Pathological Complete Response Predicts Event-Free and Distant Disease Free Survival in the I-SPY 2 TRIAL

Presentation from the 2017 San Antonio Breast Cancer Symposium by Douglas Yee, MD Masonic Cancer Center, University of Minnesota

Pathological complete response (pCR) is a strong predictor of event-free survival (EFS) and distant recurrence- free survival (DRFS) in the setting of a multiple agent platform trial that includes:

  • Standards for eligibility: high risk for early recurrence (MP low risk, HR+Her2- excluded), exclusion of metastatic disease
  • All chemotherapy given before pCR determination
  • Standards for pathology assessment and multidisciplinary identification (surgeons, radiologists, pathologists)
  • Long term follow-up of patients over time (correlation of early, intermediate, and late endpoints)

pCR is equally predictive across all tumor subsets, and as an endpoint enables rapid evaluation of novel therapy