IIIB and IV non-small-cell lung cancer: a phase II study
González Cao M., Aramendía J.M., Salgado E., Aristu J., Martínez Monge R., Algarra S.M., Ordoñez J.M., Brugarolas A.
Department of Oncology, Clínica Universitaria de Navarra, University of Navarra, Spain.
The purpose of this study was to evaluate the efficacy and tolerance of combined irinotecan and vinorelbine in previously treated patients with stage IIIB and IV non-small-cell lung cancer (NSCLC). Thirty-three patients with NSCLC (7 stage IIIB and 26 stage IV) were enrolled.
All had been previously treated with cisplatin, paclitaxel, and gemcitabine as first-line chemotherapy. In addition, 24 patients had received radiotherapy. Irinotecan (300 mg/m(2)) was administered on day 1 and vinorelbine (30 mg/m(2)) on days 1 and 14, every 4 weeks. Partial response was achieved in 3 patients (9%; 95% CI: 2-24%), stable disease (SD) in 13 (39%; 95% CI: 23-58%), whereas 17 patients progressed (51%; 95% CI: 33-69%). Median event-free survival was 10 weeks and median overall survival was 25 weeks. Three patients were event free at the end of the study with a follow-up of 40, 73, and 75 weeks. Toxicity was mild, with leukopenia grade III-IV in 8.6% of cycles. No episodes of diarrhea III-IV were observed. Three patients died early after administration of this combination, one of them in the context of severe leukopenia and thrombocytopenia.
Approximately 50% of patients treated with CPT-11 and vinorelbine in combination show partial response or stable disease with minimal toxicity.
CITATION Am J Clin Oncol. 2002 Oct;25(5):480-4