Add like
Add dislike
Add to saved papers

Overall Survival with Pembrolizumab in Early-Stage Triple-Negative Breast Cancer

2 Minute Medicine 2024 September 30

1. The 5-year OS rate for pembrolizumab vs placebo was 86.1% vs 81.7% with HR 0.51 (significant).

2. Immune-mediated adverse events grade 3 or higher occurred in 13.0% with pembrolizumab vs 1.5% with placebo.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Triple-negative breast cancer (TNBC) is an aggressive subtype that lacks key therapeutic targets, leading to poorer outcomes. Pembrolizumab, a PD-1 inhibitor, has shown significant benefits in treating early-stage TNBC. This study is the final analysis for neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab for high-risk, early-stage triple-negative breast cancer. The primary endpoints included pathological complete response (pCR) and event-free survival (EFS), and secondary outcomes included overall survival (OS) and safety. Estimated OS at 3, 4, and 5 years between the pembrolizumab–chemotherapy group and the placebo–chemotherapy group, respectively, was 89.5% vs 86.9%, 87.8% vs 83.5%, and 86.6% vs 81.7% with HR 0.87 (non-significant) before the 2-year follow-up and 0.51 (significant) afterwards. The estimated 5-year EFS was 81.2% in the pembrolizumab–chemotherapy group vs 72.2% in the placebo–chemotherapy group with HR 0.65 (significant). The pCR data for this study was reported in an earlier analysis. With regards to safety, treatment-related adverse events of grade 3 or higher occurred in 77.1% in the pembrolizumab–chemotherapy group vs 73.3% in the placebo–chemotherapy group, with the most common events being neutropenia, decreased neutrophil count, and anemia. Immune-mediated adverse events grade 3 or higher occurred in 13.0% in the pembrolizumab–chemotherapy group vs 1.5% in the placebo–chemotherapy group, with the most common events being endocrine in nature. The strengths of this study included the methodology, the follow-up period, the number of participants, and the limitations included comparison against other treatment options. Overall, this study found that neoadjuvant/adjuvant pembrolizumab in addition to standard chemotherapy improves overall and event-free survival in high-risk, early-stage triple-negative breast cancer.

Click to read the study in NEJM

Relevant Reading: Pembrolizumab for early triple-negative breast cancer

In-Depth [ randomized controlled trial]: This phase 3, international, double-blind trial enrolled patients with non-metastatic newly diagnosed TNBC and randomized them (2:1) to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab (pembrolizumab–chemotherapy group, n=784) or neoadjuvant placebo plus chemotherapy followed by adjuvant placebo (placebo–chemotherapy group, n=390). Neoadjuvant therapy consisted of 4 cycles of pembrolizumab/placebo and paclitaxel+carboplatin+doxorubicin/epirubicin+cyclophosphamide. Adjuvant therapy consisted to up to 9 cycles of pembrolizumab/placebo. Median follow-up time was 75.1 months (65.9 to 84.0). Estimated OS at 3, 4, and 5 years between the pembrolizumab–chemotherapy group and the placebo–chemotherapy group, respectively, was 89.5% (95%CI, 87.1-91.5) vs 86.9% (95%CI, 83.1-89.9), 87.8% (95%CI, 85.3-89.9) vs 83.5% (95%CI, 79.4-86.9), and 86.6% (95%CI, 84.0-88.8) vs 81.7% (95%CI, 77.5-85.2) with HR 0.87 (95%CI, 0.57-1.32) before the 2-year follow-up and 0.51 (95%CI, 0.35-0.75) afterwards. Estimated 5-year EFS was 81.2% (95%CI, 78.3-83.8) in the pembrolizumab–chemotherapy group vs 72.2% (95%CI, 67.4-76.4) in the placebo–chemotherapy group with HR 0.65 (95%CI, 0.51-0.83). The pCR data for this study was reported in an earlier analysis. With regards to safety, treatment-related adverse events of grade 3 or higher occurred in 77.1% in the pembrolizumab–chemotherapy group vs 73.3% in the placebo–chemotherapy group, with the most common events being neutropenia, decreased neutrophil count, and anemia. Immune-mediated adverse events grade 3 or higher occurred in 13.0% in the pembrolizumab–chemotherapy group vs 1.5% in the placebo–chemotherapy group, with most common events being endocrine in nature. Overall, this study found that neoadjuvant/adjuvant pembrolizumab in addition to standard chemotherapy improves overall and event-free survival in high-risk, early-stage triple-negative breast cancer.

Originally Published By 2 Minute Medicine®. Reused on Read by QxMD with permission.

©2024 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc.

Add to Saved Papers

Get 1-tap access

Related Resources

For the best experience, use the Read mobile app

Mobile app image

Get seemless 1-tap access through your institution/university

For the best experience, use the Read mobile app

All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.

By using this service, you agree to our terms of use and privacy policy.

Your Privacy Choices Toggle icon

You can now claim free CME credits for this literature searchClaim now

Get seemless 1-tap access through your institution/university

For the best experience, use the Read mobile app