New Guidelines to Evaluate the Response to Treatment in Solid Tumors

TLDR

Tumor response evaluation criteria were first codified in the late 1970s by the International Union Against Cancer and the World Health Organization, and anticancer cytotoxic agents have been studied based on the tumor shrinkage they can produce. The article aims to clarify the purposes of response evaluation and proposes a model that combines target and nontarget lesions to derive an overall treatment response. The authors reviewed existing criteria, developed a unidimensional measurement model for response rates, codified lesion assessment methods, and introduced a combined lesion model to extrapolate overall response. The new guidelines, which replace the former criteria, have been validated by the Response Evaluation Criteria in Solid Tumors Group and incorporated into the present recommendations.

Abstract

Anticancer cytotoxic agents go through a process by which their antitumor activity-on the basis of the amount of tumor shrinkage they could generate-has been investigated. In the late 1970s, the International Union Against Cancer and the World Health Organization introduced specific criteria for the codification of tumor response evaluation. In 1994, several organizations involved in clinical research combined forces to tackle the review of these criteria on the basis of the experience and knowledge acquired since then. After several years of intensive discussions, a new set of guidelines is ready that will supersede the former criteria. In parallel to this initiative, one of the participating groups developed a model by which response rates could be derived from unidimensional measurement of tumor lesions instead of the usual bidimensional approach. This new concept has been largely validated by the Response Evaluation Criteria in Solid Tumors Group and integrated into the present guidelines. This special article also provides some philosophic background to clarify the various purposes of response evaluation. It proposes a model by which a combined assessment of all existing lesions, characterized by target lesions (to be measured) and nontarget lesions, is used to extrapolate an overall response to treatment. Methods of assessing tumor lesions are better codified, briefly within the guidelines and in more detail in Appendix I. All other aspects of response evaluation have been discussed, reviewed, and amended whenever appropriate.