Surrogate Endpoints in Oncology: Overview of Systematic Reviews and Their Use for Health Decision Making in Mexico.
OBJECTIVES
The use of surrogate endpoints (SEs) for cancer drug approval in health systems is common. The objectives of this study were to identify systematic reviews (SRs) that evaluated the correlation of SEs with overall survival (OS) in cancer drugs to analyze the applications of approved cancer drugs with SEs in Mexico and to apply the validation framework proposed by the Institute for Quality and Efficiency in Health Care (IQWiG).


METHODS
An overview of SRs was conducted according to Cochrane Collaboration methodology. Applications for approved cancer drugs with SEs in Mexico were analyzed. The IQWiG validation framework was applied to evaluate the SEs identified in the overview and in the applications in Mexico.


RESULTS
A total of 85 SRs that assessed 192 SEs for different types of cancer were selected. According to the IQWiG model, only 2.5% of the SEs analyzed in the overview and only one of the applications in Mexico could be used as surrogates for OS because the reliability (methodological quality) of the SRs and the strength of the correlation of SEs with OS was mostly low (92%) and low (correlation coefficient r ≤ 0.7; 50.5%), respectively. Of the total number of cancer drugs approved in Mexico, 19.4% used SEs.


CONCLUSIONS
Most SEs for different types of cancer could not be used as surrogates for OS according to the IQWiG model, and their use for the approval of cancer drugs in Mexico is generally not justified.
['Ortiz|Yesenia|Y|', 'Fareli|Christian J|CJ|', 'Gallegos|Veronica|V|', 'Hernández|Esteban|E|']
D015415:Biomarkers D003657:Decision Making D006801:Humans D008800:Mexico D015203:Reproducibility of Results D000078202:Systematic Reviews as Topic
surrogate endpoints health decision making validation framework antineoplastic agents overview of reviews patient-relevant endpoints