英格兰 COVID-19 大流行期间针对实体瘤引入的临时肿瘤治疗的有效性和安全性:基于证据的回顾性分析

IF 13.6 Q1 HEALTH CARE SCIENCES & SERVICES Lancet Regional Health-Europe Pub Date : 2024-09-10 DOI:10.1016/j.lanepe.2024.101062
Mark P. Lythgoe , Alica-Joana Emhardt , Huseyin Naci , Jonathan Krell , Richard Sullivan , Ajay Aggarwal
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引用次数: 0

摘要

背景COVID-19 全球大流行给癌症服务带来了前所未有的压力,需要新的临时全身抗癌治疗 (SACT) 方案来降低患者风险并维持癌症服务。在本研究中,我们分析了英格兰推荐的 COVID-19 SACT 临时治疗方案,评估了支持纳入这些方案的证据,并说明了这些方案是如何被纳入常规癌症治疗的。通过比较关键关键试验的临床疗效和潜在益处(如减少免疫抑制或改善不良反应),我们将临时治疗方案与基线(替代)治疗方案进行了比较。此外,我们还评估了这些临时 SACT 方案的演变情况,探讨这些方案是否已被纳入当前的治疗路径,或者在大流行结束时是否已不再适用。研究结果英格兰国家医疗服务体系在 2020 年 3 月至 2021 年 8 月期间批准了 31 种针对实体瘤的临时肿瘤治疗方案,涉及 36 种适应症。临时疗法主要针对转移性疾病(83%;30/36),允许更多地使用免疫检查点抑制剂(45%;14/31)和靶向疗法(26%;8/31),以取代细胞毒性化疗。总体而言,由于证据不足,36%(13/36)的疗法无法与基线疗法进行疗效比较。对于那些有疗效的疗法,39%(9/23)的疗效较好(如总生存期),26%(6/23)的疗效不明显,35%(8/23)的疗效较低。53%(19/36)的中期疗法具有较好的毒性或毒性不明显(如可评估),和/或与免疫抑制减少有关。近一半(47%;17/36)的临时疗法没有获得英国市场授权,被归类为 "非标签 "使用。对大流行结束时(2023 年 5 月)的临时治疗方案使用情况进行分析,发现有 19 种(53% 19/36)临时治疗方案完全可用,另有 4 种(11% 4/36)治疗方案部分可用。大多数临时疗法并未显示出卓越的疗效,但在大流行的背景下提供了其他重要益处(如减少免疫抑制)。
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Efficacy and safety of interim oncology treatments introduced for solid cancers during the COVID-19 pandemic in England: a retrospective evidence-based analysis

Background

The COVID-19 global pandemic placed unprecedented pressure on cancer services, requiring new interim Systemic Anti-Cancer Treatments (SACT) options to mitigate risks to patients and maintain cancer services. In this study we analyse interim COVID-19 SACT therapy options recommended in England, evaluating the evidence supporting inclusion and delineating how these have been integrated into routine cancer care.

Methods

We performed a retrospective analysis of interim Systemic Anti-Cancer Treatments endorsed by NHS England during the COVID-19 pandemic. Interim therapy options were compared to baseline (replacement) therapies by comparing data from the key pivotal trial(s) in terms of clinical efficacy and potential benefits (e.g., reduced immunosuppression or improved adverse effect profile) within the context of the pandemic. Furthermore, we evaluated the evolution of these interim SACT options, exploring if these have been integrated into current treatment pathways or are no longer accessible at the pandemic end.

Findings

31 interim oncology treatment options, across 36 indications, for solid cancers were endorsed by NHS England between March 2020 and August 2021. Interim therapies focused on the metastatic setting (83%; 30/36), allowing greater utilisation of immune checkpoint inhibitors (45%; 14/31) and targeted therapies (26%; 8/31), in place of cytotoxic chemotherapy. Overall, 36% (13/36) of therapies could not have efficacy compared with baseline treatments due to a paucity of evidence. For those which could, 39% (9/23) had superior efficacy (e.g., overall survival), 26% (6/23) had equivocal efficacy and 35% (8/23) lower efficacy. 53% (19/36) of interim therapies had better or equivocal toxicity profiles (when assessable), and/or were associated with reduced immunosuppression. Almost half (47%; 17/36) of interim therapies did not have UK market authorisation, being classified as ‘off label’ use. Analysing access to interim options at the end of the pandemic (May 2023) identified 19 (53% 19/36) interim options were fully available, and a further four (11% 4/36) therapies were partially available.

Interpretation

Interim SACT options, introduced in England, across a range of solid cancers supported delivery of cancer services during the pandemic. Most interim therapies did not demonstrate superior efficacy, but provided other important benefits (e.g., reduced immunosuppression) in the context of the pandemic.

Funding

None.

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来源期刊
CiteScore
19.90
自引率
1.40%
发文量
260
审稿时长
9 weeks
期刊介绍: The Lancet Regional Health – Europe, a gold open access journal, is part of The Lancet's global effort to promote healthcare quality and accessibility worldwide. It focuses on advancing clinical practice and health policy in the European region to enhance health outcomes. The journal publishes high-quality original research advocating changes in clinical practice and health policy. It also includes reviews, commentaries, and opinion pieces on regional health topics, such as infection and disease prevention, healthy aging, and reducing health disparities.
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