PMID- 38001934
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231128
IS  - 2227-9059 (Print)
IS  - 2227-9059 (Electronic)
IS  - 2227-9059 (Linking)
VI  - 11
IP  - 11
DP  - 2023 Oct 30
TI  - Comparison of Efficacy and Safety of Anti-Programmed Cell Death-1 Antibody Plus 
      Lenvatinib and Chemotherapy as First-Line Therapy for Patients with Stage IV 
      Gallbladder Cancer: A Real-World Study in a Chinese Population.
LID - 10.3390/biomedicines11112933 [doi]
LID - 2933
AB  - Background: The present study aimed to evaluate and compare the efficacy and 
      safety of anti-programmed cell death protein 1 (anti-PD-1) antibody plus 
      lenvatinib (tyrosine kinase inhibitor) therapy and chemotherapy as the first-line 
      treatment to unresectable stage IV gallbladder cancer (GBC). Methods: We 
      retrospectively analyzed the clinical data of patients with stage IV GBC who 
      received chemotherapy or anti-PD-1 antibody combined with lenvatinib therapy at 
      our hospital from March 2018 to October 2022. Patients with previous antitumor 
      treatment were excluded. The overall survival (OS), progression-free survival 
      (PFS), objective response rate (ORR), disease control rate (DCR), and adverse 
      events (AEs) were assessed. Results: A total of 64 patients were enrolled, of 
      which 33 patients received chemotherapy (gemcitabine + cisplatin) in the 
      chemotherapy group, and 31 patients received anti-PD-1antibody (camrelizumab) 
      combined with lenvatinib therapy in the combined therapy group. The median OS was 
      12.00 months in the combined therapy group and 10.00 months in the chemotherapy 
      group (hazard ratio (HR), 0.57; 95% CI: 0.32-1.03; p < 0.05). The median PFS was 
      9.00 months in the combined therapy group and 6.00 months in the chemotherapy 
      group (HR, 0.46; 95% CI: 0.25-0.84; p < 0.01). The ORR was 54.84% and 39.39% in 
      the combined therapy and chemotherapy groups, respectively, and the difference 
      was not significant (p = 0.22). The DCR was 80.65% and 72.72% in the combined 
      therapy and chemotherapy groups, respectively (p = 0.46). One patient 
      successfully underwent radical surgery after 8 months of combined therapy and 
      achieved a pathological complete response. Furthermore, no patients experienced 
      AEs of hematologic toxic effects in the combined therapy group compared with the 
      chemotherapy group, demonstrating the advantage of the combined therapy. 
      Conclusions: Anti-PD-1 antibody combined with lenvatinib may be a potentially 
      effective and tolerable first-line treatment for unresectable stage IV GBC.
FAU - Wu, Tiantian
AU  - Wu T
AUID- ORCID: 0000-0002-5986-4319
AD  - Department of Hepatobiliary Surgery, Peking University International Hospital, 
      No. 1, Life Garden Road, Zhongguancun Life Science Garden, Changping District, 
      Beijing 102206, China.
FAU - Pu, Changsheng
AU  - Pu C
AD  - Department of Hepatobiliary Surgery, Peking University International Hospital, 
      No. 1, Life Garden Road, Zhongguancun Life Science Garden, Changping District, 
      Beijing 102206, China.
FAU - Wang, Qiang
AU  - Wang Q
AD  - Department of Hepatobiliary Surgery, Peking University International Hospital, 
      No. 1, Life Garden Road, Zhongguancun Life Science Garden, Changping District, 
      Beijing 102206, China.
FAU - Zhang, Keming
AU  - Zhang K
AD  - Department of Hepatobiliary Surgery, Peking University International Hospital, 
      No. 1, Life Garden Road, Zhongguancun Life Science Garden, Changping District, 
      Beijing 102206, China.
LA  - eng
GR  - YN2021QN01/Peking University International Hospital Research Funds/
GR  - YN2018ZD04/Peking University International Hospital Research Funds/
GR  - 2020-2-8021/Capital's Funds for Health Improvement and Research/
GR  - CXPJJH1200008-14/Clinical Program of the Chen Xiao-Ping Foundation for the 
      Development of Science and Technology of Hubei Province, China/
PT  - Journal Article
DEP - 20231030
PL  - Switzerland
TA  - Biomedicines
JT  - Biomedicines
JID - 101691304
PMC - PMC10669544
OTO - NOTNLM
OT  - anti-programmed cell death-1 antibody
OT  - chemotherapy
OT  - gallbladder cancer
OT  - targeted therapy
COIS- The authors declare that they have no competing interests.
EDAT- 2023/11/25 12:46
MHDA- 2023/11/25 12:47
PMCR- 2023/10/30
CRDT- 2023/11/25 01:07
PHST- 2023/09/23 00:00 [received]
PHST- 2023/10/25 00:00 [revised]
PHST- 2023/10/27 00:00 [accepted]
PHST- 2023/11/25 12:47 [medline]
PHST- 2023/11/25 12:46 [pubmed]
PHST- 2023/11/25 01:07 [entrez]
PHST- 2023/10/30 00:00 [pmc-release]
AID - biomedicines11112933 [pii]
AID - biomedicines-11-02933 [pii]
AID - 10.3390/biomedicines11112933 [doi]
PST - epublish
SO  - Biomedicines. 2023 Oct 30;11(11):2933. doi: 10.3390/biomedicines11112933.