在美国，FDA 批准 pembrolizumab 的肿瘤不可知适应证之前和之后，在老年癌症患者中的使用情况。
Use of pembrolizumab among older adults with cancer in the United States, before and after FDA approval of its tumor-agnostic indication.
机构信息
Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, Maryland, USA.
Kelly Services, Inc, Rockville, Maryland, USA.
出版信息
Pharmacoepidemiol Drug Saf. 2024 Jan;33(1):e5745. doi: 10.1002/pds.5745. Epub 2023 Dec 29.
INTRODUCTION
Pembrolizumab, an anticancer immunotherapy agent, has received multiple approvals since its first approval by the U.S. Food and Drug Administration (FDA) in 2014. Limited data exist on its real-world use and shifts post tumor-agnostic approval in 2017 for the treatment of patients with any microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) solid tumors. This study analyzes pembrolizumab's pre and post-tumor-agnostic approval use among older U.S. adults, revealing its evolving role in oncology practice.
METHODS
Using the Surveillance, Epidemiology and End Results (SEER)-Medicare data (2014-2019), we examined the cancer sites of pembrolizumab recipients before and after tumor-agnostic approval. Cancer sites were classified based on the timing of site-specific approvals (before/after tumor-agnostic approval) or no site-specific approval, and inclusion in MSI-H/dMMR clinical trials.
RESULTS
The total number of pembrolizumab recipients increased from 4221 in the pre-agnostic period to 20 479 in the post-agnostic period. Pembrolizumab was used for a broad range of cancer types, including cancers that had no FDA-approved site-specific indications at the time of use (25.8% in pre- and 24.6% in post-agnostic periods). The proportion of pembrolizumab recipients receiving pembrolizumab for cancers with site-specific approvals before tumor-agnostic approval decreased from 77.3% to 70.8%. The proportion of pembrolizumab recipients receiving pembrolizumab for cancers that gained site-specific approvals following tumor-agnostic approval almost doubled (6.8% to 13.0%). The proportion of pembrolizumab recipients with cancers included in MSI-H/dMMR trials also doubled (12.3% to 25.5%) following tumor-agnostic approval.
CONCLUSIONS
Pembrolizumab use has expanded over time among older adults with cancer, extending beyond those with FDA-approved site-specific indications.
简介
自 2014 年美国食品和药物管理局（FDA）首次批准以来，抗癌免疫疗法药物帕博利珠单抗已获得多项批准。在 2017 年肿瘤不可知论批准后，其在真实世界中的使用情况和变化的数据有限，用于治疗任何微卫星不稳定高/错配修复缺陷（MSI-H/dMMR）实体瘤患者。本研究分析了在美国老年人中，帕博利珠单抗在肿瘤不可知论批准前后的使用情况，揭示了其在肿瘤学实践中的不断发展的作用。
方法
利用监测、流行病学和最终结果（SEER）-医疗保险数据（2014-2019 年），我们检查了肿瘤不可知论批准前后接受帕博利珠单抗治疗的患者的癌症部位。根据特定部位批准（肿瘤不可知论批准前/后）的时间或无特定部位批准的时间，以及是否纳入 MSI-H/dMMR 临床试验，对癌症部位进行分类。
结果
帕博利珠单抗的总人数从肿瘤不可知论前的 4221 人增加到肿瘤不可知论后的 20479 人。帕博利珠单抗用于广泛的癌症类型，包括在使用时没有 FDA 批准的特定部位适应证的癌症（肿瘤不可知论前为 25.8%，肿瘤不可知论后为 24.6%）。在肿瘤不可知论批准前有特定部位批准的帕博利珠单抗接受者中，接受帕博利珠单抗治疗的比例从 77.3%降至 70.8%。在肿瘤不可知论批准后获得特定部位批准的帕博利珠单抗接受者中，接受帕博利珠单抗治疗的比例几乎翻了一番（从 6.8%到 13.0%）。在肿瘤不可知论批准后，纳入 MSI-H/dMMR 试验的帕博利珠单抗接受者的比例也翻了一番（从 12.3%到 25.5%）。
结论
随着时间的推移，癌症老年患者中帕博利珠单抗的使用范围不断扩大，超出了具有 FDA 批准的特定部位适应证的患者。
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