Standardizing Pathologic Evaluation of Breast Carcinoma After Neoadjuvant Chemotherapy Recommendations From the I-SPY Pathology Working Group

center dot Context.-Neoadjuvant systemic therapy refers to the use of systemic agent(s) for malignancy prior to surgical treatment and has recently emerged as an option for most breast cancer patients eligible for adjuvant systemic therapy. Consequently, treated breast carcinomas have become routine specimens in pathology practices. A standard protocol has not yet been universally adopted for the evaluation and reporting of these specimens. The American Joint Committee on Cancer staging system recognizes the challenges in staging breast carcinomas after neoadjuvant treatment and provides important data points but does not currently provide detailed guidance in estimating the residual tumor burden in the breast and lymph nodes. The Residual Cancer Burden system is the only Web-based system that quantifies treatment response as a continuous variable using residual tumor burden in the breast and the lymph nodes. Objective.-To provide clarifications and guidance for evaluation and reporting of postneoadjuvant breast spec-imens, discuss issues with the current staging and reporting systems, and provide specific suggestions for future modifications to the American Joint Committee on Cancer system and the Residual Cancer Burden calculator. Data Sources.-English-language literature on the sub-ject and the data from the I-SPY 2, a multicenter, adaptive randomization phase 2 neoadjuvant platform trial for early-stage, high-risk breast cancer patients. Conclusions.-This article highlights challenges in the pathologic evaluation and reporting of treated breast carcinomas and provides recommendations and clarifica-tions for pathologists and clinicians. It also provides specific recommendations for staging and discusses future directions.