PMID- 36856834 OWN - NLM STAT- MEDLINE DCOM- 20230615 LR - 20240426 IS - 1432-0851 (Electronic) IS - 0340-7004 (Print) IS - 0340-7004 (Linking) VI - 72 IP - 7 DP - 2023 Jul TI - Effectiveness and safety of radiotherapy plus programmed death-1 inhibitors and lenvatinib in patients with advanced biliary tract carcinoma: a real-world study. PG - 2197-2204 LID - 10.1007/s00262-023-03399-2 [doi] AB - BACKGROUND: Radiotherapy (RT) may function synergistically with immunotherapy and targeted agents (TA). This study aimed to assess the effectiveness and safety of RT combined with programmed death-1 (PD-1) inhibitors and lenvatinib in patients with relapsed or refractory advanced biliary tract carcinoma (BTC). METHODS: This retrospective study included patients with relapsed or refractory advanced BTC who received RT combined with PD-1 inhibitors and lenvatinib at the Peking Union Medical College Hospital (PUMCH). Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and safety were evaluated. RESULTS: Thirty-one patients who received RT combined with PD-1 inhibitors and lenvatinib as a second- or later-line therapy were analyzed. RT sites were mainly distributed in the liver lesions (64.5%) and lymph nodes (58.1%). The ORR and DCR were 32.3% (10/31; 95% CI: 14.8-49.7) and 87.1% (27/31; 95% CI: 74.6-99.6), respectively. The median PFS (mPFS) and median OS (mOS) were 7.9 (95% CI: 7.1-8.7) and 11.7 (95% CI: 8.3-15.0) months, respectively. Subgroup analyses of this cohort included 12 and 19 patients who received concurrent and salvage (> 6 weeks after commencing PD-1 inhibitor therapy) RT, respectively. The salvage RT group had higher mOS (11.7 vs. 10.5; p = 0.75) and mPFS (7.9 vs. 6.9; p = 0.85) than the concurrent RT group; however, statistical significance was not reached. All patients experienced any-grade adverse events (AEs), and excessive PD-1 inhibitors or RT toxicity were not observed. CONCLUSIONS: RT, PD-1 inhibitors, and lenvatinib may be safely combined and have antitumor effectiveness in patients with advanced BTC. CI - (c) 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature. FAU - Wang, Yunchao AU - Wang Y AD - Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), No. 1, Shuaifuyuan, Dongcheng District, Beijing, China. FAU - Yang, Xiaobo AU - Yang X AD - Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), No. 1, Shuaifuyuan, Dongcheng District, Beijing, China. FAU - Wang, Yanyu AU - Wang Y AD - Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), No. 1, Shuaifuyuan, Dongcheng District, Beijing, China. FAU - Xue, Jingnan AU - Xue J AD - Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), No. 1, Shuaifuyuan, Dongcheng District, Beijing, China. FAU - Zhang, Nan AU - Zhang N AD - Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), No. 1, Shuaifuyuan, Dongcheng District, Beijing, China. FAU - Yang, Xu AU - Yang X AD - Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), No. 1, Shuaifuyuan, Dongcheng District, Beijing, China. FAU - Cong, Ning AU - Cong N AD - Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), No. 1, Shuaifuyuan, Dongcheng District, Beijing, China. FAU - Zhang, Junwei AU - Zhang J AD - Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), No. 1, Shuaifuyuan, Dongcheng District, Beijing, China. FAU - Zhu, Chengpei AU - Zhu C AD - Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), No. 1, Shuaifuyuan, Dongcheng District, Beijing, China. FAU - Zhang, Longhao AU - Zhang L AD - Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), No. 1, Shuaifuyuan, Dongcheng District, Beijing, China. FAU - Hou, Xiaorong AU - Hou X AD - Department of Radiation Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), No. 1, Shuaifuyuan, Dongcheng District, Beijing, China. hxr_pumch@163.com. FAU - Zhao, Haitao AU - Zhao H AD - Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), No. 1, Shuaifuyuan, Dongcheng District, Beijing, China. zhaoht@pumch.cn. LA - eng GR - 2021-1-I2M-003 and 2021-I2M-1-061/CAMS Innovation Fund for Medical Sciences (CIFMS)/ GR - Y-MSDZD2021-0213/CSCO-MSD Cancer Research Fund/ GR - Y-HR2019-0239, Y-HR2020MS-0415, Y-HR2020QN-0414/CSCO-hengrui Cancer Research Fund/ PT - Journal Article DEP - 20230301 PL - Germany TA - Cancer Immunol Immunother JT - Cancer immunology, immunotherapy : CII JID - 8605732 RN - EE083865G2 (lenvatinib) RN - 0 (Immune Checkpoint Inhibitors) RN - J27WDC343N (Mesothelin) SB - IM MH - Humans MH - Immune Checkpoint Inhibitors/adverse effects MH - Retrospective Studies MH - *Bile Duct Neoplasms MH - *Carcinoma MH - *Gastrointestinal Neoplasms MH - Mesothelin MH - *Biliary Tract PMC - PMC10992455 OTO - NOTNLM OT - Advanced biliary tract cancer OT - Concurrent radiotherapy OT - Lenvatinib OT - PD-1 inhibitors OT - Salvage radiotherapy COIS- The authors have no conflicts of interest to declare. EDAT- 2023/03/02 06:00 MHDA- 2023/06/15 06:41 PMCR- 2023/03/01 CRDT- 2023/03/01 11:15 PHST- 2022/09/11 00:00 [received] PHST- 2023/02/05 00:00 [accepted] PHST- 2023/06/15 06:41 [medline] PHST- 2023/03/02 06:00 [pubmed] PHST- 2023/03/01 11:15 [entrez] PHST- 2023/03/01 00:00 [pmc-release] AID - 10.1007/s00262-023-03399-2 [pii] AID - 3399 [pii] AID - 10.1007/s00262-023-03399-2 [doi] PST - ppublish SO - Cancer Immunol Immunother. 2023 Jul;72(7):2197-2204. doi: 10.1007/s00262-023-03399-2. Epub 2023 Mar 1.