TY - JOUR AU - Zhou, Xiaojuan AU - Zhou, Laiyan AU - Yao, Zhuoran AU - Huang, Meijuan AU - Gong, Youling AU - Zou, Bingwen AU - Zhu, Jiang AU - Liu, Yongmei AU - Peng, Feng AU - Zhang, Yan AU - Yu, Min AU - Li, Yanying AU - Na, Feifei AU - Wu, Yijun AU - Kang, Kai AU - Xiu, Weigang AU - Zhang, Xuanwei AU - Zhou, Lin AU - Xu, Yong AU - Wang, Jin AU - Wang, Yan AU - Yang, Xue AU - Wu, Yuanjun AU - Li, Rui AU - Zhang, Yu AU - Yang, Zhenzhou AU - Zhou, Zhipeng AU - Bai, Jing AU - Yi, Xin AU - Tong, Ruizhan AU - Yin, Limei AU - Chen, Chong AU - Niedermann, Gabriele AU - Lu, You AU - Xue, Jianxin TI - 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. JO - Clinical cancer research VL - 29 IS - 20 SN - 1078-0432 CY - Philadelphia, Pa. [u.a.] PB - AACR M1 - DKFZ-2023-01663 SP - 4098-4108 PY - 2023 N1 - 2023 Oct 13;29(20):4098-4108 AB - 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 LB - PUB:(DE-HGF)16 C6 - pmid:37581611 DO - DOI:10.1158/1078-0432.CCR-23-0315 UR - https://inrepo02.dkfz.de/record/278582 ER -