Phase 2 Trial of Stereotactic Body Radiation Therapy with Dose Escalation Using Simultaneous Integrated Boost for Spinal Metastases

IF 2.2 Q3 ONCOLOGY

Advances in Radiation Oncology Pub Date : 2025-04-25 DOI:10.1016/j.adro.2025.101760

Takamasa Mitsuyoshi MD, PhD , Peter J. K. Tokuda MD , Yumi Kokubo MD , Takahiro Iwai MD , Hiroyuki Inoo MD , Ryo Ashida MD, PhD , Ryosuke Nasada MS , Mikiko Yamashita PhD , Hiroaki Tanabe MS , Shigeki Arizono MD, PhD , Toshiyuki Imagumbai MD , Masaki Kokubo MD, PhD

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引用次数: 0

Abstract

Purpose

Stereotactic body radiation therapy (SBRT) is an effective treatment approach for spinal metastases. However, local recurrence may occur. This prospective phase 2 trial evaluated whether SBRT with dose escalation in the gross tumor volume through simultaneous integrated boost (SIB–SBRT) can improve local control (LC) without increasing adverse events (AEs).

Methods and Materials

Eligible patients aged ≥ 20 years with spinal metastases and a life expectancy of > 1 year received SIB–SBRT in 5 fractions over 1 week. The prescribed dose was 30 Gy to the planning target volume for evaluation and an escalated dose of 40 to 45 Gy to the gross tumor volume through SIB. Neurologic examinations and magnetic resonance imaging were performed at 3-, 6-, and 12-month follow-up and every 6 months thereafter. The primary endpoint was the 1-year LC rate. The secondary endpoints included overall survival and AEs, such as vertebral compression fractures (VCFs).

Results

A total of 25 patients with 28 vertebral segments from September 2020 to March 2023 were enrolled in this study. The median follow-up was 26.2 months, and 24 segments in 21 patients were followed up for >1 year. The 1- and 2-year LC rates were 100.0% and 95.0%, respectively. Local recurrence developed in only 1 patient at 18 months. The 1- and 2-year overall survival rates were 92.0% and 72.8%, respectively. Six patients developed VCFs (3 cases each of grades 1 and 2), with 1- and 2-year cumulative incidence rates of 3.6% and 15.6%, respectively. No radiation myelopathy or other grade ≥ 2 AEs occurred, except for 1 case of grade 2 pain.

Conclusions

Dose-escalated SIB–SBRT for spinal metastases demonstrates excellent LC with acceptable toxicity, supporting the need for a larger comparative trial.

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立体定向体放射治疗剂量递增同时综合增强治疗脊柱转移的二期试验

目的立体定向放射治疗（SBRT）是治疗脊柱转移瘤的有效方法。然而，局部复发可能发生。这项前瞻性2期试验评估了SBRT通过同步综合增强（sibb - SBRT）增加总肿瘤体积的剂量是否可以改善局部控制（LC）而不增加不良事件（ae）。方法与材料：年龄≥20岁的脊柱转移患者，预期寿命为；1年接受为期1周的5次sibb - sbrt治疗。规定剂量为30 Gy，以评估计划目标体积，并通过SIB逐步增加剂量，使总肿瘤体积增加40至45 Gy。随访3个月、6个月、12个月及随访后每6个月行神经系统检查和磁共振成像。主要终点是1年的LC率。次要终点包括总生存期和ae，如椎体压缩性骨折（vcf）。结果2020年9月至2023年3月共纳入25例28节段患者。中位随访26.2个月，21例患者24节段随访1年。1年期和2年期贷款利率分别为100.0%和95.0%。18个月时，仅有1例患者出现局部复发。1年和2年总生存率分别为92.0%和72.8%。6例患者发生vcf（1级和2级各3例），1年和2年累积发病率分别为3.6%和15.6%。除1例2级疼痛外，未发生放射性脊髓病或其他≥2级ae。结论：剂量递增的sibb - sbrt治疗脊柱转移具有良好的LC和可接受的毒性，支持更大规模比较试验的必要性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Advances in Radiation Oncology Medicine-Radiology, Nuclear Medicine and Imaging

CiteScore

4.60

自引率

4.30%

发文量

208

审稿时长

98 days

期刊介绍： The purpose of Advances is to provide information for clinicians who use radiation therapy by publishing: Clinical trial reports and reanalyses. Basic science original reports. Manuscripts examining health services research, comparative and cost effectiveness research, and systematic reviews. Case reports documenting unusual problems and solutions. High quality multi and single institutional series, as well as other novel retrospective hypothesis generating series. Timely critical reviews on important topics in radiation oncology, such as side effects. Articles reporting the natural history of disease and patterns of failure, particularly as they relate to treatment volume delineation. Articles on safety and quality in radiation therapy. Essays on clinical experience. Articles on practice transformation in radiation oncology, in particular: Aspects of health policy that may impact the future practice of radiation oncology. How information technology, such as data analytics and systems innovations, will change radiation oncology practice. Articles on imaging as they relate to radiation therapy treatment.