Lucia François, Lamour Jacques, Geier Margaux, Bourbonne Vincent, Pinot Fanny, Nebbache Malik, Blanc-Béguin Frédérique, Hennebicq Simon, Mauguen Maëlle, Kerleguer Kevin, Schick Ulrike, Pradier Olivier, Le Gal Grégoire, Salaun Pierre-Yves, Bourhis David, Le Roux Pierre-Yves
Radiation Oncology Department, University Hospital, Brest, France.
LaTIM INSERM, UMR 1101, University of Brest, Brest, 29200, France.
Radiat Oncol. 2025 Jul 9;20(1):108. doi: 10.1186/s13014-025-02685-w.
The PEGASUS trial was the first study to evaluate and demonstrate the benefits of Ga-perfusion PET/CT in the lung stereotactic body radiotherapy (SBRT) planning process in preserving functional lung volumes while respecting target volume coverage and doses to other organs at risk. Here we report the prespecified exploratory endpoint of SBRT on health-related quality of life (HRQoL).
In this single-center prospective study, we recruited patients planned to be treated in our radiotherapy department with SBRT for primary or secondary lung tumors. Patient-reported outcomes were assessed at the first visit, 1 month, 3 months and every 3 months until 12 months after SBRT using the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 items (QLQ-C30), the EORTC Quality of Life Questionnaire Lung Cancer 13 items (QLQ-LC13), and the European Quality of Life 5 Dimensions-5 Level (EQ-5D-5 L) questionnaire. The key exploratory HRQoL endpoints (analyzed for all patients who completed at least QLQ-C30 at least one time point after SBRT) were baseline-to-early change (between 1 month and 3 month) and baseline-to-late change (between 6 month and 12 month) in the QLQ-C30 global health status (GHS)/quality-of-life (QoL) score and in the deterioration of the dyspnea (patient-reported lung toxicity). Explorative analysis of the impact of baseline HRQoL, patient- and SBRT-related characteristics, including PET perfusion-based functional parameters, on the change in HRQoL from baseline was analyzed using univariate analysis.
Of the 60 patients included, 39 were analyzable as early-onset and 22 as late-onset. Thirteen (33%) and 7 (32%) patients had a deterioration of QoL. In univariate analysis, maximal dose to the heart, doses to the functional lung volume and pulmonary functional test parameters were significantly associated with the early deterioration of HRQoL. Only doses to the functional lung volume were significantly associated with the late deterioration of HRQoL.
In our study, increased radiation doses in functional lung volume PET bases dose parameters were significantly associated with a decrease of HRQoL unlike anatomic lung parameters. Functional lung avoidance planning guided by perfusion PET/CT may be a simple and noninvasive method to improve HRQoL in patients treated with lung SBRT.
PEGASUS试验是第一项评估并证明在肺部立体定向体部放疗（SBRT）计划过程中，镓灌注PET/CT在保留功能性肺体积的同时，兼顾靶区覆盖及对其他危及器官的剂量方面的益处的研究。在此，我们报告SBRT对健康相关生活质量（HRQoL）的预设探索性终点。
在这项单中心前瞻性研究中，我们招募了计划在我们放疗科接受SBRT治疗原发性或继发性肺部肿瘤的患者。在首次就诊时、1个月、3个月以及SBRT后直至12个月期间，每3个月使用欧洲癌症研究与治疗组织（EORTC）生活质量问卷核心30项（QLQ-C30）、EORTC肺癌生活质量问卷13项（QLQ-LC13）以及欧洲生活质量5维度-5水平（EQ-5D-5L）问卷评估患者报告的结局。关键的探索性HRQoL终点（针对所有在SBRT后至少一个时间点完成至少QLQ-C30的患者进行分析）为QLQ-C30总体健康状况（GHS）/生活质量（QoL）评分以及呼吸困难恶化（患者报告的肺部毒性）方面的基线至早期变化（1个月至3个月之间）和基线至晚期变化（6个月至12个月之间）。使用单因素分析对基线HRQoL、患者及SBRT相关特征（包括基于PET灌注的功能参数）对HRQoL自基线变化的影响进行探索性分析。
纳入的60例患者中，39例可作为早期发病进行分析，22例作为晚期发病进行分析。13例（33%）和7例（32%）患者生活质量恶化。在单因素分析中，心脏最大剂量、功能性肺体积剂量以及肺功能测试参数与HRQoL早期恶化显著相关。只有功能性肺体积剂量与HRQoL晚期恶化显著相关。
在我们的研究中，与解剖学肺参数不同，功能性肺体积PET基础剂量参数中辐射剂量增加与HRQoL降低显著相关。由灌注PET/CT引导的功能性肺规避计划可能是一种改善接受肺部SBRT治疗患者HRQoL的简单且非侵入性的方法。
