Background Surrogates are frequently used in cancer medicine as the end-point of clinical
trials and as the basis of United States Food and Drug Administration approvals, but they do …

Importance The strength of association between surrogate end points and survival in
oncology is important to understand because surrogate end points are frequently used in …

Direct evidence comes from research that directly compares the interventions in which we
are interested when applied to the populations in which we are interested and measures …

Objective To assess the efficacy and safety of pyrotinib (an irreversible pan-HER (human
epidermal growth factor receptor) inhibitor), trastuzumab, and docetaxel compared with …

A distinctive subset of metastatic breast cancer (MBC) is oligometastatic disease, which is
characterized by single or few detectable metastatic lesions. The existing treatment …

No gold standard treatment exists for metastatic breast cancer (MBC). Clinical decision
making is based on knowledge of prognostic and predictive factors that are extrapolated …

Abstract Background In July 2018, the FDA first published a table listing all surrogate
measures that it has used, and may accept for future use, in regulatory approval. However …

Background Cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors+ endocrine therapy (ET)
prolonged progression-free survival as first-or second-line therapy for hormone receptor …

Purpose: With the approval of immunotherapies for a variety of indications, methods to
assess treatment benefit addressing the response patterns observed are important. We …

Introduction Cancer immunotherapy may alter tumor biology such that treatment effects can
extend beyond radiographic progression. In the randomized, phase III OAK study of …