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下一代测序对法国肿瘤学临床实践的影响:更好的遗传谱可提高患者获得实验性治疗的机会。

Impact of Next Generation Sequencing on Clinical Practice in Oncology in France: Better Genetic Profiles for Patients Improve Access to Experimental Treatments.

机构信息

Unité de Recherche Clinique en Économie de la Santé d'Ile de France, Assistance Publique Hôpitaux de Paris, Paris, France; Université Paris Diderot, Sorbonne Paris Cité, Paris, France; Centre of Research in Epidemiology and Statistics, Institut National de la Santé et de la Recherche Médicale-Joint Research Units, Paris, France.

Unité de Recherche Clinique en Économie de la Santé d'Ile de France, Assistance Publique Hôpitaux de Paris, Paris, France.

出版信息

Value Health. 2020 Jul;23(7):898-906. doi: 10.1016/j.jval.2020.03.005. Epub 2020 Jul 18.

Abstract

OBJECTIVES

We evaluated how next generation sequencing (NGS) can modify care pathways in an observational impact study in France.

METHODS

All patients with lung cancer, colorectal cancer, or melanoma who had NGS analyses of somatic genomic alterations done in 1 of 7 biomolecular platforms certified by the French National Cancer Institute (INCa) between 2013 and 2016 were eligible. We compared patients' pathways before and after their NGS results. Endpoints consisted of the turnaround time in obtaining results, the number of patients with at least 1 genomic alteration identified, the number of actionable alterations, the impact of the genomic multidisciplinary tumor board on care pathways, the number of changes in the treatment plan, and the survival outcome up to 1 year after NGS analyses.

RESULTS

1213 patients with a request for NGS analysis were included. NGS was performed for 1155 patients, identified at least 1 genomic alteration for 867 (75%), and provided an actionable alteration for 614 (53%). Turnaround time between analyses and results was on average 8 days (Min: 0; Max: 95) for all cancer types. Before NGS analysis, 33 of 614 patients (5%) were prescribed a targeted therapy compared with 54 of 614 patients (8%) after NGS analysis. Proposition of inclusion in clinical trials with experimental treatments increased from 5% (n = 31 of 614) before to 28% (n = 178 of 614) after NGS analysis. Patients who benefited from a genotype matched treatment after NGS analysis tended to have a better survival outcome at 1 year than patients with nonmatched treatment: 258 days (±107) compared with 234 days (±106), (P = .41).

CONCLUSIONS

NGS analyses resulted in a change in patients' care pathways for 20% of patients (n = 232 of 1155).

摘要

目的

我们评估了下一代测序(NGS)如何在法国的一项观察性影响研究中改变护理路径。

方法

所有在 2013 年至 2016 年间在法国国家癌症研究所(INCa)认证的 7 个生物分子平台之一进行体细胞基因组改变 NGS 分析的肺癌、结直肠癌或黑色素瘤患者均符合条件。我们比较了患者在获得 NGS 结果前后的路径。终点包括获得结果的周转时间、确定至少 1 个基因组改变的患者数量、可操作改变的数量、基因组多学科肿瘤委员会对护理路径的影响、治疗计划的变化数量以及 NGS 分析后 1 年内的生存结果。

结果

纳入了 1213 名有 NGS 分析请求的患者。对 1155 名患者进行了 NGS 检测,其中 867 名(75%)患者确定了至少 1 个基因组改变,614 名(53%)患者提供了可操作改变。所有癌症类型的分析和结果之间的周转时间平均为 8 天(最小:0;最大:95)。在 NGS 分析之前,614 名患者中有 33 名(5%)接受了靶向治疗,而在 NGS 分析之后,614 名患者中有 54 名(8%)接受了靶向治疗。在 NGS 分析之前,5%(n=614 例中有 31 例)的患者被提议参加实验性治疗的临床试验,而在 NGS 分析之后,这一比例增加到 28%(n=614 例中有 178 例)。接受 NGS 分析后,受益于基因型匹配治疗的患者在 1 年时的生存结果往往好于接受非匹配治疗的患者:258 天(±107)与 234 天(±106),(P=0.41)。

结论

NGS 分析导致 20%(n=1155 例中有 232 例)患者的护理路径发生变化。

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