title: Should elderly non-small-cell lung cancer patients be offered elderly-specific trials? Results of a pooled analysis from the North Central Cancer Treatment Group.
abstract: OBJECTIVE
  To answer the question, "should elderly non-small-cell lung cancer patients be offered elderly-specific trials?"
  
  
  METHODS
  The North Central Cancer Treatment Group (NCCTG) performed a pooled analysis of elderly patients who participated in elderly-specific trials (required age > or = 65 years) and age-unspecified trials (required age > or = 18 years). Between 1998 and 2000, all NCCTG non-small-cell lung cancer (NSCLC) patients with incurable cancer, age > or = 65 years, and receiving first-line chemotherapy were included. A total of 118 elderly patients participated in elderly-specific trials, and 108, in age-unspecified trials. Demographics and outcomes were compared based on trial type.
  
  
  RESULTS
  The median age of elderly patients in elderly-specific trials was greater: median (range): 73 years (65 to 87) and 70 years (65 to 85), respectively (P < .001), as was the percentage older than 80 years: 17% and 3%, respectively (P = .0008). Median survival times were 232 and 302 days, respectively (P = .08). After adjustment for baseline age, Eastern Cooperative Oncology Group performance score, cancer stage, and body mass index, this survival difference was not statistically significant (hazard ratio = 1.25; P = .16). Grade 3 or worse nonhematologic adverse event rates were greater in age-unspecified trials (81% v 57%, respectively; P < .001), as were grade 3 or worse hematologic events (68% v 10%, respectively; P < .001).
  
  
  CONCLUSIONS
  Elderly patients in NSCLC elderly-specific trials suffered lower rates of severe adverse events with no statistically significant differences in survival. It seems that elderly-specific trials are providing quality care and helping to define optimal cancer therapy in the elderly, particularly among the "oldest of the old."
authors.affiliation: Department of Oncology, Mayo Clinic, Rochester, MN 55905, USA. jatoi.aminah@mayo.edu
authors.forename: Aminah
authors.initials: A
authors.lastname: Jatoi
authors.forename: Shauna
authors.initials: S
authors.lastname: Hillman
authors.forename: Philip
authors.initials: P
authors.lastname: Stella
authors.forename: Erin
authors.initials: E
authors.lastname: Green
authors.forename: Alex
authors.initials: A
authors.lastname: Adjei
authors.forename: Suresh
authors.initials: S
authors.lastname: Nair
authors.forename: Edith
authors.initials: E
authors.lastname: Perez
authors.forename: Bipinkur
authors.initials: B
authors.lastname: Amin
authors.forename: Steven E
authors.initials: SE
authors.lastname: Schild
authors.forename: Rene
authors.initials: R
authors.lastname: Castillo
authors.forename: James R
authors.initials: JR
authors.lastname: Jett
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000375:Aging; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D011379:Prognosis; D012189:Retrospective Studies; D016019:Survival Analysis