title: Second-line chemotherapy with irinotecan and vinorelbine in stage IIIB and IV non-small-cell lung cancer: a phase II study.
abstract: 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.
authors.affiliation: Department of Oncology, Clinica Universitaria de Navarra, University of Navarra, Spain.
authors.forename: María
authors.initials: M
authors.lastname: González Cao
authors.forename: Jose Manuel
authors.initials: JM
authors.lastname: Aramendía
authors.forename: Esteban
authors.initials: E
authors.lastname: Salgado
authors.forename: Javier
authors.initials: J
authors.lastname: Aristu
authors.forename: Rafael
authors.initials: R
authors.lastname: Martínez Monje
authors.forename: Salvador Martín
authors.initials: SM
authors.lastname: Algarra
authors.forename: Jose Manuel
authors.initials: JM
authors.lastname: Ordoñez
authors.forename: Antonio
authors.initials: A
authors.lastname: Brugarolas
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D016019:Survival Analysis; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D000077146:Irinotecan; D000077235:Vinorelbine; D002166:Camptothecin