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A comprehensive analysis of clinical trials including both immunotherapy and radiation therapy

  • Original Research
  • Published:
Journal of Radiation Oncology

Abstract

Purpose

Radiation therapy (RT) may work synergistically with cancer immunotherapies but clinical trial data is needed to validate this paradigm. We isolated the portfolio of trials that investigate the primary immunomodulatory properties of RT and examined recent trends in clinical trials that combine immunotherapy and RT (ITRT).

Methods

We queried clinicaltrials.gov for trials initiated since 2002 using both radiation and immunotherapy as mandated interventions. We designated the trials that examine the specific aspects of RT or its abscopal properties as “Primary RT Immunomodulation” trials. Chi-squared analysis determined differences between primary RT immunomodulation trials and those that incorporate RT as a secondary intervention. Joinpoint regression modeling determined the rate of change of the introduction of new trials over time.

Results

One hundred and ninety trials met inclusion criteria. Targeted immunostimulatory agents, including checkpoint inhibitors, were the most common immunotherapy (n = 79 [41.6%]). Sixty-six (34.7%) trials included RT as the primary intervention, with 50 (75.6%) of these utilizing stereotactic body radiation (SBRT). All ITRT trials increased at a rate of 14.8% per year. Primary RT immunomodulation trials increased at a rate of 26.8% per year. Primary RT immunomodulation trials were more likely to utilize targeted immunostimulatory agents (p < 0.01), and SBRT (p < 0.01), and more likely to involve metastatic sites (p < 0.01). The number of ITRT studies increased drastically in the latest two years of the study.

Conclusion

The number of new ITRT clinical trials is increasing rapidly. This increase in quantity may improve the clinical application of the immunomodulatory properties of RT.

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Authors and Affiliations

  1. Department of Radiation Oncology, University of Utah, Salt Lake City, UT, USA

    Dustin Boothe & Shane Lloyd

  2. Penn State College of Medicine, Hershey, PA, USA

    Joseph W. Clyde

  3. School of Medicine, University of Utah, Salt Lake City, UT, USA

    Michael Christensen

  4. Department of Internal Medicine, Division of Medical Oncology, University of Utah, Salt Lake City, UT, USA

    Shiven B. Patel

  5. Department of Radiation Oncology, University of Utah Huntsman Cancer Institute, 1950 Circle of Hope, Rm. 1570, Salt Lake City, UT, 84112, USA

    Shane Lloyd

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  1. Dustin Boothe
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  2. Joseph W. Clyde
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  5. Shane Lloyd
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Correspondence to Shane Lloyd.

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Dustin Boothe, Joseph W. Clyde, Michael Christensen, Shiven Patel, and Shane Lloyd declare that they have no funding to disclose.

Conflict of interest statement

Dustin Boothe, Joseph W. Clyde, Michael Christensen, and Shiven Patel declare that they have no conflict of interest. Shane Lloyd received personal fees from Sirtex outside of the submitted work.

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Dustin Boothe and Joseph Clyde worked equally on this manuscript and are co-first authors.

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Boothe, D., Clyde, J.W., Christensen, M. et al. A comprehensive analysis of clinical trials including both immunotherapy and radiation therapy. J Radiat Oncol 7, 223–232 (2018). https://doi.org/10.1007/s13566-018-0351-x

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