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Cancer Immunology Research

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Phase II Trial of Ipilimumab with Stereotactic Radiation Therapy for Metastatic Disease: Outcomes, Toxicities, and Low-Dose Radiation–Related Abscopal Responses

James W. Welsh, Chad Tang, Patricia de Groot, Aung Naing, Kenneth R. Hess, John V. Heymach, Vassiliki A. Papadimitrakopoulou, Taylor R. Cushman, Vivek Subbiah, Joe Y. Chang, George R. Simon, Rishab Ramapriyan, Hampartsoum B. Barsoumian, Hari Menon, Maria Angelica Cortez, Erminia Massarelli, Quynh Nguyen, Padmanee Sharma, James P. Allison, Adi Diab, Vivek Verma, Uma Raju, Sherif G. Shaaban, Ramona Dadu, Maria E. Cabanillas, Kelvin Wang, Clark Anderson, Daniel R. Gomez, Stephen Hahn, Ritsuko Komaki and David S. Hong
James W. Welsh
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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  • For correspondence: jwelsh@mdanderson.org
Chad Tang
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Patricia de Groot
Department of Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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  • ORCID record for Patricia de Groot
Aung Naing
Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Kenneth R. Hess
Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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John V. Heymach
Department of Thoracic and Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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  • ORCID record for John V. Heymach
Vassiliki A. Papadimitrakopoulou
Department of Thoracic and Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Taylor R. Cushman
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Vivek Subbiah
Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Joe Y. Chang
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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George R. Simon
Department of Thoracic and Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Rishab Ramapriyan
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Hampartsoum B. Barsoumian
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Hari Menon
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Maria Angelica Cortez
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Erminia Massarelli
Department of Thoracic and Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Quynh Nguyen
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Padmanee Sharma
Department of Genitouirinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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James P. Allison
Department of Immunology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Adi Diab
Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Vivek Verma
Department of Radiation Oncology, Allegheny General Hospital, Pittsburgh, Pennsylvania.
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Uma Raju
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Sherif G. Shaaban
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Ramona Dadu
Department of Endocrine Neoplasia and Hormonal Disorders, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Maria E. Cabanillas
Department of Endocrine Neoplasia and Hormonal Disorders, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Kelvin Wang
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Clark Anderson
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Daniel R. Gomez
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Stephen Hahn
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Ritsuko Komaki
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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David S. Hong
Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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  • ORCID record for David S. Hong
DOI: 10.1158/2326-6066.CIR-18-0793 Published December 2019
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Abstract

Ipilimumab is effective for patients with melanoma, but not for those with less immunogenic tumors. We report a phase II trial of ipilimumab with concurrent or sequential stereotactic ablative radiotherapy to metastatic lesions in the liver or lung (NCT02239900). Ipilimumab (every 3 weeks for 4 doses) was given with radiotherapy begun during the first dose (concurrent) or 1 week after the second dose (sequential) and delivered as 50 Gy in 4 fractions or 60 Gy in 10 fractions to metastatic liver or lung lesions. In total, 106 patients received ≥1 cycle of ipilimumab with radiation. Median follow-up was 10.5 months. Median progression-free survival time was 2.9 months (95% confidence interval, 2.45–3.40), and median overall survival time was not reached. Rates of clinical benefit of nonirradiated tumor volume were 26% overall, 28% for sequential versus 20% for concurrent therapy (P = 0.250), and 31% for lung versus 14% for liver metastases (P = 0.061). The sequential lung group had the highest rate of clinical benefit at 42%. There were no differences in treatment-related adverse events between groups. Exploratory analysis of nontargeted lesions revealed that lesions receiving low-dose radiation were more likely to respond than those that received no radiation (31% vs. 5%, P = 0.0091). This phase II trial of ipilimumab with stereotactic radiotherapy describes satisfactory outcomes and low toxicities, lending support to further investigation of combined-modality therapy for metastatic cancers.

Footnotes

  • Note: Supplementary data for this article are available at Cancer Immunology Research Online (http://cancerimmunolres.aacrjournals.org/).

  • Cancer Immunol Res 2019;7:1903–9

  • ↵†Deceased.

  • Received November 4, 2018.
  • Revision received March 11, 2019.
  • Accepted October 21, 2019.
  • Published first October 28, 2019.
  • ©2019 American Association for Cancer Research.
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Cancer Immunology Research: 7 (12)
December 2019
Volume 7, Issue 12
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Phase II Trial of Ipilimumab with Stereotactic Radiation Therapy for Metastatic Disease: Outcomes, Toxicities, and Low-Dose Radiation–Related Abscopal Responses
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Phase II Trial of Ipilimumab with Stereotactic Radiation Therapy for Metastatic Disease: Outcomes, Toxicities, and Low-Dose Radiation–Related Abscopal Responses
James W. Welsh, Chad Tang, Patricia de Groot, Aung Naing, Kenneth R. Hess, John V. Heymach, Vassiliki A. Papadimitrakopoulou, Taylor R. Cushman, Vivek Subbiah, Joe Y. Chang, George R. Simon, Rishab Ramapriyan, Hampartsoum B. Barsoumian, Hari Menon, Maria Angelica Cortez, Erminia Massarelli, Quynh Nguyen, Padmanee Sharma, James P. Allison, Adi Diab, Vivek Verma, Uma Raju, Sherif G. Shaaban, Ramona Dadu, Maria E. Cabanillas, Kelvin Wang, Clark Anderson, Daniel R. Gomez, Stephen Hahn, Ritsuko Komaki and David S. Hong
Cancer Immunol Res December 1 2019 (7) (12) 1903-1909; DOI: 10.1158/2326-6066.CIR-18-0793

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Phase II Trial of Ipilimumab with Stereotactic Radiation Therapy for Metastatic Disease: Outcomes, Toxicities, and Low-Dose Radiation–Related Abscopal Responses
James W. Welsh, Chad Tang, Patricia de Groot, Aung Naing, Kenneth R. Hess, John V. Heymach, Vassiliki A. Papadimitrakopoulou, Taylor R. Cushman, Vivek Subbiah, Joe Y. Chang, George R. Simon, Rishab Ramapriyan, Hampartsoum B. Barsoumian, Hari Menon, Maria Angelica Cortez, Erminia Massarelli, Quynh Nguyen, Padmanee Sharma, James P. Allison, Adi Diab, Vivek Verma, Uma Raju, Sherif G. Shaaban, Ramona Dadu, Maria E. Cabanillas, Kelvin Wang, Clark Anderson, Daniel R. Gomez, Stephen Hahn, Ritsuko Komaki and David S. Hong
Cancer Immunol Res December 1 2019 (7) (12) 1903-1909; DOI: 10.1158/2326-6066.CIR-18-0793
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