title: Phase II study of docetaxel/vinorelbine in patients with non-small-cell-lung cancer previously treated with platinum-based chemotherapy.
abstract: The aim of this phase II trial was to assess the efficacy and tolerability of docetaxel/vinorelbine as second-line therapy. Thirty-two patients with a performance status (PS) of <or= 2 (5 with locally advanced and 27 with metastatic non-small-cell lung cancer [NSCLC]) who were previously treated with platinum-based chemotherapy, were recruited. Docetaxel 75 mg/m2 on day 1 and vinorelbine 20 mg/m2 on days 1 and 5 were administered every 3 weeks with dexamethasone premedication but without prophylactic granulocyte colony-stimulating factor and antibiotics. The overall response rate (intent-to-treat analysis) was 9.5%, including 3 patients with a partial response, 15 (47%) with stable disease, and 9 (28%) with progressive disease. Myelosupression was the limiting toxicity, with 8 episodes of febrile neutropenia and 3 deaths due to sepsis. Median overall survival and progression-free survival were 25 weeks and 13 weeks, respectively. Patients with a PS of 2 (P < 0.02) and elevated lactate dehydrogenase (P < 0.01) had a worse prognosis. Histology of adenocarcinoma appeared to positively influence survival (P = 0.09). Our study confirms that the docetaxel/vinorelbine schedule has activity in NSCLC patients pretreated with platinum-based therapies.
authors.affiliation: Department of Medical Oncology, Hospital de Cruces, Osakidetza, Basque Country, Spain.
authors.forename: Alberto
authors.initials: A
authors.lastname: Muñoz
authors.forename: Itziar
authors.initials: I
authors.lastname: Rubio
authors.forename: Juan Manuel
authors.initials: JM
authors.lastname: Mañé
authors.forename: Josefa
authors.initials: J
authors.lastname: Ferreiro
authors.forename: Ricardo
authors.initials: R
authors.lastname: Fernández
authors.forename: Guadalupe
authors.initials: G
authors.lastname: Abón
authors.forename: Gonzalo López
authors.initials: GL
authors.lastname: de Argumedo
authors.forename: Natalia
authors.initials: N
authors.lastname: Fuente
authors.forename: José Ramón
authors.initials: JR
authors.lastname: Barceló
authors.forename: Guillermo
authors.initials: G
authors.lastname: López-Vivanco