title: A phase II study of days 1 and 8 combination of docetaxel plus gemcitabine for the second-line treatment of patients with advanced non-small-cell lung cancer and good performance status.
abstract: OBJECTIVE
  We conducted a phase II trial to evaluate the efficacy and toxicity of a combination consisting of second-line docetaxel and gemcitabine in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy.
  
  
  METHODS
  
  
  
  METHODS
  histologically confirmed advanced NSCLC with progressive disease to platinum-based chemotherapy, ECOG performance status (PS) 0 or 1, and adequate kidney, liver and bone marrow function. Treatment consisted of docetaxel 36 mg/m(2) i.v. over 60 min followed by gemcitabine 1000 mg/m(2) i.v. over 30 min on days 1 and 8 of each 3-week cycle for a planned six cycles or unacceptable toxicity.
  
  
  RESULTS
  Of the 52 patients enrolled, 50 were evaluable for response and toxicity. The mean age was 59 years (range 42-79), 46 male and 4 female. Histology subtypes were: adenocarcinoma 26 patients, bronchioloalveolar 1 patient, large cell carcinoma 5 patients, and squamous cell carcinoma 18 patients. Thirty-eight patients had ECOG PS 1 and 12 patients had PS 0. The median number of cycles administered was four (range 2-6). The overall response rate was 28%. The median follow-up was 9 months (range 5-34 months). The median survival time (MST) was 8.2 months (95% CI, 4-12%), and the 1-year survival was 25%. The median progression-free survival was 4.4 months (95% CI, 2-6%). In the Cox regression model, survival was only significantly affected by the PS. The median survival in patients with PS 0 was 17.8 months (95% CI, 18.8-21.8%) compared with a median survival for patients with PS 1 of 6.1 months (95% CI, 4.1-8.2%) (P=0.0057).
  
  
  RESULTS
  three patients had grade 3 anemia, three patients had grade 3 thrombocytopenia, four patients had grade 3 neutropenia and only one patient developed grade 4 febrile neutropenia. Non-hematologic toxicity was also mild; the most frequent was asthenia, with grade 3 in eight patients (16%), and one patient with grade 4.
  
  
  CONCLUSIONS
  This regimen of docetaxel in combination with gemcitabine in advanced second-line NSCLC is an active and safe regimen.
authors.affiliation: Medical Oncology Section, Hospital Regional Universitario Carlos Haya, Málaga, Spain. manuelcobodols@yahoo.es
authors.forename: Manuel
authors.initials: M
authors.lastname: Cobo
authors.forename: Vanesa
authors.initials: V
authors.lastname: Gutiérrez
authors.forename: Julia
authors.initials: J
authors.lastname: Alcaide
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Alés
authors.forename: Esther
authors.initials: E
authors.lastname: Villar
authors.forename: Silvia
authors.initials: S
authors.lastname: Gil
authors.forename: Gema
authors.initials: G
authors.lastname: Durán
authors.forename: Joaquina
authors.initials: J
authors.lastname: Martínez
authors.forename: Francisco
authors.initials: F
authors.lastname: Carabantes
authors.forename: Juan J
authors.initials: JJ
authors.lastname: Bretón
authors.forename: Manuel
authors.initials: M
authors.lastname: Benavides
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000401:mortality; D016019:Survival Analysis; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine