荷兰食管癌患者质子放疗的国家指征方案。

IF 5.3 1区医学 Q1 ONCOLOGY

Radiotherapy and Oncology Pub Date : 2025-09-24 DOI:10.1016/j.radonc.2025.111164

Christina T Muijs , Yvonne L.B. Klaver , Joost Nuyttens , Irene M Lips , Karin Muller , Gati Mulder- Ebrahimi , Frank J.W.M. Dankers , Rob Verhoeven , Ewoud Schuit , Maaike Berbee

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引用次数: 0

摘要

背景：放化疗（CRT）在治疗食管癌（EC）中起着关键作用，但与显著的毒性相关。质子放疗（PRT）可以通过限制对危险器官的辐射剂量来降低这种风险。在荷兰，PRT只有在符合质子治疗国家适应症方案（NIPP）中定义的资格标准时才可以报销。本研究描述了基于模型选择的电子商务协议的开发和实现。材料和方法：成立了一个国家多学科工作组，旨在通过文献综述、预测模型评估、外部模型验证和利益相关者参与来制定NIPP协议。结果：心脏事件和总生存期被确定为最具临床相关性的终点。由于没有现有的模型满足基于模型的选择的质量标准，最初为肺癌开发的经过验证的2年死亡率预测模型在接受决定性（dCRT）或新辅助（nCRT） CRT治疗的EC患者中进行了外部验证。在更新截距（两个队列）和斜率（nCRT）后，模型表现良好。基于模型的选择被定义为 ≥ 5 %预测PRT与光子放疗的2年死亡率绝对降低，使用平均心脏剂量（MHD）和总肿瘤体积（GTV）作为预测因子。其他选择标准包括WHO表现状态0-2和排除cT4、cN3或cM1状态。荷兰放射肿瘤学学会于2021年6月批准了NIPP，荷兰卫生保健研究所于2021年10月批准了NIPP。国家实施和预期结果评估正在通过ProTRAIT登记处进行。结论：荷兰成功实施了一项基于模型的EC PRT国家适应证方案。NIPP描述了质子治疗报销的资格标准，并允许报销预期从PRT获益的个体患者。

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National indication protocol for proton radiotherapy in esophageal cancer patients in the Netherlands

Background

Chemoradiotherapy (CRT) plays a key role in treating esophageal cancer (EC) but is associated with significant toxicity. Proton radiotherapy (PRT) may reduce this risk by limiting radiation dose to organs at risk. In the Netherlands, PRT is reimbursed only when eligibility criteria defined in a National Indication Protocol for Proton Therapy (NIPP) are met. This study describes the development and implementation of such a protocol for EC based on model-based selection.

Materials and Methods

A national multidisciplinary working group was formed aiming to develop the NIPP protocol through literature review, evaluation of prediction models, external model validation, and stakeholder engagement.

Results

Cardiac events and overall survival were identified as the most clinically relevant endpoints. As no existing models met the quality criteria for model-based selection, a validated 2-year mortality prediction model originally developed for lung cancer was externally validated in EC patients treated with definitive (dCRT) or neoadjuvant (nCRT) CRT. The model performed well after updates to the intercept (both cohorts) and slope (nCRT). Model-based selection was defined as a ≥ 5 % predicted absolute reduction in 2-year mortality with PRT versus photon radiotherapy, using Mean Heart Dose (MHD) and Gross Tumor Volume (GTV) as predictors. Additional selection criteria included WHO performance status 0–2 and exclusion of cT4, cN3, or cM1 status. The NIPP was approved by the Dutch Society of Radiation Oncology in June 2021 and by the Dutch Health Care Institute in October 2021. National implementation and prospective outcome evaluation are ongoing via the ProTRAIT registry.

Conclusion

A national indication protocol enabling model-based selection for PRT in EC was successfully implemented in the Netherlands. The NIPP describes eligibility criteria for proton therapy reimbursement and enables reimbursement for individual patients who are expected to benefit from PRT.

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来源期刊

Radiotherapy and Oncology 医学-核医学

CiteScore

10.30

自引率

10.50%

发文量

2445

审稿时长

45 days

期刊介绍： Radiotherapy and Oncology publishes papers describing original research as well as review articles. It covers areas of interest relating to radiation oncology. This includes: clinical radiotherapy, combined modality treatment, translational studies, epidemiological outcomes, imaging, dosimetry, and radiation therapy planning, experimental work in radiobiology, chemobiology, hyperthermia and tumour biology, as well as data science in radiation oncology and physics aspects relevant to oncology.Papers on more general aspects of interest to the radiation oncologist including chemotherapy, surgery and immunology are also published.