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Trends in the Risks and Benefits to Patients With Cancer in Phase 1 Clinical Trials—Reply
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In Reply: The question raised by Dr Ross regarding stable disease rates as a surrogate for clinical benefit is a valid one: anticancer agents with mechanisms of action that are not cytotoxic may produce clinical benefit by delaying tumor progression without effectively shrinking tumors. For these agents, stable disease rates or time to tumor progression (TTP) may represent more appropriate surrogates for clinical benefit than rates of objective response such as tumor shrinkage. However, stable disease and TTP can be reliably evaluated only with randomized trials. The measure of these end points may be influenced by the underlying biology of the tumor, the frequency of imaging studies, and potential investigator bias in the timing of imaging studies, as well as the interpretation of clinical data. A slow-growing tumor may appear to be of stable size for several months in a phase 1 trial; without concurrent controls it is impossible to . . . [Full Text of this Article]
Thomas G. Roberts, Jr, MD, MSocSci
thomas_roberts1@dfci.harvard.edu
Bernardo H. Goulart, MD;
Jeffrey W. Clark, MD;
Bruce A. Chabner, MD
Massachusetts General Hospital Cancer Center
Boston
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