Department of Radiotherapy and Radiosurgery, IRCCS Humanitas Research Hospital, Via Manzoni 56, 20089 Rozzano - Milan, Italy.
Department of Radiotherapy and Radiosurgery, IRCCS Humanitas Research Hospital, Via Manzoni 56, 20089 Rozzano - Milan, Italy.
Radiother Oncol. 2024 Aug;197:110335. doi: 10.1016/j.radonc.2024.110335. Epub 2024 May 19.
Oligometastases in mediastinal nodes are increasingly prevalent, posing challenges for treatment with stereotactic body radiotherapy (SBRT) due to proximity to organs at risk (OARs). We report the results of a single prospective observational phase II trial on ablative SBRT for medically inoperable thoracic nodes metastases (NCT02970955).
Since 2017, patients with < 3 nodal metastases were evaluated by the tumor board and included if deemed inoperable. SBRT was delivered using risk adaptive approach based on number, site and size of metastatic nodes (50 Gy/5fractions, 60 Gy/8fractions, 70 Gy/10 fractions). Planning target volume (PTV) partial underdosage was allowed. The primary end point was local control (LC) at 12 months. Secondary end points were: acute and late toxicities, overall survival (OS), progression free survival (PFS), and time to next systemic therapy (TTNS).
Between 03/2017-11/2021, 32 patients (41 nodal metastases) were included. NSCLC (13pts), breast (5pts) and colorectal cancer (4pts) were the most represented primary tumour. In 66 % cases, partial PTV undercoverage was necessary. LC at 1 and 2 years was 93.5 % and 82.3 %, respectively. Treatment was well-tolerated with no acute or late toxicity ≥ G3. Median OS was 59.7 months. OS at 1 and 2 years was 96.9 % and 83.8 % respectively. Median PFS was 12.2 months. PFS at 1 and 2 years was 53.1 % and 31.3 %, respectively.
This trial supported the feasibility and safety of ablative SBRT for thoracic nodes metastases thanks to risk adaptive approach allowing to delay of new systemic therapies. Larger studies are needed to confirm these observations.
纵隔淋巴结寡转移的发病率越来越高，由于临近危及器官（OARs），采用立体定向体部放疗（SBRT）治疗具有挑战性。我们报告了一项关于无法手术的胸内淋巴结转移的消融性 SBRT 的单前瞻性观察性 II 期试验结果（NCT02970955）。
自 2017 年以来，肿瘤委员会评估了<3 个淋巴结转移的患者，如果认为无法手术，则将其纳入研究。SBRT 采用基于转移淋巴结数量、部位和大小的风险适应性方法进行（50Gy/5 次分割、60Gy/8 次分割、70Gy/10 次分割）。允许计划靶区（PTV）部分欠量照射。主要终点是 12 个月时的局部控制（LC）。次要终点为：急性和迟发性毒性、总生存（OS）、无进展生存（PFS）和下一次全身治疗时间（TTNS）。
在 2017 年 3 月至 2021 年 11 月期间，共纳入 32 名患者（41 个淋巴结转移）。非小细胞肺癌（13 例）、乳腺癌（5 例）和结直肠癌（4 例）是最常见的原发性肿瘤。在 66%的病例中，需要部分 PTV 欠量照射。1 年和 2 年时的 LC 分别为 93.5%和 82.3%。治疗耐受性良好，无急性或迟发性毒性≥3 级。中位 OS 为 59.7 个月。1 年和 2 年的 OS 分别为 96.9%和 83.8%。中位 PFS 为 12.2 个月。1 年和 2 年的 PFS 分别为 53.1%和 31.3%。
这项试验支持了基于风险适应性方法的消融性 SBRT 治疗胸内淋巴结转移的可行性和安全性，该方法可延迟新的全身治疗。需要更大规模的研究来证实这些观察结果。
