Abstract
Effect and safety of combining bevacizumab and fractionated stereotactic radiotherapy for brain metastases in patients with non-small cell lung cancer: A phase II trial.
Author
person
Rui Zhou
Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China, Guangzhou, Guangdong, China
info_outline
Rui Zhou, ShiYang Zheng, LanQing Huo, QiaoTing Luo, DaQuan Wang, JinYu Guo, BiaoShui Liu, Jun Zhang, Bin Wang, Bo Qiu, Hui Liu
Full text
Authors
person
Rui Zhou
Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China, Guangzhou, Guangdong, China
info_outline
Rui Zhou, ShiYang Zheng, LanQing Huo, QiaoTing Luo, DaQuan Wang, JinYu Guo, BiaoShui Liu, Jun Zhang, Bin Wang, Bo Qiu, Hui Liu
Organizations
Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China, Guangzhou, Guangdong, China, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China, Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China, Guangzhou, China
Abstract Disclosures
Research Funding
No funding received
None.
Background:
W
e aimed to assess the
efficacy and
safety
of
c
ombining
b
evacizumab and fractionated
stereotactic radiotherapy
(
FSRT
)
for brain metastases
(BMs)
in
non-small cell lung cancer
(
NSCLC
)
patients with stable extracranial disease status in this study.
Methods:
NSCLC patients with
BMs
were recruited between J
anuary
20
20
and J
anuary
202
2
.
P
atients
were assigned to receive FSRT of 40Gy in 10 fractions (BED 56eGy) or 30Gy in 5 fractions (BED 48eGy). Meanwhile, bevacizumab was administered before FSRT (d1) and after FSRT (d21) with a dosage of 7.5mg/Kg.
The primary endpoint of the study is intra-cranial progression-free survival (IPFS)
.
The secondary endpoints contained overall survival (OS),
progression-free survival (PFS)
,
quality of life (QOL) score
and toxicities. All time-to-event endpoints (IPFS, OS and PFS) were measured from the end of radiotherapy.
Results:
From
J
anuary
2020
and J
anuary
202
2, 108 patients were
recruited
with a
median follow-up duration
was
15.2
months
. The 1-year IPFS and OS rate were 82.9% (
95% confidence interval (CI),
79.6%-86.2%
) and 80.4% (
95% CI,
76.8%-84.0%
),
respectively
. The median PFS was 15.0 months
(
95% CI,
9.50-20.50 months
). The median IPFS and OS had not been reached at the time of the last follow-up. The treatment-related toxicities were mild with low incidence. Reversible mild hypertension and
cerebral radio-necrosis
were observed in 2 and 1 patients, respectively. No signs of ex
tra-lesional haemorrhage
and progression of peri-lesional oedema was found during the assessment period of treatment response.
More importantly, significant improvent of QOL was observed in symptomatic patients.
Conclusions:
The combination of FSRT with bevacizumab in patients with NSCLC was well tolerated and achieved promising intracranial disease control. Patients maintained satisfactory QOL after receiving the combined regimen with low incidence of cerebral radio-necrosis.
Clinical trial information: NCT04345146.
Clinical status
Clinical
1 clinical trial
4 organizations
1 drug
1 target
Clinical trial
A Prospective, Phase II Study of Bevacizumab Combined With Fractionated Stereotactic Radiotherapy in Patients With 1 to 10 Brain Metastases From Non-small Cell Lung CancerStatus: Completed, Estimated PCD: 2023-03-31
Drug
bevacizumabTarget
VEGF and c-MET pathways