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单纯骨寡转移乳腺癌立体定向消融体部放疗(SABR):一项前瞻性临床试验。

Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial.

机构信息

Peter MacCallum Cancer Centre, Australia.

Peter MacCallum Cancer Centre, Australia.

出版信息

Breast. 2020 Feb;49:55-62. doi: 10.1016/j.breast.2019.10.016. Epub 2019 Nov 6.

Abstract

BACKGROUND

Stereotactic ablative body radiotherapy (SABR) is an emerging noninvasive approach for the treatment of oligometastases. Limited prospective evidence is available in breast cancer.

OBJECTIVES

To determine the safety and feasibility of single fraction SABR for patients with bone only oligometastatic breast cancer. Secondary endpoints were local and distant progression-free survival (LPFS and DPFS), toxicity and response assessment.

METHODS AND MATERIALS

In this single institution prospective trial we screened patients with computed tomography, bone scan, and sodium fluoride positron emission tomography. Eligible patients had one to three bone only oligometastases. All patients were treated at a dose of 20Gy in 1 fraction to each metastasis. Kaplan-Meier methods were used to determine local and distant progression free survival (LPFS and DPFS). Toxicity was graded using Common Terminology Criteria for Adverse Event version 4.0.

RESULTS

15 eligible patients were recruited to the study. Median follow-up time was 24 months. The treatment was feasible in 12 (80%) of patients with 3 (20%) of patients having treatment delayed by more than 3 days. 10 (67%) of patients experienced grade 1 treatment related toxicity, 4 (27%) experienced grade 2 toxicity and no patients experienced grade 3 or 4 treatment related toxicity. The two-year LPFS was 100%, DPFS was 67%.

CONCLUSION

We observed that SABR is feasible, well tolerated and effective in this cohort with two thirds of patients disease-free at two years. In selected patients with bone-only oligometastatic disease, SABR could be considered a treatment option. Randomised trials are required to assess the impact of SABR on overall survival when compared to the standard of care.

摘要

背景

立体定向消融体放射治疗(SABR)是一种新兴的非侵入性治疗寡转移的方法。在乳腺癌中,只有有限的前瞻性证据。

目的

确定单次 SABR 治疗仅有骨转移的寡转移性乳腺癌患者的安全性和可行性。次要终点是局部和远处无进展生存期(LPFS 和 DPFS)、毒性和反应评估。

方法和材料

在这项单中心前瞻性试验中,我们对 CT、骨扫描和氟代脱氧葡萄糖正电子发射断层扫描进行了筛选。符合条件的患者有一到三个仅骨的寡转移灶。所有患者均接受 20Gy 单次剂量照射,每个转移灶照射 1 次。采用 Kaplan-Meier 法确定局部和远处无进展生存期(LPFS 和 DPFS)。采用通用不良事件术语标准 4.0 分级评估毒性。

结果

15 名符合条件的患者入组研究。中位随访时间为 24 个月。12 名(80%)患者的治疗是可行的,有 3 名(20%)患者的治疗延迟超过 3 天。10 名(67%)患者出现 1 级治疗相关毒性,4 名(27%)患者出现 2 级毒性,无患者出现 3 级或 4 级治疗相关毒性。两年 LPFS 为 100%,DPFS 为 67%。

结论

我们观察到 SABR 在本队列中是可行的、耐受良好且有效的,三分之二的患者在两年内无疾病。在仅有骨转移的寡转移疾病的选定患者中,SABR 可以被视为一种治疗选择。需要进行随机试验来评估与标准治疗相比,SABR 对总生存的影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e51c/7375645/22f261bbeb63/gr1.jpg

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