Will There Be Resistance to the RECIST (Response Evaluation Criteria in Solid Tumors)?

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From the earliest days of the Cancer Chemotherapy Cooperative Group Clinical Trials program in the 1950s, there have been concerns about the definition of response in solid tumors and the reliance on quantitative measurements. In the first clinical trial in solid tumors published by Zubrod et al. (1), “Treatment was considered to give a positive response if either the total measured tumor mass decreased, with no lesions increasing in size and no new lesions appearing . . . or the group of voting physicians considered that the treatment had been of benefit to the patient as a whole. . . . .” On the initiative of the World Health Organization (WHO) and following two meetings on the standardization of reporting results of cancer treatment in 1977 and 1979, Miller et al. (2) proposed uniform criteria for reporting response, recurrence, and disease-free interval and the grading of acute and subacute toxicity. These criteria have received wide acceptance and have become known as the WHO criteria in reporting the results of cancer treatment. In 1992, the Southwest Oncology Group (SWOG), in cooperation with the National Cancer Institute and other major cooperative oncology groups, participated in meetings to develop new toxicity criteria, end point definitions, and response criteria. A set of new guidelines was proposed because of “uncertainties in clinical trials objectives, limitations in the resolution of imaging methods, and demands for greater rigor in response and endpoint definitions” (3).