Abstract
BACKGROUND: The PEGASUS trial was the first study to evaluate and demonstrate the benefits of (68)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). METHODS: 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. RESULTS: 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. CONCLUSION: 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.