title: Biweekly docetaxel as second-line chemotherapy of patients with advanced non-small cell lung cancer: a phase II study of the Galician Lung Cancer Group (GGCP 006-00).
abstract: This phase II trial assessed the antitumoral activity and toxicity of docetaxel 50 mg/m (1-h i.v. infusion) administered every 2 weeks as second-line treatment in 45 patients with advanced non-small cell lung cancer (NSCLC). A total of 251 infusions (median 4 per patient) were administered. The actual and relative median dose intensity values were 24.2 mg/m/week and 0.97, respectively. Thirty-seven patients were evaluable for tumor response. The overall response rate was 20% [95% confidence interval (CI) 8-32%] and included one complete response (2%) and eight partial responses (18%). Stable disease was found in seven patients (16%). With a median follow-up of 4 months, the median time to disease progression was 2.8 months (95% CI 1.9-3.7), the median overall survival was 4.0 months (95% CI 3.4-4.6) and the 1-year survival rate was 23% (95% CI 9-37). The every-2-weeks docetaxel schedule was well tolerated. Grade 3/4 non-hematological toxicities showed rates of 5% or less of patients and 2% or less of cycles. The main grade 3/4 hematological toxicity was neutropenia (16% of patients and 8% of cycles). No febrile neutropenia was found. Nevertheless, one toxic death was reported. We conclude that the biweekly docetaxel schedule showed an antitumoral activity similar to that found with the every-3-weeks or weekly docetaxel schedule in a second-line setting for advanced NSCLC. This antitumoral effect was associated with a marked reduction in hematological toxicity, therefore suggesting that this new docetaxel schedule might be useful in the design of combined second-line schedules for treating NSCLC.
authors.affiliation: C. Hospitalario Xeral-Calde, Lugo, Spain. sergio.vazquez.estevez@sergas.es
authors.forename: Sergio
authors.initials: S
authors.lastname: Vázquez
authors.forename: Carlos
authors.initials: C
authors.lastname: Grande
authors.forename: Margarita
authors.initials: M
authors.lastname: Amenedo
authors.forename: José Luis
authors.initials: JL
authors.lastname: Fírvida
authors.forename: Martín
authors.initials: M
authors.lastname: Lázaro
authors.forename: Guillermo
authors.initials: G
authors.lastname: Alonso
authors.forename: Teresa
authors.initials: T
authors.lastname: Curiel
authors.forename: Gerardo
authors.initials: G
authors.lastname: Huidobro
authors.forename: José Ramón
authors.initials: JR
authors.lastname: Mel
authors.forename: Manuel
authors.initials: M
authors.lastname: Ramos
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000556:secondary; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000077143:Docetaxel; D004334:Drug Administration Schedule; D023381:Endpoint Determination; D006801:Humans; D007262:Infusions, Intravenous; D008113:Liver Neoplasms / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008207:Lymphatic Metastasis; D008875:Middle Aged; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel