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Selection of Patients in Ongoing Clinical Trials on Lung Cancer

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Abstract

Background

Lung cancer is predominantly a disease of the elderly: half of all newly diagnosed patients are over 70 years old. Older patients and those with comorbidities are underrepresented in clinical trials; scientific communities have addressed this issue since the end of the 20th century. We set out to determine the characteristics of the selection of patients in lung cancer trials that are currently recruiting.

Methods

We searched The United States National Institutes of Health (NIH) clinical trial registry (www.clinicaltrials.gov) on April 23, 2015 for currently recruiting phase I, II, or III clinical trials in lung cancer. Trial characteristics and study objectives were extracted from the registry website.

Results

Of the 419 trails selected in this overview, 88 % explicitly or implicitly excluded elderly patients. Patients were excluded based on stringent organ selection in 76 % of the trials, based on performance status (57 %) and based on age (13 %). The median number of placed restrictions per trial was seven. In the 2 % of the trials that were exclusively designed for elderly patients only fit patients were included.

Conclusion

In this overview of current lung cancer trials registered in the NIH clinical trial registry, we found that elderly patients and those with comorbidities are often excluded from participation in clinical trials. Therefore, it is difficult for physicians and their frail patients to properly evaluate the efficacy and safety of current treatment options. More research that includes the elderly and those with comorbidities is urgently needed.

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Abbreviations

NIH:

National Institutes of Health

NSCLC:

Non-small cell lung cancer

PS:

Performance status

SCLC:

Small cell lung cancer

WHO:

World Health Organization

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Acknowledgment

This study was supported by the Aart Huisman Scholarship for research in geriatric oncology and the Cornelis Visser Foundation.

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Authors and Affiliations

  1. Department of Internal Medicine, Diakonessenhuis Utrecht, Bosboomstraat 1, 3582 KE, Utrecht, The Netherlands

    Karlijn J.G. Schulkes & Cindy Nguyen

  2. Department of Internal Medicine, Haga Hospital, Leyweg 275, 2545 CH, The Hague, The Netherlands

    Frederiek van den Bos

  3. Department of Pulmonology, Diakonessenhuis Utrecht, Utrecht, The Netherlands

    Leontine J.R. van Elden

  4. Department of Geriatric Medicine, Diakonessenhuis Utrecht, Utrecht, The Netherlands

    Marije E. Hamaker

Authors
  1. Karlijn J.G. Schulkes
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  2. Cindy Nguyen
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  3. Frederiek van den Bos
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  4. Leontine J.R. van Elden
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  5. Marije E. Hamaker
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Corresponding author

Correspondence to Karlijn J.G. Schulkes.

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No potential conflicts of interest.

Appendix

Appendix

See Table 3.

Table 3 Classification of inclusion and exclusion criteria for organ function
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Schulkes, K.J., Nguyen, C., van den Bos, F. et al. Selection of Patients in Ongoing Clinical Trials on Lung Cancer. Lung 194, 967–974 (2016). https://doi.org/10.1007/s00408-016-9943-7

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  • DOI: https://doi.org/10.1007/s00408-016-9943-7

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