Citations 1
Real-World Analysis of Adverse Events in Patients With Triple-Negative Breast Cancer Receiving Therapy per KEYNOTE-522
Hofherr, Mara, Davis, Andrew A. , January, Spenser E. , Raheem, Farah , Lyons, Lauren , Hsin, Jerline , Kraft, Shawna , Schepers, Allison , Taraba, Jodi L. , Blazawski, Jon , Bohnenkamp, Colleen, Hummert, Shelly, Grate, Lisa , Keisner, S. V., Hobbs, Jacob , Davis, Todd , White, Traci, Sandhu, Avneek Singh, Boulbol, Fouad, Finch, Kelsey , Fahey, Olivia , Resnick, Yonatan , Harwood, K., Armgardt, Emily, Mazewski, Douglas, Svoboda, Alison, Keegan, Aimee , Yu, Wai, Watson-Rose, Meredith, Madden, Katherine, Upton, Charlie, Mina, Lida, Owen, Emily , Clifton, Katherine , Hofherr, Mara Lacy , January, Spenser , Schepers, Allison J , Taraba, Jodi L , Keisner, Sidney V , Harwood, Kayla, Owen, Emily J , Clifton, Katherine , Raheem, Farah , Kraft, Shawna , Hummert, Shelly, Grate, Lisa , Madden, Katherine, Karikalan, Suganya Arunachalam
JCO Oncology Practice | May 5, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available
PURPOSE Triple-negative breast cancer (TNBC) is an aggressive subtype of breast cancer. Early-stage, high-risk patients with TNBC are treated with chemotherapy and pembrolizumab per the KEYNOTE-522 regimen. This report examines real-world clinical effectiveness and toxicity of this regimen. METHODS This 19-site retrospective analysis included all patients who received at least one dose of the KEYNOTE-522 regimen. Safety, efficacy, and health care encounters were collected. RESULTS 675 patients from 19 sites in the United States who received chemotherapy and pembrolizumab for early-stage TNBC were included. 547 (81.0%) patients underwent surgery and 250 (54.7%) patients had a pathologic complete response (pCR). No baseline characteristics were predictive of pCR status. 224 patients (33.2%) had an adverse drug event resulting in ≥1 dose reduction of chemotherapy and were significantly more likely to have residual disease. Immune-related adverse events (irAEs) were observed in 388 (57.5%) patients and grade 3+ irAEs were observed in 176 (26.1%) patients. There was no difference in pCR status between provider's choice chemotherapy schedules. There was no difference of pCR rate between Black and White patients (55.6% v 51.6%, P = .489). White patients were significantly more likely to have any grade and grade 3+ irAEs. Older patients (age ≥65 years) had similar pCR rates compared with younger patients; however, older patients were significantly more likely to have grade 3+ irAEs. CONCLUSIONS In this multi-institutional real-world cohort, we observed a lower pCR rate, higher rates of toxicity, frequent emergency health care utilization, and the reporting of rare irAEs at higher frequency than the KEYNOTE-522 regimen. These findings have important implications for clinical management of patients with early-stage TNBC and warrant further validation with real-world data sets.