title: Gemcitabine (GEM) and vindesine (VDS) in advanced non-small cell lung cancer (NSCLC): a phase II study in elderly or poor performance status patients.
abstract: The aim of the study was to assess the activity and tolerability of the combination of gemcitabine (GEM) and vindesine (VDS) in elderly or poor performance patients with advanced non-small cell lung cancer. Forty four patients (36 males and 8 females with a median age of 70 years and a median Karnofsky performance score of 60) were recruited between January 1998 and June 2001; 9 (20.5%) were stage IIIB patients and 35 (79.5%) were stage IV patients; 20 (45.5%) had squamous carcinoma and 24 (54.5%) non-squamous carcinoma. The patients received GEM 1000 mg/m(2) and VDS 3mg/m(2) (max 5mg) on days 1 and 8 every 3 weeks, and were all evaluable for response and toxicity: 17 (38.6%) were partial responders, 17 (38.6%) experienced stable disease, and 10 (22.3%) progressive disease. Grade 3-4 anemia, neutropenia and thrombocytopenia were observed in, respectively, 6.8, 9.1 and 2.3% of the patients, and grade 2-3 fatigue, paresthesias and skin toxicity in, respectively, 11.4, 20.4 and 2.3%. After a median follow-up of 54 months, 43/44 patients died; median survival was 12 months, and a clinical benefit was observed in 54.5% of cases. GEM plus VDS is an active and well-tolerated schedule.
authors.affiliation: Department of Medical Oncology, University of Verona, Italy. antonio.santo@univr.it
authors.forename: Antonio
authors.initials: A
authors.lastname: Santo
authors.forename: Giovenzio
authors.initials: G
authors.lastname: Genestreti
authors.forename: Alberto
authors.initials: A
authors.lastname: Terzi
authors.forename: Paolo
authors.initials: P
authors.lastname: Azzoni
authors.forename: Teodoro
authors.initials: T
authors.lastname: Sava
authors.forename: Pietro
authors.initials: P
authors.lastname: Manno
authors.forename: Annamaria
authors.initials: A
authors.lastname: Molino
authors.forename: Cristian
authors.initials: C
authors.lastname: Pattaro
authors.forename: Rocco
authors.initials: R
authors.lastname: Micciolo
authors.forename: Gian Luigi
authors.initials: GL
authors.lastname: Cetto
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018450:Disease Progression; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D010146:Pain; D013997:Time Factors; D016896:Treatment Outcome; D014751:Vindesine / Q000008:administration & dosage*; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D014751:Vindesine; D000093542:Gemcitabine