title: Vinorelbine and paclitaxel for locoregional advanced or metastatic non-small-cell lung cancer.
abstract: A phase II trial was performed to evaluate the efficacy and toxicity of the novel combination of vinorelbine and paclitaxel as first-line chemotherapy in patients with stages IIIB and IV non-small-cell lung cancer. From January 1997 to September 1999, 34 patients (9 stage IIIB and 25 stage IV) received a regimen consisting of the following: vinorelbine 30 mg/m2 20 minutes intravenous (i.v.) infusion, days 1 and 8; and paclitaxel 135 mg/m2 3-hour i.v. (starting 1 hour after vinorelbine) on day 1. Cycles were repeated every 28 days until progression of disease or unacceptable toxicity development. The median age was 57 years (range 41-70 years); median performance status was 1. Histology was as follows: squamous cell in 24 (71%), large cell in 1 (3%), and adenocarcinoma in 9 (26%). All patients are evaluable for toxicity, whereas 30 are evaluable for response (4 patients refused treatment). Objective response was recorded in 4 of 30 patients (13%, 95% CI 1-25%). No complete response was observed. Partial response was recorded in 4 patients (13%), no change in 10 patients (34%), and progressive disease in 16 patients (53%). The median time to treatment failure was 4 months and median survival was 9 months. The limiting toxicity was myelosuppression: leukopenia in 23 patients (68%), whereas neutropenia was observed in 25 patients (78%). Peripheral neurotoxicity developed in 14 patients (41%) (without G3 or G4 episodes), and constipation (G1-G2: 10 patients), myalgia (G1-G2: 11 patients), diarrhea (G1-G2: 7 patients), and stomatitis were observed in 7 patients. Vinorelbine-paclitaxel combination showed only modest activity against locoregionally advanced or metastatic NSCLC.
authors.affiliation: Grupo Oncológico Cooperativo del Sur (G.O.C.S.), República Argentina.
authors.forename: Juan E
authors.initials: JE
authors.lastname: Pérez
authors.forename: Mario R
authors.initials: MR
authors.lastname: Machiavelli
authors.forename: Alberto O
authors.initials: AO
authors.lastname: Romero
authors.forename: Luis A
authors.initials: LA
authors.lastname: Romero Acuña
authors.forename: María E
authors.initials: ME
authors.lastname: Domínguez
authors.forename: Hebe
authors.initials: H
authors.lastname: Fasce
authors.forename: Luis
authors.initials: L
authors.lastname: Flores Acosta
authors.forename: Nora
authors.initials: N
authors.lastname: Marrone
authors.forename: Juan M
authors.initials: JM
authors.lastname: Romero Acuña
authors.forename: Mario J
authors.initials: MJ
authors.lastname: Langhi
authors.forename: Sonia
authors.initials: S
authors.lastname: Amato
authors.forename: Fabrina
authors.initials: F
authors.lastname: Bologna
authors.forename: Eduardo H
authors.initials: EH
authors.lastname: Ortiz
authors.forename: Bernardo A
authors.initials: BA
authors.lastname: Leone
authors.forename: Juan A
authors.initials: JA
authors.lastname: Lacava
authors.forename: Carlos T
authors.initials: CT
authors.lastname: Vallejo
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000556:secondary; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D011446:Prospective Studies; D016019:Survival Analysis; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D017239:Paclitaxel; D000077235:Vinorelbine