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立体定向体部放疗治疗寡转移肉瘤肺转移瘤患者的Ⅱ期研究

Stereotactic Body Radiation Therapy for Lung Metastases From Sarcoma in Oligometastatic Patients: A Phase 2 Study.

机构信息

Radiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.

Radiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.

出版信息

Int J Radiat Oncol Biol Phys. 2022 Nov 15;114(4):762-770. doi: 10.1016/j.ijrobp.2022.08.028. Epub 2022 Aug 18.

DOI:10.1016/j.ijrobp.2022.08.028
PMID:35987453
Abstract

PURPOSE

The lung is the most frequent site of metastasis in patients with sarcoma. Pulmonary metastasectomy is the most common treatment performed. Stereotactic body radiation therapy (SBRT) has proven to be a potential alternative to resection. This prospective phase 2 study aimed to assess the role of SBRT for patients with lung metastases.

METHODS AND MATERIALS

Adult patients with up to 4 lung metastases (LMs) ≤5 cm in diameter and unsuitable for surgery were included. Dose prescription was based on site and size: 30 Gy/1 fraction for peripheral lesions ≤10 mm, 60 Gy/3 fractions for peripheral lesions 11 to 20 mm, 48 Gy/4 fractions for peripheral lesions >20 mm, and 60 Gy/8 fractions for central lesions. The primary endpoint was the proportion of treated lesions free from progression at 12 months. Secondary endpoints were disease-free survival (DFS), overall survival (OS), and toxicity.

RESULTS

Between March 2015 and December 2020, 44 patients with a total of 71 LMs were enrolled. Twelve-month local control was 98.5% ± 1.4%, reaching the primary aim; the median DFS time was 12 months (95% CI, 8-16 months), and the 1-, 2-, 3-, 4-, and 5-year PFS rates were 50% ± 7.5%, 19.5% ± 6.6%, 11.7% ± 5.8%, 11.7% ± 5.8%, and 11.7% ± 5.8%, respectively. The median OS time was 49 months (95% CI, 24-49 months), and the 1-, 2-, 3-, 4-, and 5-year OS rates were 88.6% ± 4.7%, 66.7 ± 7.6%, 56.8% ± 8.4%, 53.0% ± 8.6%, and 48.2% ± 9.1%, respectively. Prognostic factors recorded as significantly affecting survival were age, grade of primary sarcoma, interval time from diagnosis to occurrence of LMs, and number of LMs. No severe pulmonary toxicity (grade 3-4) occurred.

CONCLUSIONS

The study found a local control of LMs in almost all patients treated, with negligible toxicity. Survival was also highly satisfactory. Well-designed randomized trials comparing surgery with SBRT for patients with metastatic lung sarcoma are needed to confirm these preliminary data.

摘要

目的

肺部是肉瘤患者转移的最常见部位。肺转移瘤切除术是最常见的治疗方法。立体定向体部放射治疗(SBRT)已被证明是一种有潜力的替代手术的方法。本前瞻性 2 期研究旨在评估 SBRT 治疗肺转移瘤患者的作用。

方法和材料

纳入了最多有 4 个直径≤5cm 的肺部转移灶(LM)且不适合手术的成年患者。剂量处方基于部位和大小:对于≤10mm 的外周病变,给予 30Gy/1 次分割;对于 11-20mm 的外周病变,给予 60Gy/3 次分割;对于>20mm 的外周病变,给予 48Gy/4 次分割;对于中央病变,给予 60Gy/8 次分割。主要终点是 12 个月时无进展治疗病灶的比例。次要终点是无病生存率(DFS)、总生存率(OS)和毒性。

结果

2015 年 3 月至 2020 年 12 月,共纳入了 44 例患者,共 71 个 LM。12 个月时的局部控制率为 98.5%±1.4%,达到了主要目标;中位 DFS 时间为 12 个月(95%CI,8-16 个月),1、2、3、4 和 5 年的 PFS 率分别为 50%±7.5%、19.5%±6.6%、11.7%±5.8%、11.7%±5.8%和 11.7%±5.8%。中位 OS 时间为 49 个月(95%CI,24-49 个月),1、2、3、4 和 5 年的 OS 率分别为 88.6%±4.7%、66.7%±7.6%、56.8%±8.4%、53.0%±8.6%和 48.2%±9.1%。记录的影响生存的预后因素有年龄、原发肉瘤的分级、从诊断到发生 LM 的时间间隔和 LM 的数量。未发生严重的肺部毒性(3-4 级)。

结论

研究发现,接受治疗的患者几乎所有 LM 均达到局部控制,毒性可忽略不计。生存情况也非常令人满意。需要设计良好的随机试验来比较手术与 SBRT 治疗转移性肺肉瘤患者,以确认这些初步数据。

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