Neoadjuvant therapy

Resection of the bulk of the tumor and tumor-infiltrating lymphocytes may decrease the potential effect of programmed death-1 (PD-1) blockade in the adjuvant setting, leading investigators to study the use of neoadjuvant immunotherapy. Neoadjuvant pembrolizumab can be considered for patients with high-risk, node-positive disease or resectable metastatic disease. This treatment approach is based on the results of a randomized phase II trial in which 1 year of neoadjuvant and adjuvant pembrolizumab resulted in an improvement in event-free survival (EFS) compared with primary resection plus adjuvant pembrolizumab. The U.S. Food and Drug Administration (FDA) has not approved this regimen, pending the completion of a randomized phase III trial.