Whole Brain Radiotherapy Versus Stereotactic Radiosurgery in Breast Cancer Patients With Brain Metastases-A Phase 3 Open Label Randomized Study.

IF 1.6 4区医学 Q4 ONCOLOGY

Asia-Pacific journal of clinical oncology Pub Date : 2025-09-22 DOI:10.1111/ajco.70029

Budhi Singh Yadav, Porva Vias, Ngangom Robert, Venkata Krishna Vamsi Gade, Aashima Kajla

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引用次数: 0

Abstract

Background: Patients with brain metastases can be treated with whole-brain radiotherapy (WBRT) or stereotactic radiosurgery (SRS). There are no randomized study comparing WBRT with SRS in patients with brain metastases from breast cancer. This study aimed to compare WBRT with SRS in patients with breast cancer with brain metastases.

Material and methods: Breast cancer patients with 1-5 brain metastases, ≤ 3.5 cm and KPS ≥ 60 were randomized to WBRT or SRS. WBRT dose was 30 Gy/10 fractions /2 weeks. SRS dose varied from 18 to 24 Gy per fraction to 27-36 Gy in 3-6 fractions. Primary endpoint was overall survival (OS) and the secondary end points were progression free survival (PFS), performance and neurologic status, and cognitive impairment. The trial was approved by the institute ethics committee and registered in clinicaltrials.gov NCT05144867.

Results: Between July 2021 and January 2023, 103 patients were randomized; 51 in the WBRT arm and 52 in the SRS arm. Mean tumor diameter was 3.40 ± 1.22 and 2.81 ± 1.24 cm in WBRT and SRS, respectively. The median follow-up duration was 17.5 months (IQR- 7-21.9 months). Local recurrences were observed in five (9%) and nine (17%) patients in the WBRT and SRS (p = 0.32) group, respectively. Distant intracranial relapse occurred in 11 (21%) and 20 (39%) patients treated with WBRT and SRS (p = 0.36), respectively. Median OS was 17.4 months (95% CI: 6.63-17.8 months) in the WBRT arm and 14.6 months (95% CI: 14-15.2 months) in the SRS arm (p = 0.817). Median PFS was 13.9 and 11.0 months, respectively, for WBRT and SRS (p = 0.73). The 1-year OS and PFS were 55% and 47% (p = 0.51) and 41% and 43% (p = 0.75) with WBRT and SRS, respectively. At 3 months, patients treated with WBRT showed significantly better improvement in KPS (p = 0.004). In both the arms the MMSE improved at 3 months from the baseline, but it was greater with SRS.

Conclusion: There was no significant difference in the outcomes between the SRS and WBRT in breast cancer patients with brain metastasis. WBRT led to a significant improvement in the KPS. Cognitive decline was lower in the SRS arm.

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全脑放疗与立体定向放疗在乳腺癌脑转移患者中的应用——一项3期开放标签随机研究

背景：脑转移患者可采用全脑放疗（WBRT）或立体定向放射手术（SRS）治疗。目前还没有比较WBRT和SRS治疗乳腺癌脑转移患者的随机研究。本研究旨在比较WBRT与SRS在乳腺癌脑转移患者中的疗效。材料与方法：将1-5例脑转移、≤3.5 cm、KPS≥60的乳腺癌患者随机分为WBRT组和SRS组。WBRT剂量为30 Gy/10份/2周。SRS剂量从每组分18 - 24 Gy到每3-6组分27-36 Gy不等。主要终点是总生存期（OS），次要终点是无进展生存期（PFS）、表现和神经状态以及认知障碍。该试验已获得研究所伦理委员会的批准，并在clinicaltrials.gov注册NCT05144867。结果：在2021年7月至2023年1月期间，103例患者被随机化；WBRT组51例，SRS组52例。WBRT组和SRS组平均肿瘤直径分别为3.40±1.22 cm和2.81±1.24 cm。中位随访时间为17.5个月（IQR- 7-21.9个月）。WBRT组局部复发5例（9%），SRS组局部复发9例（17%）（p = 0.32）。WBRT和SRS治疗的远处颅内复发分别为11例（21%）和20例（39%）（p = 0.36）。WBRT组的中位OS为17.4个月（95% CI: 6.63-17.8个月），SRS组的中位OS为14.6个月（95% CI: 14-15.2个月）（p = 0.817）。WBRT和SRS的中位PFS分别为13.9个月和11.0个月（p = 0.73）。WBRT组和SRS组的1年OS和PFS分别为55%和47% （p = 0.51）和41%和43% （p = 0.75）。3个月时，接受WBRT治疗的患者KPS明显改善（p = 0.004）。两组的MMSE在3个月时均较基线有所改善，但SRS组的MMSE更大。结论：SRS与WBRT治疗乳腺癌脑转移患者的预后无显著差异。WBRT显著改善了KPS。SRS组的认知能力下降较低。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Asia-Pacific journal of clinical oncology 医学-肿瘤学

CiteScore

3.40

自引率

0.00%

发文量

175

审稿时长

6-12 weeks

期刊介绍： Asia–Pacific Journal of Clinical Oncology is a multidisciplinary journal of oncology that aims to be a forum for facilitating collaboration and exchanging information on what is happening in different countries of the Asia–Pacific region in relation to cancer treatment and care. The Journal is ideally positioned to receive publications that deal with diversity in cancer behavior, management and outcome related to ethnic, cultural, economic and other differences between populations. In addition to original articles, the Journal publishes reviews, editorials, letters to the Editor and short communications. Case reports are generally not considered for publication, only exceptional papers in which Editors find extraordinary oncological value may be considered for review. The Journal encourages clinical studies, particularly prospectively designed clinical trials.