Unpacking the New Recommendations for Early-Stage Breast Cancer Management

In season 3, episode 3 of Targeted Talks, William J. Gradishar, MD, discusses the latest version of the NCCN Clinical Practice Guideline for managing early-stage breast cancer.

In season 3, episode 3 of Targeted Talks, William J. Gradishar, MD, chief of Hematology and Oncology in the Department of Medicine, Betsy Bramsen professor of Breast Oncology, and professor of Medicine (Hematology and Oncology) at Northwestern Medicine, Feinberg School of Medicine, discusses the latest version of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for managing early-stage breast cancer.

Patients with early-stage breast cancer have more options than ever before, but the biggest recent updates have been for patients with estrogen receptor-positive disease, says Gradishar. This is a patient population with a high risk of recurrence, and 2 new therapies with different mechanisms of action have demonstrated the ability to reduce the risk of recurrence.

First, based on the phase monarchE clinical trial (NCT03155997), the FDA granted approval to abemaciclib (Verzenio), in combination with endocrine therapy, for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of ≥20% in October of 2021. The study showed that CDK4/6 inhibition is effective for this patient subgroup, according to Gradishar.

For the subgroup of patients with BRCA-mutated tumors, the recent FDA approval of olaparib (Lynparza) for the adjuvant treatment for patients with BRCA-mutated HER2-negative high-risk early breast cancer that were previously treated with chemotherapy before or after surgery is another important update to the NCCN guideline. Approval of the PARP inhibitor was supported by findings from the phase 3 OlympiA trial (NCT02032823).


Looking ahead, Gradishar still sees room for improving early-stage breast cancer management. Ongoing drug development may offer more promising options for select subgroups in the near future.