Guidelines for the Evaluation of Immune Therapy Activity in Solid Tumors: Immune-Related Response Criteria

As we further investigate the clinical utility of immune-related response criteria, they may need to be further optimized

J. D. Wolchok

2009

Scholarcy highlights

  • Immunotherapeutic agents produce antitumor effects by inducing cancerspecific immune responses or by modifying native immune processes
  • Workshops to discuss their experience with immunotherapeutic agents in cancer patients. These discussions resulted in the following conclusions: The appearance of measurable antitumor activity may take longer for immune therapies than for cytotoxic therapies; responses to immune therapies may occur after conventional progressive disease; discontinuation of immune therapy may not be appropriate in some cases, unless PD is confirmed; allowance for “clinically insignificant” PD is recommended; and durable SD may represent antitumor activity
  • Some patients characterized as PD at week 12, either by an increase in tumor burden and/or the appearance of new lesions, subsequently experienced an objective response or SD without the addition of non-ipilimumab anticancer therapy
  • Two of the response patterns are captured with conventional response criteria: response in baseline lesions-evident by week 12, with no new lesions, and “stable disease”
  • The core novelty of the immune-related response criteria is the incorporation of measurable new lesions into “total tumor burden” and comparison of this variable to baseline measurements
  • At least 25% increase in tumor burden compared with nadir in two consecutive observations at least 4 wk apart cutaneous lesions and 10 visceral lesions) are added together to provide the total tumor burden: Tumor Burden = SPDindex lesions + SPDnew, measurable lesions
  • In a case study of an ipilimumab-treated patient that seemed to have PD at the 12-week tumor assessment, histologic analyses showed that the increase in lesion size was likely due to T-cell infiltration rather than tumor cell proliferation
  • The immune-related response criteria were defined based on data from ipilimumab clinical trials, but their conceptual foundations result from consistent observations with several agents across the immune therapy community, and it is expected that these criteria will have broad applicability to immunotherapeutic agents

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