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Response as a Measure of Treatment Efficacy in Clinical Trials: Should RECIST Be Abandoned?

  • Michael Friedlander
  • James Tate Thigpen
Chapter

Abstract

Demonstration of the efficacy and tolerability of new approaches to the treatment of ovarian cancer depends on clinical trials that are well designed with endpoints that are reproducibly and reliably assessable, that reflect clinical benefit, and that lead to the definition of a role, or lack thereof, for that treatment in ovarian cancer. Endpoints for current clinical trials are generally drawn from three options: objective response, progression-free survival, and overall survival. For objective response, current assessments are based on the RECIST criteria. These criteria were the product of an attempt to clarify response criteria and to improve accuracy in the process of measurement. Suggestions that RECIST should be abandoned point to several specific perceived problems: excessive complexity, arbitrariness of definitions for response and progression, lack of usefulness in patients without measurable disease, questions regarding the reliability of RECIST criteria for assessing response particularly in regard to the incorporation of CA-125 as a response criterion, the lack of applicability of RECIST criteria to the assessment of efficacy of many of the new targeted agents, and the difficulty of defining what constitutes clinical benefit. Examination of these criticisms leads to the conclusion that, while there are circumstances in which the RECIST criteria are not applicable to a particular study, the criteria provide useful information in a reliable if somewhat complex way and are no more arbitrary than other endpoints. The clear answer to the question as to whether RECIST should be abandoned is absolutely no. RECIST should be used in those studies for which it is appropriate. On the other hand, efforts to improve further on the RECIST criteria and to go beyond the criteria to incorporate new findings such as molecular markers into endpoints are imperative if studies are to keep pace with the explosion of biologic knowledge.

Keywords

Ovarian Cancer Target Lesion Measurable Disease RECIST Criterion Pegylated Liposomal Doxorubicin 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer-Verlag London 2014

Authors and Affiliations

  1. 1.Department of Medical OncologyThe Prince of Wales HospitalRandwick, SydneyAustralia
  2. 2.Medicine: Oncology-HematologyUniversity of Mississippi Medical CenterJacksonUSA

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