ArticleBreast (Edinburgh, Scotland)2025
Immune-related adverse events among patients with early-stage triple-negative breast cancer treated with pembrolizumab plus chemotherapy: real-world data from the Neo-Real/GBECAM 0123 study.
Article in Breast (Edinburgh, Scotland), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Toxicity profile and tolerability of immune checkpoint inhibitors for the treatment of early-stage breast cancer: a systematic review and meta-analysis.Breast (Edinburgh, Scotland) · 2026Pooled it
- Advancing immune checkpoint inhibitor rechallenge: key insights into efficacy, safety, and personalized strategies in advanced solid tumors.Frontiers in oncology · 2026Pooled it
- BRCA pathogenic variants and response in early TNBC patients treated with neoadjuvant pembrolizumab: outcomes of the BRCAPATH study.Breast cancer (Tokyo, Japan) · 2026Article
- Neoadjuvant therapy for stage II-III triple-negative breast cancer: Current evidence, clinical boundaries and emerging strategies (Review).Oncology letters · 2026Review
- Real-World Toxicities and Outcomes of Pembrolizumab in Early-Stage Triple-Negative Breast Cancer.Current oncology (Toronto, Ont.) · 2026Article
- Oncofertility in the Age of HER2 Blockade, Immunotherapy, PARP inhibitors, CDK4/6 inhibitors and Endocrine Treatment: Unanswered Questions in Breast Cancer.Current treatment options in oncology · 2026Review
- Treatment patterns and safety of adjuvant therapy after chemoimmunotherapy for early-stage triple-negative breast cancer: real-world data from the Neo-Real/GBECAM 0123 study.Breast cancer research and treatment · 2026Article
- Neoadjuvant pembrolizumab plus chemotherapy in older patients with early-stage triple-negative breast cancer: real-world insights from neo-real/GBECAM-0123.NPJ breast cancer · 2026Article
- A Perplexing Plexopathy After Pembrolizumab Therapy in Early-Stage Triple-Negative Breast Cancer.Current oncology (Toronto, Ont.) · 2026Article
- Multiple Endocrinology Immune-Related Adverse Events (irAEs) Related to Pembrolizumab as Neoadjuvant Treatment in Two Cases of TNBC Patients: Case Reports and Literature Review.Current oncology (Toronto, Ont.) · 2026Review
- Risk factors for cutaneous immune-related adverse events: a systematic scoping review.Frontiers in immunology · 2026Article
- Case Report: Aplastic anemia associated with parvovirus B19 infection following neoadjuvant pembrolizumab-based chemoimmunotherapy for triple-negative breast cancer.Frontiers in oncology · 2026Article
- Emerging biomarkers of immune checkpoint inhibitor toxicity in triple-negative breast cancer: a mini-review.Frontiers in immunology · 2026Review
- The role of AI-driven decision support in immunotherapy for predicting pathological complete response in triple-negative breast cancer.Frontiers in oncology · 2026Article
- BRCA1 and 2 Mutations and Efficacy of Pembrolizumab-Based Neoadjuvant Chemotherapy in Triple-Negative Breast Cancer: A Real-World Multicenter Analysis.Journal of clinical medicine · 2025Article
- Review
- Immune-Related Adverse Events Among Patients With Endometrial Cancer Receiving Pembrolizumab Alone or With Other Treatments: A Single-Center Real-World Experience.Journal of immunotherapy (Hagerstown, Md. : 1997)Article
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Authors and funding
27 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPembrolizumab combined with neoadjuvant chemotherapy is the standard of care for stage II-III triple-negative breast cancer (TNBC) based on the KEYNOTE-522 trial. However, 13 % of patients experienced immune-related adverse events (irAEs) of grade ≥3 in the trial. This study aims to describe patterns of irAEs in a real-world scenario during treatment with pembrolizumab for early-stage TNBC.
methodsPatients treated with neoadjuvant pembrolizumab plus chemotherapy across ten Brazilian cancer centers were evaluated in the Neo-Real/GBECAM0123 study. This analysis focuses on irAE evaluation, including time to onset, management, and association between irAEs and pathological complete response (pCR).
resultsA total of 368 patients were included. Overall, 31 % of patients (n = 114) presented with any grade irAEs. Most of irAEs (72.8 %) occurred during the neoadjuvant phase while 28.1 % happened during the adjuvant period. The most frequent irAEs were endocrine (12.8 % of the entire cohort), cutaneous (7.6 %) and gastrointestinal (7.1 %). A total of 50 patients (13.6 %) experienced grade ≥3 irAEs, predominantly gastrointestinal (32 %). 58 patients (56 %) needed corticosteroids. Immunotherapy rechallenge was possible in 53 % of the cases; permanent discontinuation of pembrolizumab was necessary for 16 %. No significant association was observed between irAEs and clinic-pathologic features nor pCR status.
conclusionsIn this real-world analysis, we observed a similar incidence of irAEs as reported in the KEYNOTE-522 trial. Most patients experienced resolution of their irAEs, but some required permanent discontinuation of pembrolizumab. Additionally, there were lasting dysfunctions, particularly endocrine, demanding lifelong support. Careful monitoring and management of these events are essential.
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