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Selection of Response Criteria for Clinical Trials of Sarcoma Treatment

^aDepartment of Internal Medicine, Division of Hematology/Oncology, University of Michigan, Ann Arbor, Michigan, USA; ^bDepartment of Sarcoma Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston, Texas, USA; ^cBristol-Myers Squibb, Wallingford, Connecticut, USA

Key Words. Sarcoma • Clinical trials • Response • Imaging

Correspondence: Scott Schuetze, M.D., Ph.D., Department of Internal Medicine, Division of Hematology/Oncology, 1500 E. Medical Center Drive, C409 MIB, Ann Arbor, Michigan 48109-5843, USA. Telephone: 734-936-0453; Fax: 734-747-8792; e-mail: scotschu{at}umich

Disclosure: R.B. has acted as a consultant to Novartis. R.C. is an employee of Bristol-Myers Squibb and owns stock in Bristol-Myers Squibb and Zimmer. S.S. has acted as a consultant to Sanofi-Aventis. No other potential conflicts of interest were reported by the authors, planners, reviewers, or staff managers of this article.

Soft tissue sarcomas are a heterogeneous group of malignancies arising from mesenchymal tissues. A large number of new therapies are being evaluated in patients with sarcomas, and consensus criteria defining treatment responses are essential for comparison of results from studies completed by different research groups. The 1979 World Health Organization (WHO) handbook set forth operationally defined criteria for response evaluation in solid tumors that were updated in 2000 with the publication of the Response Evaluation Criteria in Solid Tumors (RECIST). There have been significant advances in tumor imaging, however, that are not reflected in the RECIST. For example, computed tomography (CT) slice thickness has been reduced from 10 mm to 2.5 mm, allowing for more reproducible and accurate measurement of smaller lesions. Combination of imaging techniques, such as positron emission tomography with fluorine-18-fluorodeoxyglucose (¹⁸FDG-PET) and CT can provide investigators and clinicians with both anatomical and functional information regarding tumors, and there is now a large body of evidence demonstrating the effectiveness of PET/CT and other newer imaging methods for the detection and staging of tumors as well as early determination of responses to therapy. The application of newer imaging methods has the potential to decrease both the sample sizes required for, and duration of, clinical trials by providing an early indication of therapeutic response that is well correlated with clinical outcomes, such as time to tumor progression or overall survival. The results summarized in this review support the conclusion that the RECIST and the WHO criteria for evaluation of response in solid tumors need to be modernized. In addition, there is a current need for prospective trials to compare new response criteria with established endpoints and to validate imaging-based response rates as surrogate endpoints for clinical trials of new agents for sarcoma and other solid tumors.