title: Gemcitabine plus vinorelbine in stage IIIB or IV non-small cell lung cancer (NSCLC): a multicentre phase II clinical trial.
abstract: A phase II study in patients with stage IIIB/IV non-small cell lung cancer (NSCLC) was carried out to evaluate the clinical activity and toxicity of the chemotherapeutic combination of gemcitabine+vinorelbine (GEM/VNR). Forty-five patients (40 male, 5 female) with a median age of 67 years (range 37-73) and a median ECOG performance status of 1 (range 0-2) were enrolled into the trial. Twenty patients had stage IIIB (two positive supraclavicular nodes and 20 cytologically positive pleural effusion), and 25 had stage IV NSCLC. GEM 1000 mg/m(2) diluted in 250 cc(3) of normal saline was administered iv on days 1, 8, and 15, while VNR was given 30 mg/m(2) on days 1 and 8 every 4 weeks. The median number of courses/patient was 4 (range 3-7). According to an intent-to-treat analysis 2 (4%) patients had a complete response and 16 (36%; 95% CL 22-52%) had a partial response for an overall response rate of 40% (95% CL 26-56%). Twelve (27%) patients had stable disease and 15 (33%) were considered as treatment failures. Median overall survival of the whole series was 8+ months with 33% of patients alive at 1 year. Toxicity was generally mild. WHO grade 3-4 neutropenia was recorded in 22% of cases, grade 1-3 liver toxicity in 6% of patients and neutropenia-unrelated fever in 9%. This multicentre phase II study suggests that the GEM/VNR combination regimen is an active and well tolerated regimen in patients with stage IIIB/IV NSCLC. Larger studies comparing cisplatin-based regimens to new schedules without cisplatin are warranted.
authors.affiliation: Istituto di Clinica Medica, Universita' di Palermo, Piazza delle Cliniche 2, 90127 Palermo, Italy. sepalonc@sirio-oncology.it
authors.forename: S
authors.initials: S
authors.lastname: Palmeri
authors.forename: V
authors.initials: V
authors.lastname: Leonardi
authors.forename: V
authors.initials: V
authors.lastname: Gebbia
authors.forename: M T
authors.initials: MT
authors.lastname: De Bella
authors.forename: F
authors.initials: F
authors.lastname: Ferraù
authors.forename: G
authors.initials: G
authors.lastname: Faillú
authors.forename: M
authors.initials: M
authors.lastname: Spatafora
authors.forename: R
authors.initials: R
authors.lastname: Valenza
authors.forename: G
authors.initials: G
authors.lastname: Di Vita
authors.forename: S
authors.initials: S
authors.lastname: Vitello
authors.forename: R
authors.initials: R
authors.lastname: Carroccio
authors.forename: G
authors.initials: G
authors.lastname: Sciortino
authors.forename: M
authors.initials: M
authors.lastname: Vaglica
authors.forename: V
authors.initials: V
authors.lastname: Accurso
authors.forename: B
authors.initials: B
authors.lastname: Agostara
authors.forename: G
authors.initials: G
authors.lastname: Licata
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D014747:Vinblastine; D000077235:Vinorelbine; D000093542:Gemcitabine