Cancer Pain and Palliative Medicine Service, Department of Medical Oncology, Shaare Zedek Medical Center, Jerusalem, Israel;.
Laboratory of Biostatistics, School of Health Sciences, National and Kapodistrian University of Athens & Frontier Science Foundation-Hellas, Athens, Greece.
Ann Oncol. 2017 Oct 1;28(10):2340-2366. doi: 10.1093/annonc/mdx310.
The ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) version 1.0 (v1.0) was published in May 2015 and was the first version of a validated and reproducible tool to assess the magnitude of clinical benefit from new cancer therapies. The ESMO-MCBS was designed to be a dynamic tool with planned revisions and updates based upon recognition of expanding needs and shortcomings identified since the last review.
The revision process for the ESMO-MCBS incorporates a nine-step process: Careful review of critiques and suggestions, and identification of problems in the application of v1.0; Identification of shortcomings for revision in the upcoming version; Proposal and evaluation of solutions to address identified shortcomings; Field testing of solutions; Preparation of a near-final revised version for peer review for reasonableness by members of the ESMO Faculty and Guidelines Committee; Amendments based on peer review for reasonableness; Near-final review by members of the ESMO-MCBS Working Group and the ESMO Executive Board; Final amendments; Final review and approval by members of the ESMO-MCBS Working Group and the ESMO Executive Board.
Twelve issues for revision or amendment were proposed for consideration; proposed amendments were formulated for eight identified shortcomings. The proposed amendments are classified as either structural, technical, immunotherapy triggered or nuanced. All amendments were field tested in a wide range of studies comparing scores generated with ESMO-MCBS v1.0 and version 1.1 (v1.1).
ESMO-MCBS v1.1 incorporates 10 revisions and will allow for scoring of single-arm studies. Scoring remains very stable; revisions in v1.1 alter the scores of only 12 out of 118 comparative studies and facilitate scoring for single-arm studies.
ESMO 临床受益度量量表（ESMO-MCBS）版本 1.0（v1.0）于 2015 年 5 月发布，是首个经过验证和可重复使用的工具，用于评估新癌症疗法的临床受益程度。ESMO-MCBS 的设计是一个动态工具，计划根据上次审查以来认识到的扩展需求和发现的缺陷进行修订和更新。
ESMO-MCBS 的修订过程包括九个步骤：仔细审查批评和建议，并确定 v1.0 应用中的问题；确定即将发布的版本中需要修订的缺陷；提出并评估解决已确定缺陷的方案；对解决方案进行现场测试；为 ESMO 教师和指南委员会成员进行同行评审准备近乎最终修订版本，以评估合理性；根据同行评审的合理性进行修订；由 ESMO-MCBS 工作组和 ESMO 执行委员会成员进行最终审查；最终修正案；ESMO-MCBS 工作组和 ESMO 执行委员会成员的最终审查和批准。
提出了 12 个修订或修正的问题供考虑；为确定的 8 个缺陷提出了修正建议。拟议的修正案分为结构、技术、免疫治疗触发或细微差别。所有修正案都在广泛的研究中进行了现场测试，比较了使用 ESMO-MCBS v1.0 和版本 1.1（v1.1）生成的分数。
ESMO-MCBS v1.1 包含 10 项修订，将允许对单臂研究进行评分。评分仍然非常稳定；v1.1 中的修订仅改变了 118 项比较研究中的 12 项评分，并为单臂研究的评分提供了便利。
