Should Elderly Non-Small-Cell Lung Cancer Patients be Offered ElderlySpecific Trials? Results of a Pooled Analysis from the North Central Cancer Treatment Group.

PURPOSE: To answer the question, should elderly non-small-cell lung cancer patients be offered elderly-specific trials? PATIENTS AND METHODS: The North Central Cancer Treatment Group (NCCTG) performed a pooled analysis of elderly patients who participated in elderly-specific trials (required age \u3e or = 65 years) and age-unspecified trials (required age \u3e or = 18 years). Between 1998 and 2000, all NCCTG non-small-cell lung cancer (NSCLC) patients with incurable cancer, age \u3e 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 \u3c .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 \u3c .001), as were grade 3 or worse hematologic events (68% v 10%, respectively; P \u3c .001). CONCLUSION: 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