Related Experiment Video
Updated: May 7, 2026
09:29
Studying Triple Negative Breast Cancer Using Orthotopic Breast Cancer Model
Published on: March 20, 2020
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Real-World Analysis of Adverse Events in Patients With Triple-Negative Breast Cancer Receiving Therapy per
Mara Lacy Hofherr1, Andrew A Davis1, Spenser January2
1Siteman Cancer Center, Washington University, St. Louis, MO.
JCO Oncology Practice
|May 5, 2026
Summary
Real-world data show the KEYNOTE-522 regimen for early-stage triple-negative breast cancer (TNBC) had lower pathologic complete response (pCR) rates and higher toxicity than clinical trials. These findings impact TNBC treatment strategies.
Area of Science:
- Oncology
- Clinical Pharmacology
Background:
- Triple-negative breast cancer (TNBC) is an aggressive subtype requiring effective early-stage treatment.
- The KEYNOTE-522 regimen (chemotherapy plus pembrolizumab) is standard for high-risk, early-stage TNBC.
Purpose of the Study:
- To evaluate the real-world clinical effectiveness and toxicity of the KEYNOTE-522 regimen in early-stage TNBC.
- To compare real-world outcomes with pivotal trial data.
Main Methods:
- Retrospective analysis of 675 patients from 19 US sites receiving the KEYNOTE-522 regimen.
- Collection of safety, efficacy, and healthcare utilization data.
Main Results:
- A pathologic complete response (pCR) rate of 54.7% was observed.
- 33.2% of patients experienced chemotherapy dose reductions due to adverse events.
- Immune-related adverse events (irAEs) occurred in 57.5% of patients, with 26.1% experiencing grade 3+ irAEs.
- White patients and older patients (≥65 years) had higher rates of grade 3+ irAEs.
Conclusions:
- Real-world data indicate a lower pCR rate and increased toxicity compared to the KEYNOTE-522 trial.
- Frequent healthcare utilization and rare irAEs were noted.
- Findings necessitate careful clinical management and further validation with real-world datasets.
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