Influence of Non-Measurable Disease on Progression-Free Survival in Patients with Metastatic Breast Cancer

Despite its lack of established surrogacy with overall survival (OS), progression-free survival (PFS) has become the dominant primary endpoint in phase III randomized controlled trials (RCTs) in metastatic breast cancer, including trials which support drug approval [1–2]. Possible explanations for the poor performance of PFS as a surrogate for OS include trial and patient-related characteristics such as cross-over and both the duration of survival and exposure to treatment post-progression [2]. Additionally, an advantage of the use of PFS as a primary endpoint includes a smaller sample size requirement and shorter duration of follow-up compared to OS.

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