%0 Journal Article
%A Zhou, Xiaojuan
%A Zhou, Laiyan
%A Yao, Zhuoran
%A Huang, Meijuan
%A Gong, Youling
%A Zou, Bingwen
%A Zhu, Jiang
%A Liu, Yongmei
%A Peng, Feng
%A Zhang, Yan
%A Yu, Min
%A Li, Yanying
%A Na, Feifei
%A Wu, Yijun
%A Kang, Kai
%A Xiu, Weigang
%A Zhang, Xuanwei
%A Zhou, Lin
%A Xu, Yong
%A Wang, Jin
%A Wang, Yan
%A Yang, Xue
%A Wu, Yuanjun
%A Li, Rui
%A Zhang, Yu
%A Yang, Zhenzhou
%A Zhou, Zhipeng
%A Bai, Jing
%A Yi, Xin
%A Tong, Ruizhan
%A Yin, Limei
%A Chen, Chong
%A Niedermann, Gabriele
%A Lu, You
%A Xue, Jianxin
%T Safety and Tolerability of Low-Dose Radiation and Stereotactic Body Radiotherapy + Sintilimab for Treatment-Naive Stage IV PD-L1+ Non-Small-Cell Lung Cancer Patients.
%J Clinical cancer research
%V 29
%N 20
%@ 1078-0432
%C Philadelphia, Pa. [u.a.]
%I AACR
%M DKFZ-2023-01663
%P 4098-4108
%D 2023
%Z 2023 Oct 13;29(20):4098-4108
%X Low-dose radiation therapy (LDRT) may enhance the synergistic anti-tumor effect of combined immunotherapy and stereotactic body radiation therapy (SBRT). The safety and efficacy of this novel triple-combination therapy were evaluated for the first time as first-line treatment for patients with metastatic non-small-cell lung cancer (NSCLC).This prospective phase 1 study enrolled 29 patients and included a dose-escalation and dose-expansion phase. Patients received SBRT (30 Gy/3f) to small lesions and LDRT (2 Gy/1f, 4 Gy/2f, or 10 Gy/5f) to a large lesion concurrently, followed by sintilimab (a PD-1 inhibitor). The primary endpoint was safety and tolerability; secondary endpoints included objective response rate (ORR), progression-free survival (PFS), and overall survival (OS).No dose-limiting toxicities were observed during the dose-escalation phase; 4 Gy/2f was the recommended LDRT dose. Median follow-up was 15.6 months. Treatment-related adverse events (TRAEs) occurred in 96.6
%F PUB:(DE-HGF)16
%9 Journal Article
%$ pmid:37581611
%R 10.1158/1078-0432.CCR-23-0315
%U https://inrepo02.dkfz.de/record/278582