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iRECIST: A clarification of tumour response assessment in the immunotherapy era

  • Charles Ferté
    Correspondence
    Corresponding author: Early Drug Development Unit (DITEP), Gustave Roussy, Paris Saclay University, Villejuif, France.
    Affiliations
    Early Drug Development Unit (DITEP), Gustave Roussy, Paris Saclay University, Villejuif, France
    Head and neck cancer department, Gustave Roussy, Paris Saclay University, Villejuif, France
    INSERM U1030, Gustave Roussy, Paris Saclay University, Villejuif, France
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  • Aurélien Marabelle
    Affiliations
    Early Drug Development Unit (DITEP), Gustave Roussy, Paris Saclay University, Villejuif, France
    INSERM U1015, Gustave Roussy, Paris Saclay University, Villejuif, France
    Search for articles by this author
Published:April 04, 2017DOI:https://doi.org/10.1016/j.ejca.2017.02.015
      The advent of immuno-oncology (IO) drugs profoundly changes our understanding of cancer biology as well as the management of patients at bedside. This is especially true for melanoma, renal cell carcinoma, non-small cell lung cancer, head and neck squamous cell carcinoma, Hodgkin's lymphoma or bladder cancer, for which these drugs already demonstrated substantial improvements in the patients' outcome. Beyond these indications, objective tumour responses have been reported in more than 20 different cancer types in early phase trials. The common feature across cancer types is the durability of tumour responses, and the high level of disease control rate which, together, contribute to benefits in patients' outcome such as overall survival as opposed to conventional second line cancer therapies. These features are fuelling-up the development of IO combinations exploring the value of dual immune checkpoint targeting, or approaches revisiting the immune effects of conventional cytotoxics or targeted therapies such as Mitogen-activated Protein Kinase Kinase (MEK) or vascular endothelial growth factor inhibitors. As a result, there is an unprecedented number of trials testing IO agents, vaccines or oncolytic viruses currently registered in the ClinicalTrials.gov database (n = 2833 open studies, February 2017 search).
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