Efficacy and safety of online adaptive magnetic resonance-guided fractionated stereotactic radiotherapy for brain metastases in non-small cell lung cancer (GASTO-1075): a single-arm, phase 2 trialResearch in context
Summary: Background: Brain metastases (BMs) in non-small cell lung cancer (NSCLC) are associated with poor prognosis and quality of life (QoL). This study aimed to evaluate the efficacy and safety of online adaptive MR-guided fractionated stereotactic radiotherapy (FSRT) using a 1.5 T MR-Linac in t...
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Elsevier
2025-04-01
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| author | Shiyang Zheng Shouliang Ding Biaoshui Liu Yixin Xiong Rui Zhou Pengxin Zhang Fangjie Liu Yimei Liu Meining Chen Yu Situ Mengru Wang Xiaoyan Huang Shaohan Yin Wenfeng Fang Yonggao Mou Bo Qiu Daquan Wang Hui Liu |
| author_facet | Shiyang Zheng Shouliang Ding Biaoshui Liu Yixin Xiong Rui Zhou Pengxin Zhang Fangjie Liu Yimei Liu Meining Chen Yu Situ Mengru Wang Xiaoyan Huang Shaohan Yin Wenfeng Fang Yonggao Mou Bo Qiu Daquan Wang Hui Liu |
| author_sort | Shiyang Zheng |
| collection | DOAJ |
| description | Summary: Background: Brain metastases (BMs) in non-small cell lung cancer (NSCLC) are associated with poor prognosis and quality of life (QoL). This study aimed to evaluate the efficacy and safety of online adaptive MR-guided fractionated stereotactic radiotherapy (FSRT) using a 1.5 T MR-Linac in this subgroup of patients. Methods: This single-arm phase 2 trial was conducted at Sun Yat-sen University Cancer Centre. Patients aged 18–75 years with NSCLC, 1–10 BMs, and an ECOG status of 0–1 were included. Key exclusion criteria included inability to undergo contrast-enhanced MRI and contraindications to bevacizumab. Patients received 30 Gy adaptive FSRT in 5 daily fractions under real-time MR guidance, with bevacizumab before (day 1) and after (day 21) FSRT. The primary endpoint was 1-year intracranial progression-free survival (IPFS); secondary endpoints included objective response rate (ORR), 1-year progression-free survival (PFS), 1-year overall survival (OS), treatment-related toxicities, and QoL. All enrolled patients were included in primary and safety analyses. This trial is registered with Clinicaltrials.gov, NCT04946019. Findings: Between June 10th, 2021 and June 29th, 2023, 70 patients were assessed for eligibility and 55 patients were enrolled (median follow-up: 22.3 months). The median age was 58 years (IQR: 51–65), with 33% (18/55) female patients, and 82% (45/55) presenting with adenocarcinoma. The 1-year IPFS rate was 78.7% (95% CI, 68.2%–90.7%), with a median IPFS of 21.9 months (95% CI, 13.8–30.1 months). The 1-year PFS rate was 63.5% (95% CI: 51.8%–78.2%), and OS was 82.4% (95% CI: 72.6%–93.6%). The ORR reached 78% (95% CI: 65.0%–88.2%). Treatment-related toxicity was minimal, with only one case (2%) of grade 1 radiation necrosis. QoL improved steadily, with the Global Health Status score increasing from 65.67 ± 16.97 to 79.33 ± 8.79 at 6 months post FSRT (p < 0.0001). Interpretation: Online adaptive FSRT using a 1.5 T MR-Linac has demonstrated effectiveness and good tolerability for BMs in patients with NSCLC. However, the relatively small sample size and short follow-up may affect result generalizability. Further randomised studies are warranted to confirm these findings and establish optimal treatment protocols. Funding: The National Natural Science Foundation of China (Grant Number 82073328). |
| format | Article |
| id | doaj-art-13400aaf9fef4899893286ea3ad67cf7 |
| institution | DOAJ |
| issn | 2589-5370 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Elsevier |
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| series | EClinicalMedicine |
| spelling | doaj-art-13400aaf9fef4899893286ea3ad67cf72025-08-20T03:05:17ZengElsevierEClinicalMedicine2589-53702025-04-018210318910.1016/j.eclinm.2025.103189Efficacy and safety of online adaptive magnetic resonance-guided fractionated stereotactic radiotherapy for brain metastases in non-small cell lung cancer (GASTO-1075): a single-arm, phase 2 trialResearch in contextShiyang Zheng0Shouliang Ding1Biaoshui Liu2Yixin Xiong3Rui Zhou4Pengxin Zhang5Fangjie Liu6Yimei Liu7Meining Chen8Yu Situ9Mengru Wang10Xiaoyan Huang11Shaohan Yin12Wenfeng Fang13Yonggao Mou14Bo Qiu15Daquan Wang16Hui Liu17State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Lung Cancer Institute of Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Association Study of Thoracic Oncology, Guangzhou, Guangdong, ChinaState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, ChinaState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, ChinaGuangdong University of Foreign Studies, School of Economics and Trade, Guangzhou, Guangdong, ChinaState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Lung Cancer Institute of Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Association Study of Thoracic Oncology, Guangzhou, Guangdong, ChinaState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Lung Cancer Institute of Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Association Study of Thoracic Oncology, Guangzhou, Guangdong, ChinaState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Lung Cancer Institute of Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Association Study of Thoracic Oncology, Guangzhou, Guangdong, ChinaState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, ChinaState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, ChinaState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Lung Cancer Institute of Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Association Study of Thoracic Oncology, Guangzhou, Guangdong, ChinaState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Lung Cancer Institute of Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Association Study of Thoracic Oncology, Guangzhou, Guangdong, ChinaState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, ChinaState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Department of Radiology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, ChinaState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, ChinaState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Department of Neurosurgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong Province, ChinaState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Lung Cancer Institute of Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Association Study of Thoracic Oncology, Guangzhou, Guangdong, China; Corresponding author. No. 651 Dongfeng Road East, Guangzhou, 510060, China.State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Lung Cancer Institute of Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Association Study of Thoracic Oncology, Guangzhou, Guangdong, China; Corresponding author. No. 651 Dongfeng Road East, Guangzhou, 510060, China.State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Lung Cancer Institute of Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Association Study of Thoracic Oncology, Guangzhou, Guangdong, China; Corresponding author. No. 651 Dongfeng Road East, Guangzhou, 510060, China.Summary: Background: Brain metastases (BMs) in non-small cell lung cancer (NSCLC) are associated with poor prognosis and quality of life (QoL). This study aimed to evaluate the efficacy and safety of online adaptive MR-guided fractionated stereotactic radiotherapy (FSRT) using a 1.5 T MR-Linac in this subgroup of patients. Methods: This single-arm phase 2 trial was conducted at Sun Yat-sen University Cancer Centre. Patients aged 18–75 years with NSCLC, 1–10 BMs, and an ECOG status of 0–1 were included. Key exclusion criteria included inability to undergo contrast-enhanced MRI and contraindications to bevacizumab. Patients received 30 Gy adaptive FSRT in 5 daily fractions under real-time MR guidance, with bevacizumab before (day 1) and after (day 21) FSRT. The primary endpoint was 1-year intracranial progression-free survival (IPFS); secondary endpoints included objective response rate (ORR), 1-year progression-free survival (PFS), 1-year overall survival (OS), treatment-related toxicities, and QoL. All enrolled patients were included in primary and safety analyses. This trial is registered with Clinicaltrials.gov, NCT04946019. Findings: Between June 10th, 2021 and June 29th, 2023, 70 patients were assessed for eligibility and 55 patients were enrolled (median follow-up: 22.3 months). The median age was 58 years (IQR: 51–65), with 33% (18/55) female patients, and 82% (45/55) presenting with adenocarcinoma. The 1-year IPFS rate was 78.7% (95% CI, 68.2%–90.7%), with a median IPFS of 21.9 months (95% CI, 13.8–30.1 months). The 1-year PFS rate was 63.5% (95% CI: 51.8%–78.2%), and OS was 82.4% (95% CI: 72.6%–93.6%). The ORR reached 78% (95% CI: 65.0%–88.2%). Treatment-related toxicity was minimal, with only one case (2%) of grade 1 radiation necrosis. QoL improved steadily, with the Global Health Status score increasing from 65.67 ± 16.97 to 79.33 ± 8.79 at 6 months post FSRT (p < 0.0001). Interpretation: Online adaptive FSRT using a 1.5 T MR-Linac has demonstrated effectiveness and good tolerability for BMs in patients with NSCLC. However, the relatively small sample size and short follow-up may affect result generalizability. Further randomised studies are warranted to confirm these findings and establish optimal treatment protocols. Funding: The National Natural Science Foundation of China (Grant Number 82073328).http://www.sciencedirect.com/science/article/pii/S258953702500121XBrain metastasesNSCLCFractionated stereotactic radiotherapyMR-LinacAdaptive radiotherapy |
| spellingShingle | Shiyang Zheng Shouliang Ding Biaoshui Liu Yixin Xiong Rui Zhou Pengxin Zhang Fangjie Liu Yimei Liu Meining Chen Yu Situ Mengru Wang Xiaoyan Huang Shaohan Yin Wenfeng Fang Yonggao Mou Bo Qiu Daquan Wang Hui Liu Efficacy and safety of online adaptive magnetic resonance-guided fractionated stereotactic radiotherapy for brain metastases in non-small cell lung cancer (GASTO-1075): a single-arm, phase 2 trialResearch in context EClinicalMedicine Brain metastases NSCLC Fractionated stereotactic radiotherapy MR-Linac Adaptive radiotherapy |
| title | Efficacy and safety of online adaptive magnetic resonance-guided fractionated stereotactic radiotherapy for brain metastases in non-small cell lung cancer (GASTO-1075): a single-arm, phase 2 trialResearch in context |
| title_full | Efficacy and safety of online adaptive magnetic resonance-guided fractionated stereotactic radiotherapy for brain metastases in non-small cell lung cancer (GASTO-1075): a single-arm, phase 2 trialResearch in context |
| title_fullStr | Efficacy and safety of online adaptive magnetic resonance-guided fractionated stereotactic radiotherapy for brain metastases in non-small cell lung cancer (GASTO-1075): a single-arm, phase 2 trialResearch in context |
| title_full_unstemmed | Efficacy and safety of online adaptive magnetic resonance-guided fractionated stereotactic radiotherapy for brain metastases in non-small cell lung cancer (GASTO-1075): a single-arm, phase 2 trialResearch in context |
| title_short | Efficacy and safety of online adaptive magnetic resonance-guided fractionated stereotactic radiotherapy for brain metastases in non-small cell lung cancer (GASTO-1075): a single-arm, phase 2 trialResearch in context |
| title_sort | efficacy and safety of online adaptive magnetic resonance guided fractionated stereotactic radiotherapy for brain metastases in non small cell lung cancer gasto 1075 a single arm phase 2 trialresearch in context |
| topic | Brain metastases NSCLC Fractionated stereotactic radiotherapy MR-Linac Adaptive radiotherapy |
| url | http://www.sciencedirect.com/science/article/pii/S258953702500121X |
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