PMID- 36733485
OWN - NLM
STAT- MEDLINE
DCOM- 20230206
LR  - 20230307
IS  - 1664-3224 (Electronic)
IS  - 1664-3224 (Linking)
VI  - 14
DP  - 2023
TI  - Safety and feasibility of toripalimab plus lenvatinib with or without 
      radiotherapy in advanced BTC.
PG  - 1084843
LID - 10.3389/fimmu.2023.1084843 [doi]
LID - 1084843
AB  - BACKGROUND: Toripalimab shows antitumor efficacy in cholangiocarcinoma. 
      Radiotherapy (RT) may enhance systemic responses of PD-1 inhibitors and 
      lenvatinib. This study was designed to assess the safety and feasibility of 
      toripalimab plus lenvatinib with or without RT in advanced BTC. METHODS: This 
      study involved 88 patients with advanced BTC receiving toripalimab plus 
      lenvatinib with or without RT from the clinical trials (NCT03892577). Propensity 
      score matching (PSM) (1:1) analysis was used to balance potential bias. The 
      overall survival (OS), progression-free survival (PFS), objective response rate 
      (ORR), and adverse events (AEs) were evaluated. RESULTS: After PSM, the final 
      analysis included 40 patients: 20 receiving toripalimab plus lenvatinib without 
      RT (NRT); 20 receiving toripalimab plus lenvatinib with RT. The AEs were more 
      frequent in the RT group than in the NRT group without treatment-associated 
      mortality. The addition of RT did not cause specific AEs. The median PFS was 
      significantly longer with RT (10.8 versus 4.6 months, p<0.001). The median OS was 
      13.7 months with RT versus 9.2 months in the NRT group (p=0.008). The ORR was 35% 
      (95% CI: 12.1-57.9) in the RT group versus 20% (95% CI: 0.8-39.2) in the NRT 
      group. CONCLUSIONS: The addition of RT may enhance the efficacy of toripalimab 
      plus lenvatinib. Toripalimab plus lenvatinib with RT have a good safety profile 
      without an increase in specific toxicities in advanced BTC patients.
CI  - Copyright (c) 2023 Wang, Zhang, Xue, Zhu, Wang, Zhang, Yang, Wang, Wang, Chao, Yang 
      and Zhao.
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), 
      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), 
      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), 
      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), 
      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), 
      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), 
      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), 
      Beijing, China.
FAU - Wang, Hao
AU  - Wang H
AD  - Department of Liver Surgery, Peking Union Medical College Hospital, Chinese 
      Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), 
      Beijing, China.
FAU - Wang, Shanshan
AU  - Wang S
AD  - Department of Liver Surgery, Peking Union Medical College Hospital, Chinese 
      Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), 
      Beijing, China.
FAU - Chao, Jiashuo
AU  - Chao J
AD  - Department of Liver Surgery, Peking Union Medical College Hospital, Chinese 
      Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), 
      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), 
      Beijing, China.
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), 
      Beijing, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT03892577
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230117
PL  - Switzerland
TA  - Front Immunol
JT  - Frontiers in immunology
JID - 101560960
RN  - EE083865G2 (lenvatinib)
RN  - 8JXN261VVA (toripalimab)
SB  - IM
MH  - Humans
MH  - Feasibility Studies
MH  - *Bile Duct Neoplasms
MH  - Bile Ducts, Intrahepatic
PMC - PMC9887048
OTO - NOTNLM
OT  - PD-1 inhibitor
OT  - advanced biliary tract cancer
OT  - lenvatinib
OT  - radiotherapy
OT  - synergic effect
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2023/02/04 06:00
MHDA- 2023/02/07 06:00
PMCR- 2023/01/01
CRDT- 2023/02/03 01:58
PHST- 2022/10/31 00:00 [received]
PHST- 2023/01/02 00:00 [accepted]
PHST- 2023/02/03 01:58 [entrez]
PHST- 2023/02/04 06:00 [pubmed]
PHST- 2023/02/07 06:00 [medline]
PHST- 2023/01/01 00:00 [pmc-release]
AID - 10.3389/fimmu.2023.1084843 [doi]
PST - epublish
SO  - Front Immunol. 2023 Jan 17;14:1084843. doi: 10.3389/fimmu.2023.1084843. 
      eCollection 2023.