MIAMI BEACH – The Food and Drug Administration has accepted pathological complete response rate (pCR) as a surrogate endpoint for disease-free and overall survival in clinical trials for neoadjuvant therapy of breast cancer.
Yet the specimen collection and histopathologic methods used to measure pCR have differed considerably across major neoadjuvant trials for breast cancer, said Michael F. Press, MD, PhD, of the USC/Norris Comprehensive Cancer Center at the University of California, Los Angeles.
In a video interview conducted at the annual Miami Breast Cancer Conference, held by Physicians’ Education Resource, Dr. Press outlined the problems associated with a lack of standardization of outcomes measures, and described how residual cancer burden may be a more effective, validated measures for comparing outcomes across clinical trials.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel.
Dr. Press disclosed grant/research support from Cepheid, and consulting with Cepheid, Karyopharm Therapeutics, Eli Lilly, Puma Biotechnology, Halozyme Therapeutics, Biocartis SA, and ADC Therapeutics.