Clinical benefit evaluation of drug treatment regimens for advanced lung cancer:based on ASCO-VF and ESMO-MCBS

IF 4.5 2区 医学 Q1 ONCOLOGY Lung Cancer Pub Date : 2024-11-01 DOI:10.1016/j.lungcan.2024.108001
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Abstract

Background

With the increasing use of novel targeted drugs and immune checkpoint inhibitors (ICIs) for lung cancer (LC), the life expectancy of patients with LC has notably increased. In China, many drugs with the same mechanism of action have been approved by the National Medical Products Administration (NMPA) through phase III randomized controlled trials (RCTs). However, differences occur in these drugs’ efficacy and adverse effects, all of which have been compared with standard treatments, and data from head-to-head studies are lacking.

Methods

The key RCTs of EGFR tyrosine kinase inhibitors (EGFR-TKIs), ALK-TKIs, and ICIs approved by NMPA in advanced LC in China were searched and divided into five groups. The American Society of Clinical Oncology Value Framework (ASCO-VF v2) and European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS v1.1) were used to evaluate the net health benefits (NHB) of RCTs, including efficacy, adverse reactions, and patient-reported outcomes (PROs), etc. The consistency of the ASCO-VF and ESMO-MCBS was compared.

Results

As of September 2024, 37 RCTs have been included in the ASCO-VF and ESMO-MCBS. NHB scores ranged from 12.30 to 93.25. Nineteen trials met the ASCO-VF “substantial benefit”, and 28 trials achieved the ESMO-MCBS “substantial benefit”. Except for icotinib, dacomitinib, and befotertinib, all EGFR-TKIs and ALK-TKIs met the threshold of two frameworks. In the ICI regimens, eight regimens met the threshold of “ substantial benefit ” as defined by the two frameworks and nine studies showed conflicting results. The correlation coefficient of the 37 pairs of scores in the advanced LC study was estimated to be 0.473(Spearman), and the consistency analysis showed fair agreement.(κ = 0.265, p = 0.001).

Conclusions

ASCO-VF and ESMO-MCBS focus on clinical efficacy and consider the adverse effects of drugs and PROs. We look forward to head-to-head studies on the different treatment options and advocate refining the ESMO-MCBS.
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晚期肺癌药物治疗方案的临床效益评估:基于 ASCO-VF 和 ESMO-MCBS。
背景:随着新型靶向药物和免疫检查点抑制剂(ICIs)越来越多地用于肺癌治疗,肺癌患者的预期寿命显著延长。在中国,许多具有相同作用机制的药物已通过 III 期随机对照试验(RCT)获得国家医药产品管理局(NMPA)批准。然而,这些药物在疗效和不良反应方面存在差异,且均与标准疗法进行过比较,缺乏头对头研究的数据:方法:检索了经NMPA批准的中国晚期LC的表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKIs)、ALK-TKIs和ICIs的主要RCT,并将其分为五组。采用美国临床肿瘤学会价值框架(ASCO-VF v2)和欧洲肿瘤内科学会临床获益量表(ESMO-MCBS v1.1)评价RCT的净健康获益(NHB),包括疗效、不良反应和患者报告结局(PROs)等。比较了 ASCO-VF 和 ESMO-MCBS 的一致性:结果:截至 2024 年 9 月,ASCO-VF 和 ESMO-MCBS 共纳入了 37 项 RCT。NHB评分从12.30分到93.25分不等。19项试验达到了ASCO-VF的 "实质性获益 "标准,28项试验达到了ESMO-MCBS的 "实质性获益 "标准。除了icotinib、dacomitinib和befotertinib外,所有EGFR-TKIs和ALK-TKIs都达到了两个框架的阈值。在 ICI 方案中,有 8 项方案达到了两个框架所定义的 "实质性获益 "阈值,有 9 项研究显示了相互矛盾的结果。晚期LC研究中37对评分的相关系数估计为0.473(Spearman),一致性分析表明一致性尚可(κ = 0.265, p = 0.001):ASCO-VF和ESMO-MCBS关注临床疗效,并考虑了药物的不良反应和PROs。我们期待对不同的治疗方案进行头对头研究,并主张完善ESMO-MCBS。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Lung Cancer
Lung Cancer 医学-呼吸系统
CiteScore
9.40
自引率
3.80%
发文量
407
审稿时长
25 days
期刊介绍: Lung Cancer is an international publication covering the clinical, translational and basic science of malignancies of the lung and chest region.Original research articles, early reports, review articles, editorials and correspondence covering the prevention, epidemiology and etiology, basic biology, pathology, clinical assessment, surgery, chemotherapy, radiotherapy, combined treatment modalities, other treatment modalities and outcomes of lung cancer are welcome.
期刊最新文献
Clinical benefit evaluation of drug treatment regimens for advanced lung cancer:based on ASCO-VF and ESMO-MCBS Corrigendum to "Real-world treatment sequencing and effectiveness of second- and third-generation ALK tyrosine kinase inhibitors for ALK -positive advanced non-small cell lung cancer" [Lung Cancer 195 (2024) 107919]. Real-world comparison of the efficacy and safety of atezolizumab versus durvalumab in extensive-stage small cell lung cancer Treatment with trimetazidine dihydrochloride and lung cancer survival: Implications on metabolic re-programming Putative mechanisms of primary resistance to EGFR-targeted therapies: A retrospective study
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