Danae Perry, Bronte Librizzi, Lily Ngu, Michael Ricciardello, Amy Street, Rhonda Clifford, Carmel Goodman, Peter Peeling, Sandra M Salter
Medication information and supply behaviours in elite and developing athletes
Journal of science and medicine in sport
intermediate clinical endpoints ices frequently used primary endpoint randomised trials rcts aim assess whether changes different ices used predict changes overall survival os adjuvant breast cancer trials individual patient level data adjuvant phase iii rcts conducted gruppo italiano mammella gim mammella intergruppo mig study groups used ices computed according steep criteria using twostage metaanalytic model assessed surrogacy ice outcome ie os ice correlated irrespective treatment trial ie treatment effects ice treatment effect os correlated levels following ices considered potential surrogate endpoints os diseasefree survival dfs distant diseasefree survival ddfs distant relapsefree survival drfs recurrencefree survival rfs recurrencefree interval rfi distant recurrencefree interval drfi breast cancerfree interval bcfi invasive breast cancerfree survival ibcfs estimates degree correlation obtained copula models weighted linear regression kendalls r2 070 considered indicators clinically relevant surrogacy among 12397 patients enrolled november 1992 july 2012 six rcts median age enrolment 57 years interquartile range iqr 4965 median followup 103 years iqr 64145 2131 172 os events observed 1390 652 attributed breast cancer outcomelevel kendalls ranged 069 bcfi 084 drfs dfs ddfs drfs rfs rfi drfi bcfi ibcfs endpoints 95 8year os variability attributable variation 5year ice triallevel treatment effects different ices os strongly correlated highest correlation rfs drfs lowest bcfi results provide evidence supporting use dfs ddfs drfs rfs rfi drfi ibcfs primary endpoint breast cancer adjuvant trials analysis supported italian association cancer research associazione italiana per la ricerca sul cancro airc ig 201720760 italian ministry health5 1000 funds years 20212022