Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria.

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
Jedd D WolchokF Stephen Hodi

Abstract

Immunotherapeutic agents produce antitumor effects by inducing cancer-specific immune responses or by modifying native immune processes. Resulting clinical response patterns extend beyond those of cytotoxic agents and can manifest after an initial increase in tumor burden or the appearance of new lesions (progressive disease). Response Evaluation Criteria in Solid Tumors or WHO criteria, designed to detect early effects of cytotoxic agents, may not provide a complete assessment of immunotherapeutic agents. Novel criteria for the evaluation of antitumor responses with immunotherapeutic agents are required. The phase II clinical trial program with ipilimumab, an antibody that blocks CTL antigen-4, represents the most comprehensive data set available to date for an immunotherapeutic agent. Novel immune therapy response criteria proposed, based on the shared experience from community workshops and several investigators, were evaluated using data from ipilimumab phase II clinical trials in patients with advanced melanoma. Ipilimumab monotherapy resulted in four distinct response patterns: (a) shrinkage in baseline lesions, without new lesions; (b) durable stable disease (in some patients followed by a slow, steady decline in total t...Continue Reading

Associated Clinical Trials

Oct 14, 2015·Oscar Gerardo Arrieta Rodríguez, Oscar Gerardo Arrieta Rodríguez
Nov 6, 2017·Li Zhang, MDLi Zhang, MD

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