PMID- 38362379
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240217
IS  - 1758-8340 (Print)
IS  - 1758-8359 (Electronic)
IS  - 1758-8340 (Linking)
VI  - 16
DP  - 2024
TI  - Efficacy and safety of raltitrexed-eluting CalliSpheres((R)) bead transarterial 
      chemoembolization in patients with intermediate-stage hepatocellular carcinoma: a 
      single-arm, prospective study.
PG  - 17588359241229661
LID - 10.1177/17588359241229661 [doi]
LID - 17588359241229661
AB  - BACKGROUND: The most common loadable chemotherapeutic drugs in drug-eluting bead 
      transarterial chemoembolization (DEB-TACE) include doxorubicin, epirubicin, etc. 
      CalliSpheres((R)) beads have exhibited efficient loadability and eluting 
      characteristics for raltitrexed as well as in vitro and animal experiments. 
      However, the efficacy and safety of raltitrexed-loaded DEB-TACE in patients with 
      intermediate-stage hepatocellular carcinoma (HCC) remain unclear. OBJECTIVES: To 
      assess the efficacy and safety of raltitrexed-loaded DEB-TACE in patients with 
      intermediate-stage HCC. DESIGN: The study was conducted as a single-arm 
      prospective study. METHODS: This study was a prospective, single-arm trial 
      conducted between June 2019 and June 2022. CalliSpheres((R)) beads loaded with 
      raltitrexed were used in the DEB-TACE procedure. The follow-up lasted for at 
      least 1 year or until death. The primary endpoint was overall survival (OS), and 
      the secondary endpoints were time to progression (TTP), progression-free survival 
      (PFS), objective response rate (ORR), and adverse events (AEs). RESULTS: The 
      6-month ORR and disease control rates were 90.1% and 93.8%, respectively. The 
      median OS was 33.0 months. The 1-, 2-, and 3-year survival rates were 95.1%, 
      82.1%, and 43.6%, respectively. Child-Pugh class and bilobar disease occurrence 
      were identified as independent OS predictors. The median TTP and PFS were 22.7 
      and 19.8 months, respectively. Eleven (11.5%) patients experienced at least one 
      grade 3 AE, and serious AEs were reported in five participants (5.2%). No patient 
      experienced grade 4 or 5 AEs. CONCLUSION: Raltitrexed-loaded DEB-TACE is 
      feasible, safe, and effective in patients with intermediate-stage HCC. TRIAL 
      REGISTRATION: This trial was registered at www.chictr.org.cn under the 
      identifier: 1900024097 on 25 June 2019.
CI  - (c) The Author(s), 2024.
FAU - Sun, Zhanguo
AU  - Sun Z
AUID- ORCID: 0000-0002-3718-0485
AD  - Department of Interventional Medicine, The First Affiliated Hospital of Zhengzhou 
      University, Zhengzhou, China.
FAU - Jiao, Dechao
AU  - Jiao D
AUID- ORCID: 0000-0002-5055-4672
AD  - Department of Interventional Medicine, The First Affiliated Hospital of Zhengzhou 
      University, No. 1 Jianshe East Road, Zhengzhou, Henan, China.
FAU - Fang, Yi
AU  - Fang Y
AD  - Department of Interventional Medicine, The First Affiliated Hospital of Zhengzhou 
      University, Zhengzhou, China.
FAU - Liu, Yiming
AU  - Liu Y
AD  - Department of Interventional Medicine, The First Affiliated Hospital of Zhengzhou 
      University, Zhengzhou, China.
FAU - Xu, Kaihao
AU  - Xu K
AD  - Department of Interventional Medicine, The First Affiliated Hospital of Zhengzhou 
      University, Zhengzhou, China.
FAU - Zhang, Chengzhi
AU  - Zhang C
AD  - Department of Interventional Medicine, The First Affiliated Hospital of Zhengzhou 
      University, Zhengzhou, China.
FAU - Huang, Yuanhao
AU  - Huang Y
AD  - Department of Interventional Medicine, Zhengzhou Central Hospital, Zhengzhou, 
      China.
FAU - Han, Xinwei
AU  - Han X
AD  - Department of Interventional Medicine, The First Affiliated Hospital of Zhengzhou 
      University, Zhengzhou, China.
LA  - eng
PT  - Journal Article
DEP - 20240214
PL  - England
TA  - Ther Adv Med Oncol
JT  - Therapeutic advances in medical oncology
JID - 101510808
PMC - PMC10868504
OAB - Efficacy and safety of raltitrexed-loaded DEB-TACE in patients with 
      intermediate-stage hepatocellular carcinoma The utility of raltitrexed-loaded 
      CalliSphere(R) beads in drug-eluting bead transarterial chemoembolization 
      (DEB-TACE) has been demonstrated in in vitro and animal experiments. However, its 
      efficacy and safety in patients with intermediate-stage hepatocellular carcinoma 
      (HCC) remain unclear. Hence, this study aimed to assess the efficacy and safety 
      profiles of DEB-TACE for such patients. We discovered that raltitrexed-loaded 
      DEB-TACE led to a 6-month ORR of 90.1%, a median OS of 33.0 months, a median TTP 
      of 22.7 months, and a median PFS of 19.8 months. The 1-, 2-, and 3-year survival 
      rates were 95.1%, 82.1%, and 43.6%, respectively. Factors such as Child-Pugh 
      class and bilobar disease occurrence were identified as independent predictors of 
      OS. The study also showed acceptable safety profiles, with a low incidence of 
      grade 3 adverse events and no grade 4 or 5 adverse events. The results indicated 
      that raltitrexed-eluting CalliSpheres(R) beads for TACE can be a viable option for 
      treating patients with intermediate-stage HCC.
OABL- eng
OTO - NOTNLM
OT  - DEB-TACE
OT  - beads
OT  - chemoembolization
OT  - hepatocellular carcinoma
OT  - raltitrexed
OT  - transarterial
COIS- The authors declare that there is no conflict of interest.
EDAT- 2024/02/16 06:43
MHDA- 2024/02/16 06:44
PMCR- 2024/02/14
CRDT- 2024/02/16 03:57
PHST- 2023/04/09 00:00 [received]
PHST- 2024/01/10 00:00 [accepted]
PHST- 2024/02/16 06:44 [medline]
PHST- 2024/02/16 06:43 [pubmed]
PHST- 2024/02/16 03:57 [entrez]
PHST- 2024/02/14 00:00 [pmc-release]
AID - 10.1177_17588359241229661 [pii]
AID - 10.1177/17588359241229661 [doi]
PST - epublish
SO  - Ther Adv Med Oncol. 2024 Feb 14;16:17588359241229661. doi: 
      10.1177/17588359241229661. eCollection 2024.