title: Therapy choices among older patients with lung carcinoma: an evaluation of two trials of the Cancer and Leukemia Group B.
abstract: BACKGROUND
  Despite a greater risk of malignancy and a higher cancer mortality rate for patients age > 65 years, bias in accruing older patients to clinical trials persists. The results from two National Cancer Institute-approved cooperative group trials (Cancer and Leukemia Group B trial 8931 [CALGB 8931] and CALGB 9130) were analyzed retrospectively to determine the participation, tolerance of treatment, and outcome of patients age > 70 years.
  
  
  METHODS
  Five hundred fifteen patients with locally advanced or metastatic nonsmall cell lung carcinoma participated in two separate, randomized, Phase III clinical trials conducted by CALGB. Retrospective evaluation of patients by four distinct age cohorts (< 50 years, 50-59 years, 60-69 years, and > 70 years) was carried out to determine differences in toxicity, response, and survival.
  
  
  RESULTS
  No patients age > 80 were entered on either study, even though there was no age restriction in the study eligibility criteria. No significant differences were seen in response, survival, or continuation of treatment based on age cohort. Significantly increased leukocyte toxicity was seen in older cohorts without a concomitant increase in severe or worse infectious events.
  
  
  CONCLUSIONS
  No patients age > 80 were entered on either trial despite their potential eligibility. Patients in the oldest cohort showed no negative impact of age on treatment tolerance, response to treatment, or survival. The aggregate clinical judgment of patients and physicians can identify septuagenarians who should not be denied active consideration for aggressive management of their advanced nonsmall cell lung carcinoma.
authors.affiliation: Gastrointestinal Program Office, H. Lee Moffitt Cancer Center, Tampa, Florida 33612, USA. rochalcm@moffitt.usf.edu
authors.forename: Caio Max S
authors.initials: CM
authors.lastname: Rocha Lima
authors.forename: James E
authors.initials: JE
authors.lastname: Herndon
authors.forename: Michael
authors.initials: M
authors.lastname: Kosty
authors.forename: Gerald
authors.initials: G
authors.lastname: Clamon
authors.forename: Mark R
authors.initials: MR
authors.lastname: Green
mesh_terms: D000328:Adult; D017677:Age Distribution; D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000556:secondary / Q000628:therapy*; D002986:Clinical Trials as Topic; D017326:Clinical Trials, Phase III as Topic; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology / Q000628:therapy*; D008875:Middle Aged; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D016019:Survival Analysis