Abstract：
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.
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.
摘要：
背景：纵隔淋巴结中的寡节转移越来越普遍，由于靠近危险器官（OAR），对立体定向放射治疗（SBRT）的治疗提出了挑战。我们报告了一项关于消融性SBRT治疗无法手术的胸淋巴结转移的单一前瞻性观察性II期试验的结果（NCT02970955）。
方法：自2017年以来，肿瘤委员会对<3个淋巴结转移的患者进行了评估，如果认为无法手术，则将其包括在内。SBRT采用基于数字的风险自适应方法交付，转移淋巴结的部位和大小(50Gy/5个部分，60Gy/8分数，70Gy/10分数)。计划目标体积（PTV）允许部分剂量不足。主要终点是12个月时的局部控制（LC）。次要终点是：急性和晚期毒性，总生存期（OS），无进展生存期（PFS），以及下一次全身治疗（TTNS）的时间。
结果：在2017-11/2021之间，包括32例患者（41个淋巴结转移）。非小细胞肺癌（13分），乳腺癌(5例)和结直肠癌(4例)是最常见的原发肿瘤.在66%的案例中，部分PTV覆盖是必要的。1年和2年的LC分别为93.5%和82.3%，分别。治疗耐受性良好，无急性或晚期毒性≥G3。OS中位数为59.7个月。1年和2年的OS分别为96.9%和83.8%。PFS中位数为12.2个月。1年和2年的PFS分别为53.1%和31.3%，分别。
结论：该试验支持消融性SBRT治疗胸淋巴结转移的可行性和安全性，这归功于风险适应性方法允许延迟新的全身治疗。需要更大规模的研究来证实这些观察结果。
方法：自2017年以来，肿瘤委员会对<3个淋巴结转移的患者进行了评估，如果认为无法手术，则将其包括在内。SBRT采用基于数字的风险自适应方法交付，转移淋巴结的部位和大小(50Gy/5个部分，60Gy/8分数，70Gy/10分数)。计划目标体积（PTV）允许部分剂量不足。主要终点是12个月时的局部控制（LC）。次要终点是：急性和晚期毒性，总生存期（OS），无进展生存期（PFS），以及下一次全身治疗（TTNS）的时间。
结果：在2017-11/2021之间，包括32例患者（41个淋巴结转移）。非小细胞肺癌（13分），乳腺癌(5例)和结直肠癌(4例)是最常见的原发肿瘤.在66%的案例中，部分PTV覆盖是必要的。1年和2年的LC分别为93.5%和82.3%，分别。治疗耐受性良好，无急性或晚期毒性≥G3。OS中位数为59.7个月。1年和2年的OS分别为96.9%和83.8%。PFS中位数为12.2个月。1年和2年的PFS分别为53.1%和31.3%，分别。
结论：该试验支持消融性SBRT治疗胸淋巴结转移的可行性和安全性，这归功于风险适应性方法允许延迟新的全身治疗。需要更大规模的研究来证实这些观察结果。
