title: Phase III study of docetaxel compared with vinorelbine in elderly patients with advanced non-small-cell lung cancer: results of the West Japan Thoracic Oncology Group Trial (WJTOG 9904).
abstract: OBJECTIVE
  Docetaxel has shown activity in elderly patients with advanced non-small-cell lung cancer (NSCLC). This randomized phase III trial evaluated the efficacy and safety of docetaxel versus vinorelbine (the current standard treatment) in elderly patients.
  
  
  METHODS
  Chemotherapy-naïve patients age 70 years or older with stage IIIB/IV NSCLC and performance status 2 or lower were eligible. Patients randomly received docetaxel 60 mg/m2 (day 1) or vinorelbine 25 mg/m2 (days 1 and 8) every 21 days for four cycles. The primary end point was overall survival. Overall disease-related symptom improvement was assessed using an eight-item questionnaire.
  
  
  RESULTS
  In total, 182 patients were enrolled. Median age was 76 years (range, 70 years to 86 years). There was no statistical difference in median overall survival with docetaxel versus vinorelbine (14.3 months v 9.9 months; hazard ratio, 0.780; 95% CI, 0.561 to 1.085; P = .138). There was a significant difference in median progression-free survival (5.5 months v 3.1 months; P < .001). Response rates were also significantly improved with docetaxel versus vinorelbine (22.7% v 9.9%; P = .019). The most common grade 3 to 4 toxicities were neutropenia (82.9% for docetaxel; 69.2% for vinorelbine; P = .031) and leukopenia (58.0% for docetaxel; 51.7% for vinorelbine). Other toxicities were mild and generally well tolerated. Docetaxel improved overall disease-related symptoms over vinorelbine (odds ratio, 1.86; 95% CI, 1.09 to 3.20).
  
  
  CONCLUSIONS
  Docetaxel improved progression-free survival, response rate, and disease-related symptoms versus vinorelbine. Overall survival was not statistically significantly improved at this time. Docetaxel monotherapy may be considered as an option in the standard treatment of elderly patients with advanced NSCLC.
authors.affiliation: Department of Respiratory Medicine, Osaka City University Medical School, Osaka, Japan. shinzohykudoh@med.osaka-cu.ac.jp
authors.forename: Shinzoh
authors.initials: S
authors.lastname: Kudoh
authors.forename: Koji
authors.initials: K
authors.lastname: Takeda
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Nakagawa
authors.forename: Minoru
authors.initials: M
authors.lastname: Takada
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Katakami
authors.forename: Kaoru
authors.initials: K
authors.lastname: Matsui
authors.forename: Tetsu
authors.initials: T
authors.lastname: Shinkai
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Sawa
authors.forename: Isao
authors.initials: I
authors.lastname: Goto
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Semba
authors.forename: Takashi
authors.initials: T
authors.lastname: Seto
authors.forename: Masahiko
authors.initials: M
authors.lastname: Ando
authors.forename: Taroh
authors.initials: T
authors.lastname: Satoh
authors.forename: Naruo
authors.initials: N
authors.lastname: Yoshimura
authors.forename: Shunichi
authors.initials: S
authors.lastname: Negoro
authors.forename: Masahiro
authors.initials: M
authors.lastname: Fukuoka
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007564:Japan; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D016017:Odds Ratio; D011446:Prospective Studies; D011788:Quality of Life; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; D014747:Vinblastine; D000077235:Vinorelbine