title: Docetaxel vs. vinorelbine in elderly patients with advanced non--small-cell lung cancer: a hellenic oncology research group randomized phase III study.
abstract: OBJECTIVE
  This study compared front-line treatment with docetaxel or vinorelbine in elderly patients with advanced/metastatic non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  Chemotherapy-naive patients with inoperable stage IIIB and stage IV NSCLC who were > 65 years of age with performance status (PS) of 0-2 were enrolled. Patients were assigned to receive either docetaxel 38 mg/m(2) or vinorelbine 25 mg/m(2) by intravenous (I.V.) infusion on days 1 and 8 every 3 weeks.
  
  
  RESULTS
  One hundred thirty elderly patients were enrolled in the study (docetaxel n = 66 and vinorelbine n = 64 patients). The objective response rate was 12.1% and 14.1% in patients treated with docetaxel and vinorelbine, respectively (2P = .799). The median time to tumor progression (TTP) was 2.33 and 1.9 months (2P = .298) and the median overall survival (OS) was 6.07 and 3.87 months (2P = .090) in the docetaxel and vinorelbine arms, respectively. Grade 3/4 neutropenia occurred in 4.5% and 29.7% of patients in the docetaxel arm and vinorelbine arm, respectively (2P < .001). Febrile neutropenia occurred in 1.5% and 1.6% of patients in the docetaxel arm and the vinorelbine arm, respectively (2P = .950) and the use of granulocyte colony-stimulating factor (G-CSF) was more frequent in patients treated with vinorelbine (37.1% vs. 22.5%; 2P < .001). There were no deaths from toxicity. Nonhematologic toxicity was mild.
  
  
  CONCLUSIONS
  Docetaxel has an efficacy comparable to that of vinorelbine as first-line treatment in elderly patients with NSCLC and has an acceptable toxicity profile. The trial was closed prematurely because of low accrual, thus limiting the strength of the conclusions derived.
authors.affiliation: Hellenic Oncology Research Group (HORG), 55, Lomvardou str, 11470 Athens, Greece.
authors.forename: Athanasios
authors.initials: A
authors.lastname: Karampeazis
authors.forename: Lambros
authors.initials: L
authors.lastname: Vamvakas
authors.forename: Athina
authors.initials: A
authors.lastname: Agelidou
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Kentepozidis
authors.forename: Kyriakos
authors.initials: K
authors.lastname: Chainis
authors.forename: Vassilis
authors.initials: V
authors.lastname: Chandrinos
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Vardakis
authors.forename: Athanasios G
authors.initials: AG
authors.lastname: Pallis
authors.forename: Charalambos
authors.initials: C
authors.lastname: Christophyllakis
authors.forename: Vassilis
authors.initials: V
authors.lastname: Georgoulias
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D043823:Taxoids / Q000009:adverse effects / Q000627:therapeutic use*; D014747:Vinblastine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077235:Vinorelbine
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D014747:Vinblastine; D000077235:Vinorelbine