Department of Radiation Oncology, Washington University in St. Louis, United States.
Department of Radiation Oncology, Washington University in St. Louis, United States.
Radiother Oncol. 2022 Feb;167:317-322. doi: 10.1016/j.radonc.2021.11.023. Epub 2021 Dec 4.
Stereotactic body radiotherapy (SBRT) is an attractive treatment option for patients with metastatic and/or unresectable tumors, however its use is limited to smaller tumors. Lattice is a form of spatially fractionated radiotherapy that may allow safe delivery of ablative doses to bulky tumors. We previously described Lattice SBRT, which delivers 20 Gy in 5 fractions with a simultaneous integrated boost to 66.7 Gy in a defined geometric arrangement (Lattice boost). The goal of this study was to prospectively evaluate the acute toxicity and quality of life (QoL) of patients with large tumors (>5 cm) treated with Lattice SBRT.
This was a single-arm phase I trial conducted between October 2019 and August 2020. Patients with tumors > 4.5 cm were eligible. Lattice SBRT was delivered every other day. The primary outcome was the rate of 90-day treatment-associated (probably or definitely attributable) grade 3 + acute toxicity by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 criteria. Other outcomes included changes in patient reported toxicity and QoL inventories, GTV, and peripheral blood cytokines.
Twenty patients (22 tumors) were enrolled. Median GTV was 579.2 cc (range: 54.2-3713.5 cc) in volume and 11.1 cm (range: 5.6-21.4 cm) in greatest axial diameter. Fifty percent of tumors were in the thorax, 45% abdomen/pelvis, and 5% extremity. There was no likely treatment-associated grade 3 + toxicity in the 90-day period (acute and sub-acute). There was one case of grade 4 toxicity possibly associated with Lattice SBRT.
This phase I study met its primary endpoint of physician reported short-term safety. An ongoing phase II clinical trial of Lattice SBRT will evaluate late safety and efficacy of this novel technique.
立体定向体部放疗（SBRT）是一种有吸引力的治疗选择，适用于转移性和/或不可切除的肿瘤患者，但它仅限于较小的肿瘤。格架是一种空间分割放疗形式，可能允许安全地向大体积肿瘤提供消融剂量。我们之前描述了 Lattice SBRT，它以 5 个分次给予 20Gy 的剂量，同时以 66.7Gy 的剂量在一个确定的几何排列（Lattice boost）中进行同步综合增强。本研究的目的是前瞻性评估接受 Lattice SBRT 治疗的大肿瘤（>5cm）患者的急性毒性和生活质量（QoL）。
这是一项在 2019 年 10 月至 2020 年 8 月期间进行的单臂 I 期试验。肿瘤>4.5cm 的患者有资格参加。Lattice SBRT 每隔一天给予一次。主要终点是根据不良事件通用术语标准（CTCAE）第 5.0 版标准，90 天治疗相关（可能或肯定归因）3+级急性毒性的发生率。其他结果包括患者报告的毒性和生活质量量表、GTV 和外周血细胞因子的变化。
共纳入 20 名患者（22 个肿瘤）。GTV 中位数为 579.2cc（范围：54.2-3713.5cc），最大轴向直径为 11.1cm（范围：5.6-21.4cm）。50%的肿瘤位于胸部，45%位于腹部/骨盆，5%位于四肢。在 90 天内没有明显的治疗相关 3+级毒性（急性和亚急性）。有一例 4 级毒性可能与 Lattice SBRT 有关。
这项 I 期研究达到了其主要终点，即医生报告的短期安全性。一项正在进行的 Lattice SBRT Ⅱ期临床试验将评估该新方法的晚期安全性和疗效。
