Avelumab for Advanced Merkel Cell Carcinoma: Global Real-World Data on Patient Response and Survival.

IF 2.3 Q2 MEDICINE, GENERAL & INTERNAL Pragmatic and Observational Research Pub Date : 2023-11-16 eCollection Date: 2023-01-01 DOI:10.2147/POR.S398151
Rishabh Lohray, Kritin K Verma, Leo L Wang, Dylan Haynes, Daniel J Lewis
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Abstract

Introduction: Avelumab is a programmed cell death-ligand 1 (PD-L1) inhibitor approved by the Food and Drug Administration for advanced Merkel cell carcinoma (MCC). Studies conducted in real-world settings have shed light on its effectiveness and safety in clinical settings.

Areas covered: Real-world studies on avelumab for MCC from North and South America, Europe, and Asia have been presented in this review. Most studies are on patients over age 70 and have a male-predominant sex ratio. Overall response rates range from 29.1% to 72.1%, (disease control rate: 60.0-72.7%; complete response rate: 15.8%-37.2%; partial rate: 18.2-42.1%; stable disease: 7.1-30.9%; progressive disease: 7.1-40.0%) and median progression free survival ranges from 8.1 to 24.1 months depending on the population studied. Immunosuppressed patients appear to benefit from avelumab as well, with response rates equivalent to the general population. Patients receiving avelumab as a first-line agent tend to have better outcomes than those using it as a second-line therapy. Fatigue, infusion-related reactions, and dyspnea were some of the most common adverse events identified in real-world studies. Autoimmune hepatitis and thyroiditis were also observed.

Conclusion: The use of avelumab as a safe and effective treatment option for advanced MCC is supported by real-world data, although additional study is required to assess long-term efficacy and safety outcomes.

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Avelumab用于晚期默克尔细胞癌:患者反应和生存的全球真实世界数据
Avelumab是一种程序性细胞死亡配体1 (PD-L1)抑制剂,已被美国食品和药物管理局批准用于晚期默克尔细胞癌(MCC)。在现实环境中进行的研究揭示了其在临床环境中的有效性和安全性。涵盖领域:本综述介绍了来自北美和南美、欧洲和亚洲的关于avelumab治疗MCC的实际研究。大多数研究都是针对70岁以上的患者,并且以男性为主。总有效率为29.1% - 72.1%,(疾病控制率:60.0-72.7%;完全缓解率:15.8%-37.2%;部分率:18.2-42.1%;稳定期:7.1-30.9%;进展性疾病:7.1-40.0%),根据研究人群,中位无进展生存期为8.1 - 24.1个月。免疫抑制患者似乎也受益于avelumab,其应答率与一般人群相当。接受avelumab作为一线药物的患者往往比将其作为二线治疗的患者有更好的结果。疲劳、输液相关反应和呼吸困难是现实世界研究中发现的最常见的不良事件。自身免疫性肝炎和甲状腺炎也被观察到。结论:使用avelumab作为一种安全有效的晚期MCC治疗方案得到了现实世界数据的支持,尽管还需要进一步的研究来评估长期疗效和安全性结果。
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Pragmatic and Observational Research
Pragmatic and Observational Research MEDICINE, GENERAL & INTERNAL-
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期刊介绍: Pragmatic and Observational Research is an international, peer-reviewed, open-access journal that publishes data from studies designed to closely reflect medical interventions in real-world clinical practice, providing insights beyond classical randomized controlled trials (RCTs). While RCTs maximize internal validity for cause-and-effect relationships, they often represent only specific patient groups. This journal aims to complement such studies by providing data that better mirrors real-world patients and the usage of medicines, thus informing guidelines and enhancing the applicability of research findings across diverse patient populations encountered in everyday clinical practice.
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