Department of Oncology, Copenhagen University Hospital - Herlev and Gentofte, Borgmester Ib Juuls Vej 1, 2730 Herlev, Denmark.
Department of Oncology, Odense University Hospital, J.B. Winsløws Vej 4, 5000 Odense C, Denmark; OPEN, Open Patient data Explorative Network at Odense University Hospital, J.B. Winsløws Vej 9a, 5000 Odense C, Denmark.
Radiother Oncol. 2024 Mar;192:110090. doi: 10.1016/j.radonc.2024.110090. Epub 2024 Jan 13.
The SOFT trial is a prospective, multicenter, phase 2 trial investigating magnetic resonance (MR)-guided stereotactic ablative radiotherapy (SABR) for abdominal, soft tissue metastases in patients with oligometastatic disease (OMD) (clinicaltrials.gov ID NCT04407897). We present the primary endpoint analysis of 1-year treatment-related toxicity (TRAE).
Patients with up to five oligometastases from non-hematological cancers were eligible for inclusion. A risk-adapted strategy prioritized fixed organs at risk (OAR) constraints over target coverage. Fractionation schemes were 45-67.5 Gy in 3-8 fractions. The primary endpoint was grade ≥ 4 TRAE within 12 months post-SABR. The association between the risk of gastrointestinal (GI) toxicity and clinical and dosimetric parameters was tested using a normal tissue complication probability model.
We included 121 patients with 147 oligometastatic targets, mainly located in the liver (41 %), lymph nodes (35 %), or adrenal glands (14 %). Nearly half of all targets (48 %, n = 71) were within 10 mm of a radiosensitive OAR. No grade 4 or 5 TRAEs, 3.5 % grade 3 TRAEs, and 43.7 % grade 2 TRAEs were reported within the first year of follow-up. We found a significant association between grade ≥ 2 GI toxicity and the parameters GI OAR D D and D.
In this phase II study of MR-guided SABR of oligometastases in the infra-diaphragmatic region, we found a low incidence of toxicity despite half of the lesions being within 10 mm of a radiosensitive OAR. GI OAR D D and D were associated with grade ≥ 2 GI toxicity.
SOFT 试验是一项前瞻性、多中心、2 期试验，旨在研究磁共振（MR）引导下立体定向消融放疗（SABR）治疗寡转移疾病（OMD）患者腹部、软组织转移灶（clinicaltrials.gov ID NCT04407897）。我们报告了 1 年治疗相关毒性（TRAE）的主要终点分析结果。
最多有 5 个来自非血液系统癌症的寡转移灶的患者有资格入组。风险适应性策略优先考虑固定的危及器官（OAR）限制，而不是目标覆盖范围。分割方案为 45-67.5Gy，分 3-8 次。主要终点是 SABR 后 12 个月内发生的≥4 级 TRAE。使用正常组织并发症概率模型测试胃肠道（GI）毒性与临床和剂量学参数之间的相关性。
我们纳入了 121 例患者的 147 个寡转移灶，主要位于肝脏（41%）、淋巴结（35%）或肾上腺（14%）。近一半的所有靶区（48%，n=71）位于 10mm 以内的放射敏感 OAR。在随访的第一年，没有报告 4 级或 5 级 TRAE，3.5%的患者出现 3 级 TRAE，43.7%的患者出现 2 级 TRAE。我们发现，≥2 级 GI 毒性与 GI OAR D D 和 D 之间存在显著相关性。
在这项 MR 引导的下腹部寡转移灶 SABR 的 2 期研究中，尽管一半的病变位于 10mm 以内的放射敏感 OAR 范围内，我们发现毒性发生率较低。GI OAR D D 和 D 与≥2 级 GI 毒性相关。
