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Incidence of immune-related adverse events and its association with treatment outcomes: the MD Anderson Cancer Center experience

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Summary

Background Immunotherapy is emerging as the cornerstone for treatment of patients with advanced cancer, but significant toxicity (immune-related adverse events [irAEs]) associated with unbridled T cell activity remains a concern. Patients and methods A retrospective review of the electronic medical records of 290 patients with advanced cancer treated on an immunotherapy-based clinical trial in the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center between February 2010 and September 2015 was performed. Clinical and laboratory parameters were collected to determine the incidence of irAEs, risk factors, and their association with treatment outcomes. Results Ninety eight of 290 patients (34%) experienced any grade irAEs. Among the 15 (5.2%) patients with grade ≥ 3 irAEs, the most common irAEs were dermatitis and enterocolitis. Although 80% of the patients with grade ≥ 3 irAEs required systemic corticosteroids, all the 15 patients recovered from the irAEs. On re-challenge, 4 of the 5 patients who had received systemic corticosteroids for irAE continued to respond. There were no irAE-related deaths. Importantly, patients with grade ≥ 3 irAEs had improved overall response rate (25 vs. 6%; p = 0.039) and longer median time to progression (30 weeks vs. 10 weeks; p = 0.0040) when compared to those without grade ≥ 3 irAEs. Conclusion Incidence of irAEs with immunotherapeutic agents indicates an active immune status, suggestive of potential clinical benefit to the patient. Further validation of this association in a large prospective study is warranted.

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Funding

This work was supported in part by The University of Texas MD Anderson Cancer Center support grant (P30 CA016672, FM-B, KRH) and a K23 Career Development Award (K23 AI117024; AS) from the National Institute of Health.

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Authors and Affiliations

  1. Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX, 77030, USA

    Takeo Fujii, Mehmet Asim Bilen, Anas Alshawa, David S. Hong, Apostolia Tsimberidou, Filip Janku, **g Gong, Bettzy Stephen, Vivek Subbiah, Sarina A. Piha-Paul, Siqing Fu, Funda Meric-Bernstam & Aung Naing

  2. Department of Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Rivka R. Colen

  3. Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Kenneth R. Hess

  4. Department of Immunology, Allergy, and Rheumatology, Baylor College of Medicine, Houston, TX, USA

    Joud Hajjar

  5. Department of General Internal Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Maria E. Suarez-Almazor

  6. Department of Immunology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Padmanee Sharma

  7. Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Tito Mendoza

  8. Department of Dermatology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Anisha Patel

  9. Department of Gastroenterology Hepatology & Nutrition, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Selvi Thirumurthi

  10. Department of Pulmonary Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Ajay Sheshadri

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  1. Takeo Fujii
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TF contributed to study design, collected and assembled the data, and was a major contributor in writing the manuscript; RRC contributed to data analysis and interpretation; MAB collected and assembled the data; KRH contributed to study design, performed statistical analysis, and contributed to interpretation of results; JH, MES-A, JG, PS, TM, AP, ST, AS contributed to interpretation of results; AA collected and assembled the data; DSH, AT, FJ, VS, SAP-P, SF, FM-B contributed to patient enrollment, assembly and interpretation of data; BS contributed to data analysis, interpretation, and was a major contributor in writing the manuscript; AN designed the study, provided administrative support, contributed to patient enrollment, assembly and interpretation of data and was a major contributor in writing the manuscript. All authors read and approved the final manuscript.

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Correspondence to Aung Naing.

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The authors declare no competing financial interests.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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For this type of study formal consent is not required.

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Fujii, T., Colen, R.R., Bilen, M.A. et al. Incidence of immune-related adverse events and its association with treatment outcomes: the MD Anderson Cancer Center experience. Invest New Drugs 36, 638–646 (2018). https://doi.org/10.1007/s10637-017-0534-0

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  • DOI: https://doi.org/10.1007/s10637-017-0534-0

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