Real-World Toxicities and Outcomes of Pembrolizumab in Early-Stage Triple-Negative Breast Cancer
Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design and Setting
2.2. Participants
2.3. Data Collection
2.4. Outcomes
2.5. Data Analysis
2.6. Ethics
3. Results
3.1. Participants
3.2. Efficacy
3.3. Immunotherapy-Related Adverse Events
3.4. Neoadjuvant Phase
3.5. Adjuvant Phase
3.6. Treatment Discontinuation
3.7. Hospital Admission
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
| TNBC | Triple-Negative Breast Cancer |
| KEYNOTE-522 | Name of the Phase III Pembrolizumab Clinical Trial in Early-Stage TNBC |
| irAE/irAEs | Immune-Related Adverse Event(s) |
| pCR | Pathological Complete Response |
| PD-1 | Programmed Cell Death Protein 1 |
| ER | Estrogen Receptor |
| PR | Progesterone Receptor |
| HER2 | Human Epidermal Growth Factor Receptor 2 |
| LHSC | London Health Sciences Centre |
| WRH | Windsor Regional Hospital |
| REDCap | Research Electronic Data Capture |
| AJCC | American Joint Committee on Cancer |
| CTCAE | Common Terminology Criteria for Adverse Events |
| REB | Research Ethics Board |
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| Characteristics | Real-World (N = 79) | KEYNOTE-522 (N = 784) |
|---|---|---|
| Age | ||
| Median (range)—yr | 53 (27–79) | 49 (22–80) |
| <65 yr—no. (%) | 62 (78.5) | 701 (89.4) |
| Menopausal status—no. (%) | ||
| Premenopausal | 29 (36.7) | 438 (55.9) |
| Postmenopausal | 50 (63.3) | 345 (44.0) |
| Primary tumor classification—no. (%) | ||
| T1 to T2 | 59 (74.7) | 580 (74.0) |
| T3 to T4 | 20 (25.3) | 204 (26.0) |
| Nodal involvement—no. (%) | ||
| Positive | 46 (58.2) | 405 (51.7) |
| Negative | 33 (41.8) | 379 (48.3) |
| Overall disease stage—no. (%) | ||
| Stage II | 41 (51.9) | 590 (75.3) |
| Stage III | 38 (48.1) | 194 (24.7) |
| HER2 status score—no. (%) | ||
| 0–1 | 60 (75.9) | 595 (75.9) |
| 2+ | 19 (24.1) | 188 (24.0) |
| Event | Real-World (N = 79) | KEYNOTE-522 (N = 781) |
|---|---|---|
| Arthritis | 2 (2.5%) | 0 |
| Neurotoxicity | 1 (1.3%) | 0 |
| Dermatitis | 12 (15.2%) | 34 (4.4%) |
| Hypothyroidism | 5 (6.3%) | 107 (13.7%) |
| Colitis | 4 (5.1%) | 13 (1.7%) |
| Myositis | 2 (2.5%) | 3 (0.4%) |
| Renal/Nephritis | 1 (1.3%) | 7 (0.9%) |
| Adrenal insufficiency | 1 (1.3%) | 18 (2.3%) |
| Hepatitis | 1 (1.3%) | 11 (1.4%) |
| Pneumonitis | 1 (1.3%) | 10 (1.3%) |
| Hyperthyroidism | 0 | 36 (4.6%) |
| Diabetes | 0 | 2 (0.3%) |
| Hypophysitis | 0 | 14 (1.8%) |
| Event | Real-World (N = 79) | KEYNOTE-522 (N = 781) |
|---|---|---|
| Arthritis | 1 (1.3%) | 0 |
| Neurotoxicity | 0 | 0 |
| Dermatitis | 2 (2.5%) | 30 (3.8%) |
| Hypothyroidism | 0 | 3 (0.4%) |
| Colitis | 2 (2.5%) | 7 (0.9%) |
| Myositis | 0 | 0 |
| Renal/Nephritis | 1 (1.3%) | 7 (0.9%) |
| Adrenal insufficiency | 0 | 10 (1.3%) |
| Hepatitis | 0 | 9 (1.2%) |
| Pneumonitis | 0 | 3 (0.4%) |
| Hyperthyroidism | 0 | 2 (0.3%) |
| Diabetes | 0 | 2 (0.3%) |
| Hypophysitis | 0 | 8 (1.0%) |
| Event | Real-World (N = 68) | KEYNOTE-522 (N = 547) |
|---|---|---|
| Arthritis | 1 (1.5%) | 0 |
| Neurotoxicity | 3 (4.4%) | 0 |
| Dermatitis | 5 (7.4%) | 9 (1.6%) |
| Hypothyroidism | 8 (11.8%) | 10 (1.8%) |
| Colitis | 5 (7.4%) | 2 (0.4%) |
| Myositis | 1 (1.5%) | 1 (0.2%) |
| Renal/Nephritis | 0 | 1 (0.2%) |
| Adrenal insufficiency | 2 (2.9%) | 3 (0.5%) |
| Hepatitis | 0 | 0 |
| Pneumonitis | 1 (1.5%) | 5 (0.9%) |
| Hyperthyroidism | 0 | 4 (0.7%) |
| Diabetes | 1 (1.5%) | 1 (0.2%) |
| Hypophysitis | 1 (1.5%) | 0 |
| Event | Real-World (N = 68) | KEYNOTE-522 (N = 547) |
|---|---|---|
| Arthritis | 0 | 0 |
| Neurotoxicity | 1 (1.5%) | 0 |
| Dermatitis | 0 | 4 (0.7%) |
| Hypothyroidism | 1 (1.5%) | 3 (0.4%) |
| Colitis | 1 (1.5%) | 1 (0.2%) |
| Myositis | 0 | 0 |
| Renal/Nephritis | 0 | 0 |
| Adrenal insufficiency | 1 (1.5%) | 0 |
| Hepatitis | 0 | 0 |
| Pneumonitis | 1 (1.5%) | 2 (0.4%) |
| Hyperthyroidism | 0 | 0 |
| Diabetes | 0 | 1 (0.2%) |
| Hypophysitis | 0 | 0 |
| Characteristic | Value |
|---|---|
| Total number of patients with discontinuation | 18 (22.8%) |
| Stage at diagnosis | |
| Stage II | 8 (44.4%) |
| Stage III | 10 (55.6%) |
| Mean % of planned immunotherapy received | 46.2% ± 21.6 |
| Timing of discontinuation | |
| Neoadjuvant phase | 11 (61.1%) |
| Adjuvant phase | 7 (38.9%) |
| irAEs leading to discontinuation | |
| Colitis | 8 (44.4%) |
| Dermatitis | 5 (27.8%) |
| Hypothyroidism | 3 (16.7%) |
| Adrenal insufficiency | 1 (5.6%) |
| Arthritis | 1 (5.6%) |
| Pathological complete response (pCR) | 15 (83.3%) |
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Share and Cite
Boujeke, E.J.; Catalan, A.; Arayan, L.; Mina, A.P.; James-McDonald, C.E.; Gupta, R.; Kulkarni, S.; Nasser, A.; Chowdhury, D.; Brackstone, M.; et al. Real-World Toxicities and Outcomes of Pembrolizumab in Early-Stage Triple-Negative Breast Cancer. Curr. Oncol. 2026, 33, 513. https://doi.org/10.3390/curroncol33090513
Boujeke EJ, Catalan A, Arayan L, Mina AP, James-McDonald CE, Gupta R, Kulkarni S, Nasser A, Chowdhury D, Brackstone M, et al. Real-World Toxicities and Outcomes of Pembrolizumab in Early-Stage Triple-Negative Breast Cancer. Current Oncology. 2026; 33(9):513. https://doi.org/10.3390/curroncol33090513
Chicago/Turabian StyleBoujeke, Emmanuel Joran, Aaron Catalan, Laurice Arayan, Alfred Patrick Mina, Christian Edward James-McDonald, Rasna Gupta, Swati Kulkarni, Abdullah Nasser, Deepro Chowdhury, Muriel Brackstone, and et al. 2026. "Real-World Toxicities and Outcomes of Pembrolizumab in Early-Stage Triple-Negative Breast Cancer" Current Oncology 33, no. 9: 513. https://doi.org/10.3390/curroncol33090513
APA StyleBoujeke, E. J., Catalan, A., Arayan, L., Mina, A. P., James-McDonald, C. E., Gupta, R., Kulkarni, S., Nasser, A., Chowdhury, D., Brackstone, M., Mathews, J., & Hamm, C. (2026). Real-World Toxicities and Outcomes of Pembrolizumab in Early-Stage Triple-Negative Breast Cancer. Current Oncology, 33(9), 513. https://doi.org/10.3390/curroncol33090513

