title: Pulmonary toxicity in patients treated with gemcitabine plus vinorelbine or docetaxel for advanced non-small cell lung cancer: outcome data on a randomized phase II study.
abstract: Studies with the gemcitabine/vinorelbine (GV) or the gemcitabine/docetaxel (GD) combinations have shown similar efficacy and less toxicity compared to platinum-based chemotherapies, in patients with advanced non-small-cell lung cancer (NSCLC). The present trial was designed to test the efficacy and safety of both, GV and GD, combinations. Chemotherapy-naïve patients (n=39)<or=75 years of age, KPS>or=60% and adequate hematological, renal and hepatic function were randomly assigned to receive G 1,000 mg/m2+either V 25 mg/m2 or D 35 mg/m2 (all of which were administered i.v.) on days 1 and 8 every 21 days. Baseline characteristics were comparable in GV (n=20) and GD (n=19) groups. Results indicated objective response of 7 (35%) vs 6 (31%) patients and median time-to-treatment failure of 120 versus 90 days in the GV and GD arms, respectively. The most common non-hematological toxicities were (GV vs GD): grade 2-4 pulmonary toxicity in 1 (5%) vs 7 (37%); grade 2-3 diarrhea 0 versus 4 (21%) and edema 1 (5%) vs 3 (16%); grade 3-4 hematological toxicities occurred in 3 (15%) vs 1 (5%) patients. Our results indicate that the combination of gemcitabine/docetaxel does not have a favorable safety profile with this schedule of administration, particularly in terms of pulmonary toxicity.
authors.affiliation: Servicio de Oncología Médica, Hospital Central de Asturias, Julián Clavería s/n, 33006, Oviedo, Asturias, Spain. eestebang@seom.org
authors.forename: Emilio
authors.initials: E
authors.lastname: Esteban
authors.forename: Noemi
authors.initials: N
authors.lastname: Villanueva
authors.forename: Isabel
authors.initials: I
authors.lastname: Muñiz
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Fernández
authors.forename: Joaquin
authors.initials: J
authors.lastname: Fra
authors.forename: Maria
authors.initials: M
authors.lastname: Luque
authors.forename: Paula
authors.initials: P
authors.lastname: Jiménez
authors.forename: Beatriz
authors.initials: B
authors.lastname: Llorente
authors.forename: Marta
authors.initials: M
authors.lastname: Capelan
authors.forename: José M
authors.initials: JM
authors.lastname: Vieitez
authors.forename: Enrique
authors.initials: E
authors.lastname: Estrada
authors.forename: José M
authors.initials: JM
authors.lastname: Buesa
authors.forename: Angel
authors.initials: A
authors.lastname: Jiménez-Lacave
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D003967:Diarrhea / Q000139:chemically induced; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008171:Lung Diseases / Q000139:chemically induced*; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D011446:Prospective Studies; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine; D000093542:Gemcitabine