A study shows that some intermediate clinical endpoints (ICE) can effectively predict changes in overall survival (OS) in early-stage patients receiving adjuvant therapy. This finding challenges the traditional belief that OS is the primary endpoint and suggests that ICE can be considered surrogate endpoints for OS in this population.
show that some of the so-called intermediate clinical endpoints can predict changes in overall survival in patients with early-stagewho are receiving adjuvant therapy . Therefore, these ICE can effectively be considered surrogate endpoints for OS in this population, according to Eva Blondeaux, MD, of the epidemiology unit at IRCCS Ospedale Policlinico San Martino in Genoa, Italy, and colleagues.
"This is a nonobvious conclusion," Lorenzo Gerratana, MD, of the Department of Medicine at the University of Udine and the Department of Medical Oncology at IRCCS CRO in Aviano, Italy."OS represents the primary endpoint par excellence, but we also have intermediate endpoints available. Blondeaux and colleagues' work aimed precisely to verify if these intermediate endpoints are also surrogates of OS, a condition that does not always occur," he said.
Outcome analyses showed that more than 95% of the variability in OS observed at 5 years was attributable to the 5-year variation in ICE. The ICE evaluated and identified as surrogates are disease-free survival , distant DFS, recurrence-free survival , distant RFS, recurrence-free interval , distant RFI, breast cancer-free interval , and invasive breast cancer-free survival. At the trial level, ICE and OS were found to be correlated.
Gerratana also pointed out that today, in addition to treatment, the risk classification methods have changed significantly: The stage remains one of the most important parameters, but many others have been added, such as genomic analyses that guide adjuvant choice. "From a certain point of view, this is undoubtedly a seminal study that tells us that, based on the data and treatments done in the past 30 years, there is a form of surrogacy. And this result is far from obvious," said Gerratana."Now there is a need to refine the data, especially considering the new types of treatment and risk classifications, for which it would be interesting to have specific and updated data.
Intermediate Clinical Endpoints Overall Survival Early-Stage Patients Adjuvant Therapy Surrogate Endpoints
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