Pelak Maciej J, Flechl Birgit, Hug Eugen, Galalae Razvan, Konrath Lisa, Góra Joanna, Fossati Piero, Lütgendorf-Caucig Carola, Tubin Slavisa, Konstantinovic Rastko, Mock Ulrike, Fussl Christoph, Georg Petra
MedAustron Ion Therapy Center, Wiener Neustadt, Austria.
Medizinische Fakultät, Christian-Albrechts-Universität zu Kiel, Kiel, Germany.
Front Oncol. 2022 Aug 16;12:962697. doi: 10.3389/fonc.2022.962697. eCollection 2022.
Data on the safety of moderately hypofractionated proton beam therapy (PBT) are limited. The aim of this study is to compare the acute toxicity and early quality of life (QoL) outcomes of normofractionated (nPBT) and hypofractionated PBT (hPBT).
We prospectively compared acute toxicity and QoL between patients treated with nPBT (dose per fraction 1.8-2.3 Gy, n = 90) and hPBT (dose per fraction 2.5-3.1 Gy, n = 49) in following locations: head and neck (H&N, n = 85), abdomen and pelvis (A&P, n = 43), and other soft tissue (ST, n = 11). The toxicities were grouped into categories-mucosal, skin, and other sites-and evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 at baseline, treatment completion, and 3 months after PBT completion. QoL was evaluated with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 scale for all locations and additionally with EORTC QLQ-HN35 for H&N patients.
Overall, the highest toxicity grades of G0, G1, G2, and G3 were observed in 7 (5%), 40 (28.8%), 78 (56.1%), and 15 (10.8%) patients, respectively. According to organ and site, no statistically significant differences were detected in the majority of toxicity comparisons (66.7%). For A&P, hPBT showed a more favorable toxicity profile as compared to nPBT with a higher frequency of G0 and G1 and a lower frequency of G2 and G3 events (p = 0.04), more patients with improvement (95.7% 70%, p = 0.023), and full resolution of toxicities (87% vs 50%, p = 0.008). Skin toxicity was unanimously milder for hPBT compared to nPBT in A&P and ST locations (p = 0.018 and p = 0.025, respectively). No significant differences in QoL were observed in 97% of comparisons for QLQ-C30 scale except for loss of appetite in H&N patients (+33.3 for nPBT and 0 for hPBT, p = 0.02) and role functioning for A&P patients (0 for nPBT +16.7 hPBT, p = 0.003). For QLQ-HN35, 97.9% of comparisons did not reveal significant differences, with pain as the only scale varying between the groups (-8.33 -25, p = 0.016).
Hypofractionated proton therapy offers non-inferior early safety and QoL as compared to normofractionated irradiation and warrants further clinical investigation.
关于中等分割质子束治疗（PBT）安全性的数据有限。本研究的目的是比较常规分割质子束治疗（nPBT）和低分割质子束治疗（hPBT）的急性毒性和早期生活质量（QoL）结果。
我们前瞻性地比较了接受nPBT（每分次剂量1.8 - 2.3 Gy，n = 90）和hPBT（每分次剂量2.5 - 3.1 Gy，n = 49）治疗的患者在以下部位的急性毒性和QoL：头颈部（H&N，n = 85）、腹部和盆腔（A&P，n = 43）以及其他软组织（ST，n = 11）。毒性分为黏膜、皮肤和其他部位三类，并根据不良事件通用术语标准（CTCAE）第4.03版在基线、治疗结束时以及PBT结束后3个月进行评估。使用欧洲癌症研究与治疗组织（EORTC）生活质量问卷（QLQ）-C30量表对所有部位的QoL进行评估，对于H&N患者还额外使用EORTC QLQ-HN35量表。
总体而言，分别有7例（5%）、40例（28.8%）、78例（56.1%）和15例（10.8%）患者观察到G0级、G1级、G2级和G3级的最高毒性等级。根据器官和部位，在大多数毒性比较中（66.7%）未检测到统计学显著差异。对于A&P，与nPBT相比，hPBT显示出更有利的毒性特征，G0级和G1级的频率更高，G2级和G3级事件的频率更低（p = 0.04），更多患者症状改善（95.7%对70%，p = 0.0
