Department of Radiation Oncology, University of Virginia, Charlottesville, Virginia, USA.
School of Public Health Sciences, Division of Biostatistics, University of Virginia, Charlottesville, Virginia, USA.
Brachytherapy. 2024 May-Jun;23(3):248-256. doi: 10.1016/j.brachy.2024.02.004. Epub 2024 Mar 21.
The purpose of this prospective randomized trial was to compare the use of a novel vaginal hydrogel packing system (BrachyGel) to standard vaginal packing (VP) during high dose rate (HDR) brachytherapy (BT) for locally advanced cervical cancer (LACC).
This cross-over study included LACC patients receiving HDR BT boost (intracavitary +/- interstitial). All patients received alternating gauze or BrachyGel VP on Arms A and B. Patients, physicians, and physicists evaluated BT characteristics via a 4-point Likert scale. Adverse events (AEs) were prospectively collected and scored per CTCAE.
The 20 patients enrolled. The mean bladder D2cc difference between gauze and BrachyGel in Arm A was 0.117 Gray (Gy) and in Arm B 0.013 Gy. The mean difference in rectum D2cc in Arm A and Arm B was -0.189 Gy and -0.191 Gy, respectively. The mean dose to 90% of the high-risk clinical target volume (HR-CTV) for gauze compared to BrachyGel was -0.032 Gy (95% CI: 0.472, 0.409). Patient-reported discomfort was similar with BrachyGel and gauze ("mild/moderate" 70.0% vs 74.0%, respectively). The clarity of VP was similar between BrachyGel and gauze (86.8% vs 89.7%, respectively). The completeness of VP was more frequently "excellent/good" with BrachyGel (79.0%) compared to gauze (56.4%). The ease of packing was more frequently "extremely easy" with BrachyGel (21.2% vs 0%). No serious AEs were reported.
This randomized trial found no clinically significant difference in OAR or HR-CTV dosimetry between BrachyGel and standard VP. BrachyGel performed well compared to gauze for the patient and physician use experience.
本前瞻性随机试验的目的是比较新型阴道水凝胶填塞系统（BrachyGel）与标准阴道填塞（VP）在局部晚期宫颈癌（LACC）高剂量率（HDR）近距离放疗（BT）中的应用。
本交叉研究纳入接受 HDR BT 推量（腔内 +/- 间质内）的 LACC 患者。所有患者在 A 臂和 B 臂分别接受交替使用纱布或 BrachyGel VP。患者、医生和物理学家通过 4 分李克特量表评估 BT 特征。前瞻性收集不良反应（AE）并按 CTCAE 评分。
共纳入 20 例患者。A 臂中纱布与 BrachyGel 之间膀胱 D2cc 的平均差异为 0.117 Gray（Gy），B 臂中为 0.013 Gy。A 臂和 B 臂直肠 D2cc 的平均差异分别为-0.189 Gy 和-0.191 Gy。与纱布相比，BrachyGel 用于 90%高危临床靶区（HR-CTV）的平均剂量为-0.032 Gy（95%CI：0.472，0.409）。BrachyGel 和纱布的患者报告不适程度相似（分别为“轻度/中度”70.0%和 74.0%）。VP 的清晰度在 BrachyGel 和纱布之间相似（分别为 86.8%和 89.7%）。VP 的完整性更频繁地“极好/好”用 BrachyGel（79.0%），而纱布为 56.4%（P<0.001）。BrachyGel 的包装更容易“极其容易”（21.2%对 0%）。未报告严重 AE。
本随机试验未发现 BrachyGel 和标准 VP 之间 OAR 或 HR-CTV 剂量学有临床意义的差异。与纱布相比，BrachyGel 在患者和医生使用体验方面表现良好。
