PMID- 26625741
OWN - NLM
STAT- MEDLINE
DCOM- 20160926
LR  - 20220311
IS  - 2476-762X (Electronic)
IS  - 1513-7368 (Linking)
VI  - 16
IP  - 17
DP  - 2015
TI  - 131I-Labeled-Metuximab Plus Transarterial Chemoembolization in Combination 
      Therapy for Unresectable Hepatocellular Carcinoma: Results from a Multicenter 
      Phase IV Clinical Study.
PG  - 7441-7
AB  - OBJECTIVE: This study evaluated the safety and objective response of combining 
      131I-labeled-metuximab (Licartin) with transarterial chemoembolization (TACE) in 
      the treatment of unresectable hepatocellular carcinoma (HCC). MATERIALS AND 
      METHODS: In a multicenter open-label clinical trial, 341 enrolled patients with 
      stage III/IV HCC according to TNM criteria were nonrandomly assigned to a trial 
      group (n=167) and a control group (n=174), undergoing TACE following hepatic 
      intra-arterial injection of licartin or TACE alone from July 2007 to July 2009. 
      Radiopharmaceutical distribution was evaluated. The primary endpoint was overall 
      survival; secondary endpoints included time-to-progression (TTP), toxicity and 
      adverse events (AEs). RESULTS: The radiobiological distribution demonstrated 
      better localization of licartin in liver tumors than other tissues (P<0.01). The 
      organ absorbed doses to liver and red marrow were 3.19 +/- 1.01 Gy and 0.55 +/- 0.22 
      Gy, respectively. The 1-year survival rate was significantly higher [79.47% vs. 
      65.59%, hazard ratio (HR), 0.598, P=0.041] and TTP significantly improved (6.82 +/- 
      1.28 vs. 4.7 +/- 1.14 months, P=0.037) compared with the control group. Patients at 
      stage III achieved more benefit of one year survival than stage IV in the trial 
      group (86.9% vs. 53.8%, P<0.001). There were significant different toxicities in 
      leukocytopenia, thrombocytopenia and increased total bilirubin level [P<0.001, 
      P=0.013, P<0.01, relative risk (RR) 1.63, 1.33, 1.43], but no differences in 
      severe AEs of upper GI hemorrhage and severe liver dysfunction between the groups 
      (5.39% vs. 2.3%, P=0.136). CONCLUSIONS: Owing to excellent tumor-targeting, 
      promised efficacy and favourable toxicity profile, the novel combination therapy 
      of licartin and TACE could be applied in patients with unresectable HCC.
FAU - Ma, Jun
AU  - Ma J
AD  - Department of Interventional Radiology, Zhongshan Hospital, Fudan University, 
      Shanghai, China E-mail : jhdoccn@163.com.
FAU - Wang, Jian-Hua
AU  - Wang JH
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PL  - Thailand
TA  - Asian Pac J Cancer Prev
JT  - Asian Pacific journal of cancer prevention : APJCP
JID - 101130625
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Iodine Radioisotopes)
RN  - 0 (Radiopharmaceuticals)
RN  - 0 (metuximab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal/administration & dosage/adverse effects/*therapeutic use
MH  - Antineoplastic Agents/administration & dosage/*therapeutic use
MH  - Carcinoma, Hepatocellular/mortality/pathology/*therapy
MH  - Chemoembolization, Therapeutic/adverse effects/*methods
MH  - Combined Modality Therapy
MH  - Female
MH  - Humans
MH  - Iodine Radioisotopes
MH  - Liver Neoplasms/mortality/pathology/*therapy
MH  - Male
MH  - Middle Aged
MH  - Radiopharmaceuticals/administration & dosage/*therapeutic use
MH  - Survival Rate
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2015/12/03 06:00
MHDA- 2016/09/27 06:00
CRDT- 2015/12/03 06:00
PHST- 2015/12/03 06:00 [entrez]
PHST- 2015/12/03 06:00 [pubmed]
PHST- 2016/09/27 06:00 [medline]
AID - 10.7314/apjcp.2015.16.17.7441 [doi]
PST - ppublish
SO  - Asian Pac J Cancer Prev. 2015;16(17):7441-7. doi: 10.7314/apjcp.2015.16.17.7441.