A Valid Surrogate Endpoint for Event-Free Survival

January 30, 2019

San Fransisco, CA USA

Is pathological complete response a valid surrogate endpoint for event-free survival in patients with resectable breast cancer?

Buyse M. Invoted lecture at the UCSF Breast Oncology Program Seminar, San Francisco, CA, January 30, 2019.

Abstract: A surrogate endpoint is intended to replace a clinical endpoint for the evaluation of new treatments when it can be measured more conveniently, more frequently, or earlier than that clinical endpoint. A surrogate endpoint is expected to predict clinical benefit, harm, or lack of these. The ICH Guidelines on Statistical Principles for Clinical Trials state that “In practice, the strength of the evidence for surrogacy depends upon (i) the biological plausibility of the relationship, (ii) the demonstration in epidemiological studies of the prognostic value of the surrogate for the clinical outcome, and (iii) evidence from clinical trials that treatment effects on the surrogate correspond to effects on the clinical outcome”. We will assess evidence for surrogacy of pathological complete response after neo-adjuvant treatment of patients with resectable breast cancer.