Since the early days of clinical cancer research, given the expected direct cytotoxicity of chemotherapy, tumor shrinkage has been used as a proxy for anticancer activity. IDDI organized a webinar on the use of endpoints based on tumor measurements in cancer clinical trial.
In this webinar, the speaker provided:
- An overview of the use of endpoints based on tumor measurements in cancer clinical trials.
- The definitions of the traditional and novel response-based endpoints, discussing their pros and cons.
- Several examples, including results of their own work related, in particular, to modeling tumor-size changes and use of the depth of response as a surrogate for overall survival in colorectal cancer trials
ABSTRACT:
Given the expected direct cytotoxicity of chemotherapy, tumor shrinkage has been used as a proxy for anticancer activity since the early days of clinical cancer research. Despite the differing modes of action of some targeted and immunotherapeutic agents, tumor responses are still widely used in oncology, especially for proof-of- concept and phase II trials. For practical purposes, tumor responses are usually dichotomized for analysis, and the response rate is used as one of the indicators of treatment success in clinical trials. Several guidelines for assessment of the response rate have been developed over the years, with the current Response Evaluation Criteria in Solid Tumors (RECIST) being widely used and periodically updated. However, tumor shrinkage can also be analyzed in other ways that capture the relative change from baseline in tumor measurements. Moreover, novel endpoints such as early tumor shrinkage, early objective tumor response, or the depth of response have been suggested as potential surrogates for overall survival in some settings.
SPEAKERS:
