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Comment & Response
October 24, 2019

Tumor Mutation Burden—From Doubts to Concerns

Author Affiliations
  • 1Oregon Health & Science University, Portland
  • 2Division of Hospital and Specialty Medicine, Veterans Administration Portland Healthcare System, Portland, Oregon
JAMA Oncol. Published online October 24, 2019. doi:https://doi.org/10.1001/jamaoncol.2019.4138

To the Editor The role of tumor mutation burden (TMB) in predicting cancer immunotherapy response is predicated on the well-supported hypothesis that the immune system is able to recognize and respond to cancer-specific neoantigens. Even as a bulk and indirect neoantigen surrogate, TMB has been increasingly accepted as a biomarker of response. In their recent Viewpoint, Addeo et al1 compellingly described the adoption of TMB as overzealous “groupthink,” with real-world implications for patients. The implications are broad, with TMB influencing internationally recommended treatment guidelines, US Food and Drug Administration approval, and clinical practice. We also note an expanding cohort of clinical trials (eg, NCT03668119, NCT03178552, NCT03519412) that are actively using TMB status as an inclusion criterion.

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