title: Revisiting a longstanding clinical trial exclusion criterion: impact of prior cancer in early-stage lung cancer.
abstract: 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 patients>65 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 >65 years with prior cancer in clinical trials should be considered to improve study accrual, completion rates, and generalizability.
authors.affiliation: Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas, USA.|Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
authors.forename: Sandi L
authors.initials: SL
authors.lastname: Pruitt
authors.affiliation: Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
authors.forename: Andrew L
authors.initials: AL
authors.lastname: Laccetti
authors.affiliation: Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
authors.forename: Lei
authors.initials: L
authors.lastname: Xuan
authors.affiliation: Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas, USA.|Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA.|Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
authors.forename: Ethan A
authors.initials: EA
authors.lastname: Halm
authors.affiliation: Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas, USA.|Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA.|Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
authors.forename: David E
authors.initials: DE
authors.lastname: Gerber
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality* / Q000473:pathology / Q000628:therapy; D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality* / Q000473:pathology / Q000628:therapy; D018288:Carcinoma, Small Cell / Q000401:mortality* / Q000473:pathology / Q000628:therapy; D002294:Carcinoma, Squamous Cell / Q000401:mortality* / Q000473:pathology / Q000628:therapy; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality* / Q000473:pathology / Q000628:therapy; D008297:Male; D009367:Neoplasm Staging; D018579:Patient Selection; D011379:Prognosis; D018426:SEER Program; D015996:Survival Rate; D013997:Time Factors