ESMO-Magnitude of Clinical Benefit Scale version 2.0 (ESMO-MCBS v2.0).

IF 56.7 1区医学 Q1 ONCOLOGY

Annals of Oncology Pub Date : 2025-05-21 DOI:10.1016/j.annonc.2025.04.006

N I Cherny, S F Oosting, U Dafni, N J Latino, M Galotti, P Zygoura, G Dimopoulou, T Amaral, J Barriuso, A Calles, B Kiesewetter, C Gomez-Roca, B Gyawali, M Piccart, A Passaro, F Roitberg, N Tarazona, D Trapani, G Curigliano, R Wester, G Zarkavelis, C Zielinski, E G E de Vries

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引用次数: 0

Abstract

Background: The ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) is a validated tool to assess the magnitude of clinical benefit from new cancer therapies, with planned updates based upon recognition of new needs and shortcomings. This paper describes the development of ESMO-MCBS v2.0.

Methodology: The revision process incorporates nine steps: (i) review of critiques and suggestions and identification of problems in the application of ESMO-MCBS v1.1; (ii) identification of shortcomings for revision in the upcoming version; (iii) drafting solutions addressing identified shortcomings; (iv) field-testing of solutions; (v) preparation of a near-final revised version for peer review for reasonableness by members of the ESMO Faculty and ESMO Guidelines Committee; (vi) amendments based on peer review for reasonableness; (vii) near-final review by members of the ESMO-MCBS Working Group; (viii) final amendments; (ix) final review and approval by members of the ESMO-MCBS Working Group and the ESMO Executive Board.

Results: Seventeen issues for revision or amendment were considered, and 13 amendments were formulated to address identified shortcomings. In the curative setting, studies evaluated based on disease-free survival now credit improved time without treatment or disease even when overall survival is not significantly improved, and studies with small absolute gain in disease-free survival are credited more conservatively. Additionally, acute and persistent toxicity annotations are added. In the non-curative setting, the approach to crediting a difference in the tail of overall survival and progression-free survival curves is more statistically valid, and the toxicity evaluation has been revised. In peer review all amendments were found to be either reasonable or mostly reasonable. The amendments changed the scoring of 85/353 of evaluated studies.

Conclusions: The amendments incorporated into ESMO-MCBS v2.0 change the scores of 13.6% of evaluated studies (10.5% downgraded, 3.1% upgraded) and add toxicity annotations to 45.5% of the studies in the curative setting, and improve its discriminatory capacity and utility.

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esmo -临床获益程度量表2.0版（ESMO-MCBS 2.0版）。

背景：esmo -临床获益程度量表（ESMO-MCBS）是一种经过验证的工具，用于评估新的癌症治疗的临床获益程度，并根据新的需求和不足进行计划更新。本文介绍了ESMO-MCBS v2.0的开发过程。方法：修订过程包括九个步骤：(i)审查ESMO-MCBS v1.1应用中的批评和建议，并确定问题；（ii）在即将发布的版本中找出需要修改的缺点；起草解决已查明缺点的办法；实地测试解决方案；(v)为ESMO教员和ESMO指南委员会成员的合理性编写一份接近最终的修订本供同行评审；（六）经同行评议合理修改；ESMO-MCBS工作组成员的接近最后审查；（viii）最后修订；（ix） ESMO- mcbs工作组成员和ESMO执行局成员的最终审查和批准。结果：考虑了17个修订或修改的问题，并制定了13个修正案以解决已发现的不足。在治疗方面，基于无病生存期评估的研究，即使在总体生存期没有显著改善的情况下，也会将无病生存期的改善时间归功于无治疗或疾病的改善时间，而对无病生存期的绝对增加较小的研究则更保守地归功于无病生存期。此外，还添加了急性和持久性毒性注释。在非治愈情况下，总生存期和无进展生存期曲线尾部差异的计算方法在统计上更有效，毒性评估也得到了修订。在同行评议中，所有的修改被认为是合理的或大部分是合理的。修订改变了85/353的评估研究评分。结论：纳入ESMO-MCBS v2.0的修订改变了13.6%的评估研究的评分（10.5%降级，3.1%升级），并在治疗环境中为45.5%的研究增加了毒性注释，并提高了其区分能力和实用性。

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

Annals of Oncology 医学-肿瘤学

CiteScore

63.90

自引率

1.00%

发文量

3712

审稿时长

2-3 weeks

期刊介绍： Annals of Oncology, the official journal of the European Society for Medical Oncology and the Japanese Society of Medical Oncology, offers rapid and efficient peer-reviewed publications on innovative cancer treatments and translational research in oncology and precision medicine. The journal primarily focuses on areas such as systemic anticancer therapy, with a specific emphasis on molecular targeted agents and new immune therapies. We also welcome randomized trials, including negative results, as well as top-level guidelines. Additionally, we encourage submissions in emerging fields that are crucial to personalized medicine, such as molecular pathology, bioinformatics, modern statistics, and biotechnologies. Manuscripts related to radiotherapy, surgery, and pediatrics will be considered if they demonstrate a clear interaction with any of the aforementioned fields or if they present groundbreaking findings. Our international editorial board comprises renowned experts who are leaders in their respective fields. Through Annals of Oncology, we strive to provide the most effective communication on the dynamic and ever-evolving global oncology landscape.