{"title":"Abstract LB-163: Comparing clinical value scores (NCCN, ASCO and ESMO) for TTFields treatment in glioblastoma","authors":"J. Kelly, C. Proescholdt, N. Blondin","doi":"10.1158/1538-7445.AM2019-LB-163","DOIUrl":null,"url":null,"abstract":"Objective: To compare the tools of the National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) for the assessment of the clinical value for Tumor treating fields (TTFields) in newly diagnosed Glioblastoma (GBM). Background: The effectiveness and safety of TTFields in newly diagnosed GBM was demonstrated by the final analysis of the randomized controlled EF-14 Trial (n=695). NCCN, ASCO and ESMO have developed tools to help inform physicians and policymakers about the clinical value of new cancer treatments in a standardized way. We report on the results of the tools for scoring the EF-14 trial data and comparatively discuss the results. Materials/Methods: The EF-14 Trial proved the effect of adding TTFields to maintenance temozolomide (TMZ) for newly diagnosed glioblastoma patients. The ESMO Magnitude of Clinical Benefit Scale (MCBS) and the ASCO Net Health Benefit (NHB) frameworks calculate a score for the clinical value of a cancer treatment. We applied both classifications to the EF-14 trial data. Quality of life data from the EF-14 Trial was also published and is included in the scoring. NCCN self reports “evidence blocks” which are assessed by clinician panels and were recently published for the first line treatment of newly diagnosed GBM. Results: Applying the ASCO framework to the EF-14 data resulted in a NHB score of 56. This scores is among the highest identified in the literature search. Applying the ESMO framework resulted in MCBS scores of A/5, these being the highest achievable scores for this framework. The ESMO framework valued the Health Related Quality of Life (HRQoL) gain during deterioration-free survival time with TTFields. The NCCN CNS panel designated TTFields as a category 1 recommendation in newly diagnosed GBM; the related NCCN evidence blocks support this recommendation. Conclusions: While the frameworks used by ASCO and ESMO focus on different aspects and definition of clinical value both suggest that adding TTFields to maintenance TMZ for newly diagnosed glioblastoma patients provides patients with significant clinical benefits. The high ESMO and ASCO scores are reflecting the fact, that treatment with TTFields extended progression free and overall survival without additional systemic toxicities. The NCCN evidence blocks together with the NCCN category 1 recommendation strongly support the use of Optune in newly diagnosed GBM Citation Format: Justin Kelly, Christina Proescholdt, Nicholas A. Blondin. Comparing clinical value scores (NCCN, ASCO and ESMO) for TTFields treatment in glioblastoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr LB-163.","PeriodicalId":21579,"journal":{"name":"Science and Health Policy","volume":"33 1 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2019-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Science and Health Policy","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1158/1538-7445.AM2019-LB-163","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Objective: To compare the tools of the National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) for the assessment of the clinical value for Tumor treating fields (TTFields) in newly diagnosed Glioblastoma (GBM). Background: The effectiveness and safety of TTFields in newly diagnosed GBM was demonstrated by the final analysis of the randomized controlled EF-14 Trial (n=695). NCCN, ASCO and ESMO have developed tools to help inform physicians and policymakers about the clinical value of new cancer treatments in a standardized way. We report on the results of the tools for scoring the EF-14 trial data and comparatively discuss the results. Materials/Methods: The EF-14 Trial proved the effect of adding TTFields to maintenance temozolomide (TMZ) for newly diagnosed glioblastoma patients. The ESMO Magnitude of Clinical Benefit Scale (MCBS) and the ASCO Net Health Benefit (NHB) frameworks calculate a score for the clinical value of a cancer treatment. We applied both classifications to the EF-14 trial data. Quality of life data from the EF-14 Trial was also published and is included in the scoring. NCCN self reports “evidence blocks” which are assessed by clinician panels and were recently published for the first line treatment of newly diagnosed GBM. Results: Applying the ASCO framework to the EF-14 data resulted in a NHB score of 56. This scores is among the highest identified in the literature search. Applying the ESMO framework resulted in MCBS scores of A/5, these being the highest achievable scores for this framework. The ESMO framework valued the Health Related Quality of Life (HRQoL) gain during deterioration-free survival time with TTFields. The NCCN CNS panel designated TTFields as a category 1 recommendation in newly diagnosed GBM; the related NCCN evidence blocks support this recommendation. Conclusions: While the frameworks used by ASCO and ESMO focus on different aspects and definition of clinical value both suggest that adding TTFields to maintenance TMZ for newly diagnosed glioblastoma patients provides patients with significant clinical benefits. The high ESMO and ASCO scores are reflecting the fact, that treatment with TTFields extended progression free and overall survival without additional systemic toxicities. The NCCN evidence blocks together with the NCCN category 1 recommendation strongly support the use of Optune in newly diagnosed GBM Citation Format: Justin Kelly, Christina Proescholdt, Nicholas A. Blondin. Comparing clinical value scores (NCCN, ASCO and ESMO) for TTFields treatment in glioblastoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr LB-163.
目的:比较美国国家综合肿瘤网络(NCCN)、美国临床肿瘤学会(ASCO)和欧洲肿瘤医学学会(ESMO)的工具对新诊断的胶质母细胞瘤(GBM)的肿瘤治疗场(TTFields)的临床价值评估。背景:随机对照EF-14试验(n=695)的最终分析证明了TTFields治疗新诊断的GBM的有效性和安全性。NCCN、ASCO和ESMO开发了工具,帮助医生和决策者以标准化的方式了解新的癌症治疗方法的临床价值。报告了EF-14试验数据评分工具的结果,并对结果进行了比较讨论。材料/方法:EF-14试验证实了在替莫唑胺(TMZ)维持治疗中加入TTFields对新诊断的胶质母细胞瘤患者的效果。ESMO临床获益量表(MCBS)和ASCO净健康获益(NHB)框架计算癌症治疗的临床价值得分。我们将这两种分类应用于EF-14试验数据。来自EF-14试验的生活质量数据也被公布,并被纳入评分。NCCN自我报告“证据块”,由临床医生小组评估,并于最近发表,用于新诊断的GBM的一线治疗。结果:将ASCO框架应用于EF-14数据,NHB得分为56分。这个分数是在文献检索中发现的最高分数之一。应用ESMO框架,MCBS得分为A/5,这是该框架可达到的最高分数。ESMO框架评估了TTFields在无恶化生存期间获得的健康相关生活质量(HRQoL)。NCCN CNS专家组将TTFields指定为新诊断的GBM的1类推荐;相关的NCCN证据块支持这一建议。结论:虽然ASCO和ESMO采用的框架侧重于不同的方面和临床价值的定义,但都表明,在新诊断的胶质母细胞瘤患者中加入TTFields来维持TMZ可以为患者提供显着的临床益处。高ESMO和ASCO评分反映了这样一个事实,即TTFields治疗延长了无进展和总生存期,没有额外的全身毒性。NCCN证据块以及NCCN第一类推荐强烈支持在新诊断的GBM引文格式中使用Optune: Justin Kelly, Christina Proescholdt, Nicholas A. Blondin。比较TTFields治疗胶质母细胞瘤的临床价值评分(NCCN、ASCO和ESMO)[摘要]。摘自:2019年美国癌症研究协会年会论文集;2019年3月29日至4月3日;亚特兰大,乔治亚州。费城(PA): AACR;癌症杂志,2019;79(13增刊):摘要nr LB-163。