乳腺癌术后疗效终点标准化定义更新( 三 )

KEY OBJECTIVE: Given the evolution of breast cancer clinical trials and improvements in outcomes, are modifications to the STEEP criteria needed?
KNOWLEDGE GENERATED: An additional endpoint, invasive breast cancer-free survival, which includes all invasive disease-free survival events except second nonbreast primary cancers, can be considered for trials in which the toxicities are well known and where risk of second primary cancer is small. Additional end points for local therapy trials, low-risk populations, noninferiority trials, and trials incorporating patient-reported outcomes are also included.
【乳腺癌术后疗效终点标准化定义更新】RELEVANCE: The choice of a primary end point is critical for detecting a treatment effect and including events that have similar rates in the treatment groups may dilute treatment differences and can increase the likelihood of a false inference of noninferiority.
DOI: 10.1200/JCO.20.03613

本文插图

本文插图

本文插图

本文插图

本文插图

本文插图

本文插图

本文插图

本文插图

本文插图

本文插图

本文插图

本文插图