title: An overview of 48 elderly-specific clinical trials of systemic chemotherapy for advanced non-small cell lung cancer.
abstract: OBJECTIVE
  The aim of the present study was to identify elderly-specific clinical trials for advanced non-small cell lung cancer (NSCLC) and to clarify the study design and patient characteristics entered of each of these trials.
  
  
  METHODS
  We used the MEDLINE database to select prospective clinical trials evaluating the efficacy of chemotherapy in elderly patients with advanced NSCLC.
  
  
  RESULTS
  Our literature search yielded 48 prospective clinical trials between 1990 and 2003, involving a total of 2648 elderly patients with advanced NSCLC. The median number of patients treated per trial was 36. In 23 (48%) of the 48 trials, only the abstract was available. In 44 trials (92%), elderly patients were defined using their calendar age, and the age of 70 years was the most frequently used lower limit for inclusion. Vinorelbine was the most widely studied chemotherapy agent in elderly patients.
  
  
  CONCLUSIONS
  Our review revealed that (i) the definition of "elderly" varied from trial to trial, and elderly patients were simply defined using calendar age in the clinical trials; (ii) the quality of elderly-specific trials were generally poor, mainly because of their small sample size.
authors.affiliation: Department of Medicine II, Okayama University Medical School, 2-5-1 Shikata-cho, Okayama 700-8558, Japan. khotta@md.okayama-u.ac.jp
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Hotta
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ueoka
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Kiura
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tabata
authors.forename: Mitsune
authors.initials: M
authors.lastname: Tanimoto
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000375:Aging; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D004608:Eligibility Determination; D006304:Health Status; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D009626:Terminology as Topic