PMID- 38196538
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240111
IS  - 2078-6891 (Print)
IS  - 2219-679X (Electronic)
IS  - 2078-6891 (Linking)
VI  - 14
IP  - 6
DP  - 2023 Dec 31
TI  - Efficacy and safety of regorafenib as second-line treatment for patients with 
      hepatocellular carcinoma and macrovascular invasion and(or) extrahepatic 
      metastasis.
PG  - 2536-2548
LID - 10.21037/jgo-23-651 [doi]
AB  - BACKGROUND: Macrovascular invasion and(or) extrahepatic metastasis are the main 
      clinical characteristics of Chinese patients with hepatocellular carcinoma (HCC) 
      after entering the second-line treatment. The aim of this study was to explore 
      the efficacy and safety of regorafenib as a second-line treatment for these 
      patients with HCC. METHODS: We selected 253 patients with primary liver cancer 
      who were treated in Henan Cancer Hospital from June 2017 to September 2020. 
      According to the inclusion and exclusion criteria, 63 patients with HCC with 
      macrovascular invasion and/or extrahepatic metastasis were finally included. The 
      clinical data of patients were obtained by consulting the electronic medical 
      record system and through telephone follow-up. The median overall survival (mOS), 
      duration of drug use, and disease control rate (DCR) of patients were evaluated, 
      and the Cox regression model was used to analyze the risk factors of prognosis. 
      RESULTS: The mOS of 63 patients with HCC administered regorafenib as second-line 
      treatment was 9.6 months, the duration of drug use was 3.8 months, and the DCR 
      was 59% (37/63). Cox multivariate analysis showed that overall survival (OS) was 
      closely related to the level of alpha-fetoprotein (AFP) and treatment method but 
      not to the type of first-line drug. The mOS of patients with AFP >/=400 ng/mL was 
      7.4 months, which was significantly lower than that of those with AFP <400 ng/mL 
      (12.5 months) (P=0.0052). The mOS of patients treated with regorafenib alone was 
      6.8 months, which was significantly lower than that of those treated with 
      regorafenib combined with immunotherapy (24.3 months) and intervention therapy 
      (17.5 months) (P<0.0001). The mOS of patients using regorafenib as second-line 
      treatment in the first-line sorafenib group and first-line nonsorafenib group 
      were 9.5 and 9.6 months, respectively (P=0.9766). The grade >/=3 adverse events 
      (AEs) with an incidence of more than 10% included hand-foot syndrome, increased 
      bilirubin, decreased albumin, and elevated transaminase, with incidences of 22%, 
      14%, 11%, and 10%, respectively. CONCLUSIONS: As second-line treatment for 
      patients with HCC with macrovascular invasion and(or) extrahepatic metastasis, 
      regorafenib has definite efficacy and tolerable adverse reactions. It is the 
      preferred drug for the second-line treatment of patients with advanced HCC.
CI  - 2023 Journal of Gastrointestinal Oncology. All rights reserved.
FAU - Zhao, Yan
AU  - Zhao Y
AD  - Department of Medical Oncology, The Affiliated Cancer Hospital of Zhengzhou 
      University & Henan Cancer Hospital, Zhengzhou, China.
FAU - Liu, Weiling
AU  - Liu W
AD  - Department of Medical Oncology, The Affiliated Cancer Hospital of Zhengzhou 
      University & Henan Cancer Hospital, Zhengzhou, China.
FAU - Zheng, Lu
AU  - Zheng L
AD  - Department of Medical Oncology, The Affiliated Cancer Hospital of Zhengzhou 
      University & Henan Cancer Hospital, Zhengzhou, China.
FAU - Goyal, Sharad
AU  - Goyal S
AD  - Department of Radiation Oncology, George Washington University, Washington, DC, 
      USA.
FAU - Awosika, Joy
AU  - Awosika J
AD  - National Institutes of Health, National Cancer Institute, Bethesda, MD, USA.
FAU - Wang, Hailing
AU  - Wang H
AD  - Department of Medical Oncology, The Affiliated Cancer Hospital of Zhengzhou 
      University & Henan Cancer Hospital, Zhengzhou, China.
FAU - Yang, Shujun
AU  - Yang S
AD  - Department of Medical Oncology, The Affiliated Cancer Hospital of Zhengzhou 
      University & Henan Cancer Hospital, Zhengzhou, China.
LA  - eng
PT  - Journal Article
DEP - 20231121
PL  - China
TA  - J Gastrointest Oncol
JT  - Journal of gastrointestinal oncology
JID - 101557751
PMC - PMC10772694
OTO - NOTNLM
OT  - Hepatocellular carcinoma (HCC)
OT  - extrahepatic metastasis
OT  - macrovascular invasion
OT  - regorafenib
COIS- Conflicts of Interest: All authors have completed the ICMJE uniform disclosure 
      form (available at 
      https://jgo.amegroups.com/article/view/10.21037/jgo-23-651/coif). S.G. serves as 
      the Chair of DSMB, Imaging and Radiation Therapy Committee, Center for Cancer 
      Research @ NCI. He holds leadership position on Advances in Radiation Oncology. 
      He is in Editorial Board of The Breast Journal and Frontiers in Radiation 
      Oncology. No payments were made to Sharad Goyal. The other authors have no 
      conflicts of interest to declare.
EDAT- 2024/01/10 06:41
MHDA- 2024/01/10 06:42
PMCR- 2023/12/31
CRDT- 2024/01/10 03:36
PHST- 2023/08/05 00:00 [received]
PHST- 2023/10/12 00:00 [accepted]
PHST- 2024/01/10 06:42 [medline]
PHST- 2024/01/10 06:41 [pubmed]
PHST- 2024/01/10 03:36 [entrez]
PHST- 2023/12/31 00:00 [pmc-release]
AID - jgo-14-06-2536 [pii]
AID - 10.21037/jgo-23-651 [doi]
PST - ppublish
SO  - J Gastrointest Oncol. 2023 Dec 31;14(6):2536-2548. doi: 10.21037/jgo-23-651. Epub 
      2023 Nov 21.