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Multicenter Study
. 2025 Aug;213(1):71-80.
doi: 10.1007/s10549-025-07758-8. Epub 2025 Jul 4.

Adverse events in patients treated with neoadjuvant chemo/immunotherapy for triple negative breast cancer: results from seven academic medical centers

Jessica Mezzanotte-Sharpe  1 , Chih-Yuan Hsu  2 , David Choi  3 , Hollie Sheffield  4 , Sara Zelinskas  5 , Ekaterina Proskuriakova  6   7 , Mateo Montalvo  8 , Danelle S Lee  8 , Jennifer G Whisenant  1 , Keaton Gaffney  9 , Michael S Thompson  9 , Kim Blenman  8 , Karine Tawagi  6   10 , Lynn Symonds  11   12 , Cesar Santa-Maria  3 , Nisha Unni  4 , Dionisia Quiroga  5 , Yu Shyr  2 , Laura C Kennedy  13
Affiliations
Multicenter Study

Adverse events in patients treated with neoadjuvant chemo/immunotherapy for triple negative breast cancer: results from seven academic medical centers

Jessica Mezzanotte-Sharpe et al. Breast Cancer Res Treat. 2025 Aug.

Abstract

Purpose: The standard-of-care neoadjuvant treatment for early-stage or locally advanced triple negative breast cancer (TNBC) is the KEYNOTE-522 regimen that combines pembrolizumab and chemotherapy. Although this approach has superior response and survival rates, high-grade adverse events (AEs) are common. Real-world data from a diverse patient population is needed to better understand practice patterns and the impact of immunotherapy in TNBC patients.

Methods: Medical records from TNBC patients were retrospectively reviewed during neoadjuvant and adjuvant treatment with pembrolizumab and chemotherapy. CTCAE version 5.0 was used to grade AEs. Variables were reported with descriptive statistics, and AE, pCR and hospitalization rates were estimated with 95% confidence intervals.

Results: We identified 415 patients from seven academic medical centers; 60% identified as White and 21% as Black. pCR rate was 52%. 88% of patients experienced an AE, 38% experienced a grade 3+ AE, and 31% stopped pembrolizumab early. Hospitalization rate was 26%. There were no statistically significant differences in AE, pCR or hospitalization rates between White and Black patients. Obese patients had a statistically significant higher hospitalization rate (p = 0.014). There were 18 deaths during treatment, mainly from progressive TNBC.

Conclusion: This is one of the largest real-world, diverse patient cohorts for TNBC patients treated with chemotherapy and pembrolizumab. pCR rate was lower than that reported in the KEYNOTE-522 study and in smaller real-world studies, potentially due to high rates of pembrolizumab and chemotherapy discontinuation. AEs and hospitalizations were common, with obese patients more likely to be hospitalized than patients with a normal BMI.

Keywords: Immune-related adverse events; Pembrolizumab; Triple negative breast cancer.

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Conflict of interest statement

Declarations. Competing interests: JMS, CYH, HS, SZ, DC, EP, MM, DSL, KG, JGW, and LS have no conflicts of interest to disclose. KT has served on advisory boards for Seagen and AstraZeneca. CMS has served on steering committees for Gilead and Greenwich Life Sciences and advisory boards for Merck, BMS, Pfizer, Lily, Daiichi/AstraZeneca, Seattle Genetics, CALIBR/SCRIPPs, and Immunomic Therapeutics. CSM has research support (to institution) from Merck, BMS, Pfizer, AstraZeneca, GSK, Celldex, Novartis, and Genentech. NU has COI to disclose for Pfizer and Gilead Sciences. DQ has received consulting fees from Cardinal Health, Inc. LCK has received consulting fees from AstraZeneca and Daiichi Sankyo as well as research funding from Roche-Genentech and Puma Biotechnology. Ethical approval: This is an observational study. The VUMC IRB confirmed that no ethical approval was required. Consent to participate: Due to the observational nature of this project as well as data de-identification, this work was granted a waiver of informed consent from the VUMC IRB.

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