Revisiting a longstanding clinical trial exclusion criterion: impact of prior cancer in early-stage lung cancer

Background: Early-stage lung cancer represents a key focus of numerous multicenter clinical trials, but common exclusion criteria such as a prior cancer diagnosis may limit enrollment. We examined the prevalence and prognostic impact of a prior cancer diagnosis among patients with early-stage lung cancer. Methods: We identified patients465 years of age with early-stage lung cancer diagnosed 1996-2009 in the Surveillance, Epidemiology, and End Results-Medicare linked database. Prior cancers were characterized by type, stage, and timing with respect to the lung cancer diagnosis. All-cause and lung cancer specific-survival rates were compared between patients with and without prior cancer using Cox regression analyses and propensity scores. Results: Among 42,910 patients with early-stage lung cancer, one-fifth (21%) had a prior cancer. The most common prior cancers were prostate (21%), breast (18%), gastrointestinal (17%), and other genitourinary (15%). Most prior cancers were localized, and 61% were diagnosed within 5 years of the lung cancer diagnosis. There was no difference in all-cause survival between patients with and without prior cancer (hazard ratio [HR] 1.01; P = 0.52). Lung cancer specific survival was improved among patients with prior cancer (HR 0.79; P < 0.001). Conclusions: A prior cancer history may exclude a substantial proportion of patients with early-stage lung cancer from enrollment in clinical trials. Without adverse effect on clinical outcomes, inclusion of patients age 465 years with prior cancer in clinical trials should be considered to improve study accrual, completion rates, and generalizability.