Controversies in design and interpretation of adjuvant clinical trials

Cancer Investigation
Jack Cuzick

Abstract

Although aromatase inhibitors are widely used as adjuvant endocrine treatment for hormone-sensitive early breast cancer, the optimal treatment strategy is controversial. Differences in trial design, endpoint definitions, and patient populations preclude straightforward trial comparisons. Standardized, consistent endpoint definitions, focused on efficacy outcomes (e.g., time to recurrence, time to distant recurrence), would allow for more meaningful comparisons. Disease-free survival and overall survival should be secondary endpoints, since they include deaths without recurrence, which can dilute and confuse efficacy evaluations. Distant metastasis is an excellent surrogate for breast cancer death and is available a few years earlier. These changes should lead to more rapid and reliable introduction of improved therapeutic strategies.

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Citations

Oct 14, 2014·The British Journal of Surgery·M MoossdorffM L Smidt

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