Shaare Zedek Medical Center, Jerusalem, Israel.
University of Groningen, Groningen, the Netherlands.
J Clin Oncol. 2019 Feb 1;37(4):336-349. doi: 10.1200/JCO.18.00729. Epub 2018 Dec 17.
To better understand the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) and the ASCO Value Framework Net Health Benefit score version 2 (ASCO-NHB v2), ESMO and ASCO collaborated to evaluate the concordance between the frameworks when used to assess clinical benefit attributable to new therapies.
The 102 randomized controlled trials in the noncurative setting already evaluated in the field testing of ESMO-MCBS v1.1 were scored using ASCO-NHB v2 by its developers. Measures of agreement between the frameworks were calculated and receiver operating characteristic curves used to define thresholds for the ASCO-NHB v2 corresponding to ESMO-MCBS v1.1 categories. Studies with discordant scoring were identified and evaluated to understand the reasons for discordance.
The correlation of the 102 pairs of scores for studies in the noncurative setting is estimated to be 0.68 (Spearman's rank correlation coefficient; overall survival, 0.71; progression-free survival, 0.67). Receiver operating characteristic curves identified thresholds for ASCO-NHB v2 for facilitating comparisons with ESMO-MCBS v1.1 categories. After applying pragmatic threshold scores of 40 or less (ASCO-NHB v2) and 2 or less (ESMO-MCBS v1.1) for low benefit and 45 or greater (ASCO-NHB v2) and 4 to 5 (ESMO-MCBS v1.1) for substantial benefit, 37 discordant studies were identified. Major factors that contributed to discordance were different approaches to evaluation of relative and absolute gain for overall survival and progression-free survival, crediting tail of the curve gains, and assessing toxicity.
The agreement between the frameworks was higher than observed in other studies that sought to compare them. The factors that contributed to discordant scores suggest potential approaches to improve convergence between the scales.
为了更好地理解欧洲肿瘤内科学会-临床获益量表 1.1 版(ESMO-MCBS v1.1)和美国临床肿瘤学会-价值框架净健康获益评分 2 版(ASCO-NHB v2),欧洲肿瘤内科学会和美国临床肿瘤学会合作评估这两个框架在评估新疗法归因于临床获益时的一致性。
使用 ASCO-NHB v2 对 ESMO-MCBS v1.1 现场测试中已经评估的 102 项非治愈性环境下的随机对照试验进行评分,由其开发者完成。计算了两个框架之间的一致性度量,并使用受试者工作特征曲线来定义 ASCO-NHB v2 与 ESMO-MCBS v1.1 类别对应的阈值。确定了具有不同评分的研究,并对其进行了评估,以了解产生差异的原因。
非治愈性环境下的 102 项研究评分的相关性估计为 0.68(Spearman 等级相关系数;总生存为 0.71;无进展生存为 0.67)。受试者工作特征曲线确定了 ASCO-NHB v2 的阈值,以便与 ESMO-MCBS v1.1 类别进行比较。应用实用的阈值评分(ASCO-NHB v2 为 40 或以下,ESMO-MCBS v1.1 为 2 或以下)表示低获益和 ASCO-NHB v2 为 45 或以上,ESMO-MCBS v1.1 为 4 至 5 表示高获益,有 37 项研究被确定为存在差异。导致差异的主要因素是评估总生存和无进展生存的相对和绝对获益的方法不同、认可曲线尾部的获益以及评估毒性。
两个框架之间的一致性高于其他试图对其进行比较的研究中观察到的一致性。导致评分差异的因素表明了改善这些量表之间收敛性的潜在方法。