PMID- 35022908
OWN - NLM
STAT- MEDLINE
DCOM- 20220720
LR  - 20240426
IS  - 1432-0851 (Electronic)
IS  - 0340-7004 (Print)
IS  - 0340-7004 (Linking)
VI  - 71
IP  - 8
DP  - 2022 Aug
TI  - A real-world study of the efficacy and safety of anti-PD-1 antibodies plus 
      lenvatinib in patients with advanced gallbladder cancer.
PG  - 1889-1896
LID - 10.1007/s00262-021-03121-0 [doi]
AB  - BACKGROUND: Anti-PD-1 antibodies plus lenvatinib therapeutic regimens have 
      demonstrated a relatively high antitumor response in many solid cancers; however, 
      the efficacy and safety of anti-PD-1 antibodies plus lenvatinib in patients with 
      advanced gallbladder cancer (GBC) has not been reported. METHODS: Advanced GBC 
      patients who received anti-PD-1 antibodies plus lenvatinib were retrospectively 
      screened. Overall survival (OS), progression-free survival (PFS), objective 
      response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR), 
      PD-L1 expression and safety were evaluated to identify efficacy biomarkers. 
      RESULTS: A total of 31 GBC patients were included in this study. After a median 
      follow-up of 8 months and 23 deaths were observed. The median PFS was 5.0 months 
      (95% CI: 4.1-8.0 months), and the median OS was 11.3 months (95% CI: 
      7.5-20.9 months). Overall, the ORR was 32.3%, the DCR was 83.9%, and the CBR was 
      41.9%. Moreover, after treatment, 3 patients received conventional surgery, in 
      which 1 patient achieved a pathological complete response. All patients (100%) 
      experienced adverse events (AEs), and 58.1% of the patients experienced grade 3 
      AEs. The most commonly observed grade 3 AEs included fatigue (5/31, 16.1%), 
      decreased appetite (5/31, 16.1%), hypertension (4/31, 12.9%) and bilirubin 
      elevation (4/31, 12.9%). Subgroup analysis revealed that positive PD-L1 
      expression maybe associate with a longer PFS. CONCLUSION: Anti-PD-1 antibodies 
      plus lenvatinib represent an effective and tolerable therapy for patients with 
      advanced gallbladder cancer.
CI  - (c) 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, 
      part of Springer Nature.
FAU - Zuo, Bangyou
AU  - Zuo B
AD  - Department of Liver Surgery, State Key Laboratory of Complex Severe and Rare 
      Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical 
      Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
FAU - Yang, Xiaobo
AU  - Yang X
AD  - Department of Liver Surgery, State Key Laboratory of Complex Severe and Rare 
      Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical 
      Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
FAU - Yang, Xu
AU  - Yang X
AD  - Department of Liver Surgery, State Key Laboratory of Complex Severe and Rare 
      Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical 
      Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
FAU - Bian, Jin
AU  - Bian J
AD  - Department of Liver Surgery, State Key Laboratory of Complex Severe and Rare 
      Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical 
      Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
FAU - Long, Junyu
AU  - Long J
AD  - Department of Liver Surgery, State Key Laboratory of Complex Severe and Rare 
      Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical 
      Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
FAU - Wang, Dongxu
AU  - Wang D
AD  - Department of Liver Surgery, State Key Laboratory of Complex Severe and Rare 
      Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical 
      Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
FAU - Ning, Cong
AU  - Ning C
AD  - Department of Liver Surgery, State Key Laboratory of Complex Severe and Rare 
      Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical 
      Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
FAU - Wang, Yanyu
AU  - Wang Y
AD  - Department of Liver Surgery, State Key Laboratory of Complex Severe and Rare 
      Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical 
      Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
FAU - Xun, Ziyu
AU  - Xun Z
AD  - Department of Liver Surgery, State Key Laboratory of Complex Severe and Rare 
      Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical 
      Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
FAU - Wang, Yunchao
AU  - Wang Y
AD  - Department of Liver Surgery, State Key Laboratory of Complex Severe and Rare 
      Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical 
      Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
FAU - Lu, Xin
AU  - Lu X
AD  - Department of Liver Surgery, State Key Laboratory of Complex Severe and Rare 
      Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical 
      Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
FAU - Mao, Yilei
AU  - Mao Y
AD  - Department of Liver Surgery, State Key Laboratory of Complex Severe and Rare 
      Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical 
      Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
FAU - Sang, Xinting
AU  - Sang X
AD  - Department of Liver Surgery, State Key Laboratory of Complex Severe and Rare 
      Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical 
      Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China. 
      sangxt@pumch.cn.
FAU - Zhao, Haitao
AU  - Zhao H
AUID- ORCID: 0000-0002-3444-8044
AD  - Department of Liver Surgery, State Key Laboratory of Complex Severe and Rare 
      Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical 
      Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China. 
      ZhaoHT@pumch.cn.
LA  - eng
GR  - 2016YFE0107100/international science and technology cooperation programme/
GR  - L172055/natural science foundation of beijing municipality/
GR  - 7192158/natural science foundation of beijing municipality/
GR  - 3332018032/fundamental research funds for central universities of the central 
      south university/
PT  - Journal Article
DEP - 20220113
PL  - Germany
TA  - Cancer Immunol Immunother
JT  - Cancer immunology, immunotherapy : CII
JID - 8605732
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antineoplastic Agents, Immunological)
RN  - 0 (B7-H1 Antigen)
RN  - 0 (Phenylurea Compounds)
RN  - 0 (Quinolines)
RN  - EE083865G2 (lenvatinib)
SB  - IM
MH  - Antibodies, Monoclonal, Humanized/therapeutic use
MH  - *Antineoplastic Agents, Immunological/therapeutic use
MH  - B7-H1 Antigen/metabolism
MH  - *Gallbladder Neoplasms/drug therapy
MH  - Humans
MH  - Phenylurea Compounds
MH  - Quinolines
MH  - Retrospective Studies
PMC - PMC10991186
OTO - NOTNLM
OT  - Gallbladder cancer
OT  - Lenvatinib
OT  - PD-1
OT  - PD-L1 expression
COIS- The authors declare that they have no conflict of interest.
EDAT- 2022/01/14 06:00
MHDA- 2022/07/22 06:00
PMCR- 2022/01/13
CRDT- 2022/01/13 06:20
PHST- 2021/07/16 00:00 [received]
PHST- 2021/11/24 00:00 [accepted]
PHST- 2022/01/14 06:00 [pubmed]
PHST- 2022/07/22 06:00 [medline]
PHST- 2022/01/13 06:20 [entrez]
PHST- 2022/01/13 00:00 [pmc-release]
AID - 10.1007/s00262-021-03121-0 [pii]
AID - 3121 [pii]
AID - 10.1007/s00262-021-03121-0 [doi]
PST - ppublish
SO  - Cancer Immunol Immunother. 2022 Aug;71(8):1889-1896. doi: 
      10.1007/s00262-021-03121-0. Epub 2022 Jan 13.