Living in a material world: tumor-treating fields at the top of the charts.
Living in a material world: tumor-treating fields at the top of the charts.
复制标题
生活在物质世界：肿瘤治疗领域名列前茅。
DOI：
10.1093/neuonc/now138
复制
发表时间：
2016
期刊：
影响因子：
15.9
通讯作者：
Schrag,Deborah
中科院分区：
文献类型：
--
作者：
Schiff,David;Schrag,Deborah
低强度，中频交变电场（肿瘤治疗场，或TTFields [Optune， Novocure]）在治疗胶质母细胞瘤中的潜在作用已经引起了兴奋，希望和争议。最初的细胞系和动物模型研究1,2很快转化为EF-11复发性胶质母细胞瘤的III期试验。EF-11证实了设备的安全性，并表明TTFields具有与二线和二线化疗相当的抗肿瘤活性，这一结果获得了FDA的批准，但对于一些神经肿瘤学家来说，鉴于复发性胶质母细胞瘤的化疗效果不佳，这一结果并不令人信服。EF-14出现了更强的结果，这是一项针对新诊断的胶质母细胞瘤的III期试验，该试验将治疗后TTFields联合替莫唑胺与单独替莫唑胺的患者随机分组。EF-14的中期分析显示，在意向治疗分析中，EF-14的总生存期优势为3.0个月（按方案子集为4.9个月），无进展生存期改善3.1个月。这些阳性结果是基于695名入组患者中的前315名；对整个队列的分析并没有实质性地改变结果。因此，2015年10月，FDA批准了TTFields在新诊断的胶质母细胞瘤中的使用。在本期《神经肿瘤学》杂志上，Bernard-Amoux及其同事报道了一项成本效益分析的结果，该分析评估了TTFields在法国医疗保健系统中治疗胶质母细胞瘤的增量效益。他们的主要发现是，TTFields与标准护理放化疗的结合使用，并不在大多数制定了明确阈值的监管机构所认为的“成本效益”范围之内。虽然法国没有使用明确的阈值，但拥有国家卫生系统的英联邦国家，如英国、澳大利亚、新西兰和加拿大，通常认为每生命年获得5万至10万美元的比率的治疗干预措施具有成本效益。在美国，监管机构禁止在决定覆盖范围时考虑成本，但非正式地，类似的阈值被用于将治疗标记为具有成本效益。6成本效益分析（如Bernard-Amoux等）是在比较两种备选策略的基础上确定的。在这种情况下，比较的是加TTFields的放化疗和标准放化疗。增量成本-效果比（ICER）计算了放化疗/TTFields相对于放化疗的成本，同时也评估了这些治疗的益处（以生存时间表示）。ICER是这些差异的比率。关于报告的分析，有几个方法学要点值得注意。首先，这是一个事后成本效益分析，完全依赖于已发表的试验报告。为什么这很重要？建模方法没有每个试验参与者的数据，因此没有计算每个人接受基于方案的治疗、无进展的治疗、二线治疗或临终关怀的精确时间。分析依赖于研究报告的平均差异来模拟这些参数。潜在的假设是，这种比较中的关键成本驱动因素来自治疗本身的成本。TTFields在商业环境中的巨大成本使得这个假设是合理的，尽管不确定。（在所有卫生系统中）卫生保健支出的一个主要来源是住院。一组患者的住院天数越多，相应的费用就越高。如果TTFields能延长患者的生存期，让胶质母细胞瘤患者远离医院…
The potential role of low-intensity, intermediate-frequency alternating electrical fields (tumor-treating fields, or TTFields [Optune, Novocure]) in treating glioblastoma has generated excitement, hope, and controversy. Initial cell line and animal model studies 1, 2 were quickly translated to the EF-11 Phase III trial in recurrent glioblastoma. EF-11 confirmed device safety and suggested that TTFields had antitumor activity comparable to second-and later-line chemotherapy, 3 a result leading to FDA approval but uncompelling to some neuro-oncologists given the poor results with chemotherapy for recurrent glioblastoma. Stronger results emerged from EF-14, a Phase III trial in newly diagnosed glioblastoma that randomized patients postradiation to TTFields plus temozolomide versus temozolomide alone. Interim analysis of EF-14 demonstrated a 3.0-month overall survival advantage in the intent-to-treat analysis (4.9 months in the per-protocol subset) and a 3.1-month improvement in progression-free survival. 4 These positive results were based upon the first 315 of 695 enrolled patients; analysis of the entire cohort did not substantially change the results. Consequently, in October 2015 the FDA approved the use of TTFields in newly diagnosed glioblastoma. In this issue of Neuro-Oncology, Bernard-Amoux and colleagues report on the results of a cost-effectiveness analysis evaluating the incremental benefit of TTFields for glioblastoma in the context of the French health care system. Their principal finding is that the use of TTFields in conjunction with standard of care chemoradiation is not within the realm of what is considered “cost-effective” by most regulatory bodies that have established explicit thresholds. While France does not use explicit thresholds, Commonwealth countries with national health systems, such as the UK, Australia, New Zealand, and Canada, generally consider treatment interventions that have ratios of $50 000–$100 000 per life-year gained to be cost-effective. 5 In the US, regulatory authorities are prohibited from considering cost in making decisions about coverage, but informally, similar thresholds are used to label treatments as cost-effective. 6 Cost-effectiveness analyses such as Bernard-Amoux et al’s are determined on the basis of comparing 2 alternative strategies. In this case, the comparison is between chemoradiation plus TTFields versus standard chemoradiation. The incremental cost-effectiveness ratio (ICER) computes the cost of chemoradiation/TTFields versus that of chemoradiation while also assessing the benefits (expressed in terms of survival time) for these treatments. The ICER is the ratio of these differences. Several methodological points are worth noting about the reported analysis. First, this was a post-hoc cost-effectiveness analysis that relied entirely on the published report of the trial. Why does this matter? The modeling approach does not have data for each trial participant and therefore does not calculate the precise amount of time that each individual spent receiving protocol-based treatment, no treatment without progression, second-line treatment, or palliative end-of-life care. The analysis relies on the study-reported average differences to model these parameters. The underlying assumption is that the key cost driver in this comparison stems from the costs of treatment itself. The huge cost of TTFields in the commercial setting makes this assumption reasonable, albeit uncertain. A major source of health care expenditures (in all health systems) is hospitalization. More hospitalization days in one group should correspond to higher costs. If TTFields prolong survival and keep glioblastoma patients out of the hospital …
卡莫司汀植入物治疗新诊断的高级别胶质瘤
影响因子：
4.4
作者：
Gabriel Rogers;R. Garside;S. Mealing;M. Pitt;Robert Anderson;M. Dyer;K. Stein;M. Somerville
通讯作者：
M. Somerville
DOI：
10.1586/14737167.8.2.165
发表时间：
2008-04-01
影响因子：
2.3
作者：
Grosse, Scott D
通讯作者：
Grosse, Scott D
影响因子：
15.9
作者：
Messali, Andrew;Hay, Joel W.;Villacorta, Reginald
通讯作者：
Villacorta, Reginald