PMID- 34670506
OWN - NLM
STAT- MEDLINE
DCOM- 20220128
LR  - 20220128
IS  - 1471-2407 (Electronic)
IS  - 1471-2407 (Linking)
VI  - 21
IP  - 1
DP  - 2021 Oct 19
TI  - Pembrolizumab plus lenvatinib with or without hepatic arterial infusion 
      chemotherapy in selected populations of patients with treatment-naive 
      unresectable hepatocellular carcinoma exhibiting PD-L1 staining: a multicenter 
      retrospective study.
PG  - 1126
LID - 10.1186/s12885-021-08858-6 [doi]
LID - 1126
AB  - BACKGROUND: Not all patients with unresectable hepatocellular carcinoma (uHCC) 
      benefit from treatment with immune checkpoint inhibitors and molecular-targeted 
      agents. The aim of this retrospective study was to assess the efficacy and safety 
      of pembrolizumab plus lenvatinib plus hepatic arterial infusion chemotherapy 
      (HAIC) versus pembrolizumab plus lenvatinib in selected populations of patients 
      with treatment-naive uHCC exhibiting programmed cell death ligand-1 (PD-L1) 
      staining. METHODS: Consecutive patients with treatment-naive uHCC exhibiting 
      PD-L1 staining who were treated with pembrolizumab plus lenvatinib plus HAIC 
      (PLH) or pembrolizumab plus lenvatinib (PL) were retrospectively identified from 
      our medical centres from 2018 to 2021. HAIC involved oxaliplatin, fluorouracil, 
      and leucovorin (FOLFOX). Follow-up occurred every 3 weeks for 1 year and then 
      every 6 weeks thereafter. The primary endpoints included overall survival (OS) 
      and progression-free survival (PFS). Secondary endpoints were the frequency of 
      key adverse events (AEs). RESULTS: In total, 248 treatment-naive patients were 
      retrospectively reviewed, 78 of whom were ineligible on the basis of the current 
      criteria. Thus, 170 patients (PLH: n = 84, median age 52 years [range, 42-67]; 
      PL: n = 86, 53 years [range, 43-69]) were eligible for the analysis. The median 
      follow-up was 18.6 months (range, 1-26). At the final follow-up, the median OS 
      was 17.7 months (95% confidence interval [CI], 15.2-18.3) in the PLH group versus 
      12.6 months (95% CI, 11.1-13.7) in the PL group (hazard ratio [HR] 0.52; 95% CI, 
      0.36-0.75; p = 0.001). A significant difference was also detected in the median 
      PFS (10.9 months [95% CI, 8.7-11.4] for PLH vs. 6.8 months (95% CI, 5.2-7.4) for 
      PL; HR 0.61, 95% CI, 0.43-0.85; p = 0.001). Significant differences in the rate 
      of the key AEs were noted between groups (79.8% for PLH vs. 62.8% for PL, 
      p = 0.015), but these AEs were controllable. CONCLUSIONS: Among selected 
      populations of patients with treatment-naive uHCC exhibiting PD-L1 staining, the 
      PLH regimen may substantially improve the survival benefits compared with the PL 
      regimen with a controllable safety profile.
CI  - (c) 2021. The Author(s).
FAU - Chen, Song
AU  - Chen S
AD  - Department of Invasive Technology, The First Affiliated Hospital, Sun Yat-sen 
      University, No. 58, Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, 
      China.
FAU - Xu, Bo
AU  - Xu B
AD  - Department of Cardiothoracic Surgery, The First Affiliated Hospital, Sun Yat-sen 
      University, No. 58, Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, 
      China.
FAU - Wu, Zhiqiang
AU  - Wu Z
AD  - Department of Invasive Technology, The First Affiliated Hospital, Sun Yat-sen 
      University, No. 58, Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, 
      China.
FAU - Wang, Pengfei
AU  - Wang P
AD  - Department of Emergency Medicine, The Sun Yat-sen Memorial Hospital of Sun 
      Yat-sen University, No. 107, Yanjiang West Road, Haizhu District, Guangzhou, 
      510120, China.
FAU - Yu, Weiguang
AU  - Yu W
AD  - Department of Orthopedics, The First Affiliated Hospital, Sun Yat-sen University, 
      No. 58, Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, China. 
      yuwg3@mail.sysu.edu.cn.
FAU - Liu, Zhiyong
AU  - Liu Z
AD  - Department of Oncology, Henan Provincial Tumor Hospital, The Affiliated Cancer 
      Hospital of Zhengzhou University, No. 127, Dongming Road, Jinshui District, 
      Zhengzhou, 450003, China.
FAU - Huang, Xiaoyong
AU  - Huang X
AD  - Department of Hepatic Surgery, Zhongshan Hospital, Fudan University, No. 180, 
      Fenglin Road, Xuhui District, Shanghai, 20032, China.
FAU - Wu, Yanqing
AU  - Wu Y
AD  - Department of Thyroid Breast Surgery, The First Affiliated Hospital, Sun Yat-sen 
      University, No. 58, Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, 
      China.
FAU - Li, Tengfei
AU  - Li T
AD  - Department of Cardiology, The First Affiliated Hospital, Sun Yat-sen University, 
      No. 58, Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, China. 
      litengfei@mail.sysu.edu.cn.
FAU - Guo, Wenbo
AU  - Guo W
AD  - Department of Invasive Technology, The First Affiliated Hospital, Sun Yat-sen 
      University, No. 58, Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, 
      China. guowenbo@mail.sysu.edu.cn.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20211019
PL  - England
TA  - BMC Cancer
JT  - BMC cancer
JID - 100967800
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (B7-H1 Antigen)
RN  - 0 (CD274 protein, human)
RN  - 0 (Organoplatinum Compounds)
RN  - 0 (Phenylurea Compounds)
RN  - 0 (Quinolines)
RN  - 04ZR38536J (Oxaliplatin)
RN  - DPT0O3T46P (pembrolizumab)
RN  - EE083865G2 (lenvatinib)
RN  - Q573I9DVLP (Leucovorin)
RN  - U3P01618RT (Fluorouracil)
RN  - Folfox protocol
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage
MH  - Antineoplastic Agents/*administration & dosage
MH  - Antineoplastic Combined Chemotherapy Protocols/administration & dosage
MH  - B7-H1 Antigen/analysis
MH  - Carcinoma, Hepatocellular/chemistry/*drug therapy/mortality/pathology
MH  - Female
MH  - Fluorouracil/administration & dosage
MH  - Humans
MH  - Infusions, Intra-Arterial/methods
MH  - Leucovorin/administration & dosage
MH  - Liver Neoplasms/chemistry/*drug therapy/mortality/pathology
MH  - Male
MH  - Middle Aged
MH  - Organoplatinum Compounds/administration & dosage
MH  - Oxaliplatin/administration & dosage
MH  - Phenylurea Compounds/*administration & dosage
MH  - Progression-Free Survival
MH  - Quinolines/*administration & dosage
MH  - Retrospective Studies
PMC - PMC8527794
OTO - NOTNLM
OT  - Hepatic arterial infusion chemotherapy
OT  - Hepatocellular carcinoma
OT  - Lenvatinib
OT  - Pembrolizumab
OT  - Survival
COIS- The authors declare that there is no conflict of interest.
EDAT- 2021/10/22 06:00
MHDA- 2022/01/29 06:00
PMCR- 2021/10/19
CRDT- 2021/10/21 05:29
PHST- 2021/05/03 00:00 [received]
PHST- 2021/10/05 00:00 [accepted]
PHST- 2021/10/21 05:29 [entrez]
PHST- 2021/10/22 06:00 [pubmed]
PHST- 2022/01/29 06:00 [medline]
PHST- 2021/10/19 00:00 [pmc-release]
AID - 10.1186/s12885-021-08858-6 [pii]
AID - 8858 [pii]
AID - 10.1186/s12885-021-08858-6 [doi]
PST - epublish
SO  - BMC Cancer. 2021 Oct 19;21(1):1126. doi: 10.1186/s12885-021-08858-6.