Clinical Study

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

  • British Journal of Cancer volume 116, pages 717725 (14 March 2017)
  • doi:10.1038/bjc.2017.27
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Presented in abstract form at the Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, USA, June 3–7, 2016.

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.

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Change history

  • Corrected online 14 March 2017

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Acknowledgements

This work was supported by the National Cancer Institute (NCI) (1R03CA191875-01A1; to DEG, SLP; EAH, LX); NCI Clinical Investigator Team Leadership Award (1P30 CA142543-01 supplement; to DEG); NCI Midcareer Investigator Award in Patient-Oriented Research (K24CA201543-01; to DEG); the Cancer Prevention Research Institute of Texas (CPRIT; R1208; to SLP); the Agency for Healthcare Research and Quality (1R24HS022418-01; to EAH, SLP, LX) and the National Center for Advancing Translational Sciences UT Southwestern Center for Translational Medicine (U54 RFA-TR-12-006; to EAH, SLP). We would like to thank Helen Mayo, MLS, from the UT Southwestern Medical Library for assistance performing literature searches. The authors also acknowledge the efforts of the Applied Research Program, NCI; the Office of Research, Development and Information, CMS; Information Management Services (IMS), Inc.; and the Surveillance, Epidemiology, and End Results (SEER) Program tumor registries in the creation of the SEER-Medicare database. Contents of this paper are solely the responsibility of the authors and do not necessarily represent the official view of the NIH. The authors also thank Ms. Dru Gray for assistance with manuscript preparation.

Author contributions

SLP contributed to study design, statistical analysis and manuscript writing. ALL was responsible for literature searches, data interpretation and manuscript writing. LX assisted with study design and manuscript writing and performed all statistical analyses. EAH was involved with study conceptualization, data interpretation, and manuscript writing. DEG was responsible for study conceptualization/design, data interpretation, and manuscipt writing.

Author information

Author notes

    • Sandi L Pruitt
    •  & Andrew L Laccetti

    These authors contributed equally to this work.

Affiliations

  1. Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas, USA

    • Sandi L Pruitt
    • , Lei Xuan
    • , Ethan A Halm
    •  & David E Gerber
  2. Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA

    • Sandi L Pruitt
    • , Ethan A Halm
    •  & David E Gerber
  3. Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA

    • Andrew L Laccetti
    • , Ethan A Halm
    •  & David E Gerber

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Competing interests

The authors declare no conflict of interest.

Corresponding author

Correspondence to David E Gerber.

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