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英国在2019年冠状病毒病大流行期间引入的实体癌临时肿瘤治疗的疗效和安全性:一项基于证据的回顾性分析。

Efficacy and safety of interim oncology treatments introduced for solid cancers during the COVID-19 pandemic in England: a retrospective evidence-based analysis.

作者信息

Lythgoe Mark P, Emhardt Alica-Joana, Naci Huseyin, Krell Jonathan, Sullivan Richard, Aggarwal Ajay

机构信息

Department of Surgery & Cancer, Imperial College London, London, UK.

Department of Health Services Research & Policy, London School of Hygiene & Tropical Medicine, London; Department of Medicine III, LMU University Hospital, LMU Munich, Munich, Germany.

出版信息

Lancet Reg Health Eur. 2024 Sep 10;46:101062. doi: 10.1016/j.lanepe.2024.101062. eCollection 2024 Nov.

Abstract

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.

摘要

背景

新冠疫情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新冠疫情期间临时SACT治疗方案,评估支持纳入的证据,并描述这些方案如何融入常规癌症护理。

方法

我们对英国国家医疗服务体系(NHS)英格兰在新冠疫情期间认可的临时全身抗癌治疗进行了回顾性分析。通过在疫情背景下比较关键关键试验的数据,将临时治疗方案与基线(替代)治疗方案在临床疗效和潜在益处(如降低免疫抑制或改善不良反应谱)方面进行比较。此外,我们评估了这些临时SACT方案的演变,探讨它们是否已融入当前治疗路径,或者在疫情结束时是否不再可用。

结果

2020年3月至2021年8月期间,NHS英格兰认可了31种针对实体癌的临时肿瘤治疗方案,涵盖36个适应症。临时治疗主要集中在转移性疾病(83%;30/36),更多地使用免疫检查点抑制剂(45%;14/31)和靶向治疗(26%;8/31),以替代细胞毒性化疗。总体而言,36%(13/36)的治疗方案由于证据不足,与基线治疗相比可能没有疗效。对于那些有疗效的方案,39%(9/23)具有更高的疗效(如总生存期),26%(6/23)疗效相当,35%(8/23)疗效较低。53%(19/36)的临时治疗方案具有更好或相当的毒性特征(可评估时),和/或与免疫抑制降低相关。近一半(47%;17/36)的临时治疗方案没有英国市场授权,属于“超适应症”使用。分析疫情结束时(2023年5月)临时方案的可及性发现,19种(53%,19/36)临时方案完全可用,另有4种(11%,4/36)治疗方案部分可用。

解读

在英格兰推出的针对一系列实体癌的临时SACT方案,在疫情期间支持了癌症服务的提供。大多数临时治疗方案并未显示出更高的疗效,但在疫情背景下提供了其他重要益处(如降低免疫抑制)。

资金来源

无。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/47af/11415950/fb547cf25951/gr1ab.jpg

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