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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

From the Departments of Oncology, Biostatistics, and Medicine, Mayo Clinic, Rochester, MN; St Joseph Mercy Health System, Ann Arbor, MI; Geisinger Clinic and Medical Center, Danville, PA; Department of Hematology/Oncology, Mayo Clinic, Jacksonville, FL; Mid-Dakota Clinic, Bismarck, ND; Department of Radiation Oncology, Mayo Clinic, Scottsdale, AZ; Oschner Clinic, New Orleans, LA

Address reprint requests to Aminah Jatoi, MD, Mayo Clinic, 200 First St SW, Rochester, MN 55905; e-mail: jatoi.aminah{at}mayo.edu

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 65 years) and age-unspecified trials (required age 18 years). Between 1998 and 2000, all NCCTG non–small-cell lung cancer (NSCLC) patients with incurable cancer, age 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).

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."

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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