STRILL:评估立体定向体外放射治疗 (SBRT) 剂量升级用于无法手术的周围肺部病变再照射的 I 期试验

Diseases Pub Date : 2024-07-12 DOI:10.3390/diseases12070153
D. Franceschini, M. Loi, A. Marzo, L. Dominici, R. Spoto, A. Bertolini, L. Lo Faro, Francesco La Fauci, B. Marini, L. di Cristina, M. Scorsetti
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引用次数: 0

摘要

关于SBRT再照射治疗孤立复发的作用,目前鲜有数据。我们设计了一项前瞻性 I 期研究,以评估 SBRT 用于胸腔再放射治疗外周肺部病变的最大耐受剂量 (MTD)。放射治疗采用剂量递增设计,从 30 Gy(5 次分次)到 50 Gy(5 次分次)。主要终点是确定SBRT用于胸部再照射的最大耐受剂量(MTD)。剂量限制性毒性为肺炎≥G3。共有 15 名患者入组。我们的队列中没有出现肺炎≥G3的病例。只有一名患者在治疗期间出现了肺炎 G1。三名患者出现了急性毒性反应,包括呼吸困难 G1、心力衰竭 G3 和胸壁疼痛。一名患者出现了 G3 级晚期毒性,并伴有急性冠状动脉综合征。中位随访 21 个月(3.6-29.1 个月)后,6 名患者(40%)出现局部复发。5名患者(33.3%)出现远处复发。在最后一次随访中,六名患者死亡,除两人外,其余均死于疾病进展。SBRT剂量升级胸腔再照射对于首次胸腔RT后无法手术的肺部病变患者来说是一种有效且耐受性良好的选择,其急性和晚期毒性反应均可接受。
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STRILL: Phase I Trial Evaluating Stereotactic Body Radiotherapy (SBRT) Dose Escalation for Re-Irradiation of Inoperable Peripheral Lung Lesions
Few data are available on the role of SBRT re-irradiation for isolated recurrences. We designed a prospective phase I study to evaluate the maximum tolerated dose (MTD) of SBRT for thoracic re-irradiation, for peripheral lung lesions. RT was delivered with a dose escalation design from 30 Gy in five fractions up to 50 Gy in five fractions. The primary end point was the definition of the maximum tolerated dose (MTD) of SBRT for thoracic re-irradiation. The dose-limiting toxicity was pneumonia ≥G3. Fifteen patients were enrolled. No cases of pneumonia ≥G3 occurred in any of our cohorts. Only one patient developed pneumonia G1 during treatment. Three patients developed acute toxicities that included dyspnea G1, cardiac failure G3, and chest wall pain. One patient developed G3 late toxicity with acute coronary syndrome. After a median follow-up of 21 months (range 3.6–29.1 months), six patients (40%) had a local relapse. Distant relapse occurred in five patients (33.3%). At the last follow-up, six patients died, all but two due to progressive disease. SBRT dose escalation for thoracic re-irradiation is an effective and well-tolerated option for patients with inoperable lung lesions after a first thoracic RT with acceptable acute and late toxicities.
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