接受 Pembrolizumab 治疗的早期三阴性乳腺癌患者真实世界中与免疫相关的不良事件。

IF 4.7 3区 医学 Q1 ONCOLOGY JCO oncology practice Pub Date : 2024-10-10 DOI:10.1200/OP.24.00371
Athira Jayan, Jasmine S Sukumar, Benjamin Fangman, Tejal Patel, Akshara Singareeka Raghavendra, Diane Liu, Sarah Pasyar, Ronald Rauch, Karen Basen-Engquist, Debasish Tripathy, Yinghong Wang, Sonya S Khan, Carlos H Barcenas
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引用次数: 0

摘要

目的:在高风险早期三阴性乳腺癌(TNBC)化疗中加入 pembrolizumab 可改善癌症预后。然而,pembrolizumab 会诱发各种免疫相关不良事件(irAEs),其中一些可能是严重的或终身性的。这项回顾性研究描述了接受pembrolizumab治疗的TNBC患者发生irAEs的真实情况:我们评估了一家综合癌症中心和一家社区医院在2021年至2023年间接受pembrolizumab联合化疗的TNBC患者的irAEs,不包括参加临床试验的患者。我们采用国家指南对毒性进行分级。逻辑回归评估了临床病理变量对irAEs的影响,并对协变量进行了调整:我们确定了 233 名患者,中位年龄为 51 岁,62% 为 TNBC II 期,35% 为 TNBC III 期,25% 为西班牙裔,21% 为黑人,42% 为白人。80名患者(34%)出现了100种不同的虹膜AE。最常见的irAE是内分泌疾病(52%)和消化道疾病(23%);26例≥3级irAE均导致住院治疗,其中最常见的是消化道疾病(13例);45例患者需要全身使用类固醇,16例患者需要额外的免疫抑制治疗,32例患者因irAE停用了pembrolizumab。两名出现结肠炎的患者最终死于并发症。在最后一次随访时,大多数(67 例)irAEs 尚未缓解,但 55%(37/67)的irAEs 已改善至 1 级。没有临床病理因素与虹膜AE的发生或严重程度相关:结论:在这一真实世界的不同人群中,我们观察到的irAEs发生率与KEYNOTE-522相当,其中内分泌疾病最为普遍,但消化道irAEs也很普遍且严重。这强调了一个关键问题,即随着pembrolizumab越来越多地用于早期TNBC,它可能会对患者的长期生存产生影响。
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Real-World Immune-Related Adverse Events in Patients With Early Triple-Negative Breast Cancer Who Received Pembrolizumab.

Purpose: The addition of pembrolizumab to chemotherapy in high-risk early triple-negative breast cancer (TNBC) improves cancer outcomes. However, pembrolizumab induces varied immune-related adverse events (irAEs) where some can be severe or lifelong. This retrospective study describes real-world patterns of irAEs in patients with TNBC who received pembrolizumab.

Methods: We evaluated irAEs in patients with TNBC from a comprehensive cancer center and a community hospital who received pembrolizumab with chemotherapy between 2021 and 2023, excluding those enrolled in clinical trials. We used national guidelines to grade toxicities. Logistic regression assessed the effect of clinicopathologic variables on irAEs adjusting for covariates.

Results: We identified 233 patients with a median age of 51 years, 62% had stage II TNBC, 35% had stage III TNBC, 25% were Hispanic, 21% were Black, and 42% were White. Eighty patients (34%) developed 100 separate irAEs. The most common irAEs were endocrinopathies (52%) and GI (23%); there were 26 grade ≥3 irAEs, which all resulted in hospitalization, the most common being GI (13 instances); 45 required systemic steroids, 16 required additional immunosuppressive therapy, and 32 patients discontinued pembrolizumab because of irAEs. Two patients who developed colitis eventually died due to complications. Most (67 instances) irAEs were unresolved at the time of last follow-up, but 55% (37/67) had improved to grade 1. No clinicopathologic factors were associated with the development or severity of irAEs.

Conclusion: In this real-world diverse population, we observed rates of irAEs comparable with KEYNOTE-522, where endocrinopathies were the most prevalent, but GI irAEs were also prevalent and severe. This emphasizes a critical issue as pembrolizumab is increasingly being used in early TNBC and could have long-term survivorship implications.

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CiteScore
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