Use of immune checkpoint inhibitor pembrolizumab in the treatment of high-risk, early-stage triple-negative breast cancer: ASCO guideline rapid recommendation update

Use of immune checkpoint inhibitor pembrolizumab in the treatment of high-risk, early-stage triple-negative breast cancer: American Society of Clinical Oncology (ASCO) guideline rapid recommendation update

ASCO Rapid Recommendations Updates highlight revisions to select ASCO guideline recommendations as a response to the emergence of new and practice-changing data. The rapid updates are supported by an evidence review and follow the guideline development processes outlined in the ASCO Guideline Methodology Manual. The goal of these articles is to disseminate updated recommendations, in a timely manner, to better inform health practitioners and the public on the best available cancer care options.

Background: In 2021, ASCO published a guideline on neoadjuvant chemotherapy, endocrine therapy, and targeted therapy for breast cancer. Recently, results of the fourth interim analysis of data from the KEYNOTE-522 randomized (2:1), double-blind, placebo-controlled trial were published. KEYNOTE-522 evaluated the combination of neoadjuvant carboplatin and paclitaxel followed by doxorubicin or epirubicin and cyclophosphamide with pembrolizumab (n = 784) or placebo (n = 390), with completion of one year of pembrolizumab or placebo after surgery, in 1,174 patients with previously untreated, stage II or stage III triple-negative breast cancer (TNBC). Patients were eligible for KEYNOTE-522 regardless of programmed death-ligand 1 expression. Adjuvant capecitabine use was not allowed. The statistically significant event-free survival (EFS) results of KEYNOTE-522 trial constituted a strong signal for an update of the 2021 ASCO guideline recommendation on the role of pembrolizumab in the treatment of high-risk, early-stage TNBC.


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