131I-Labeled-Metuximab Plus Transarterial Chemoembolization in Combination Therapy for Unresectable Hepatocellular Carcinoma: Results from a Multicenter Phase IV Clinical Study.

Abstract

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.

• Authors: Jun Ma, Jian-Hua Wang
• Journal: Asian Pacific journal of cancer prevention : APJCP (Asian Pac J Cancer Prev) Vol. 16 Issue 17 Pg. 7441-7 ( 2015) ISSN: 2476-762X [Electronic] Thailand
• PMID: 26625741 (Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study)

Chemical References

• Antibodies, Monoclonal
• Antineoplastic Agents
• Iodine Radioisotopes
• Radiopharmaceuticals
• metuximab

Topics

• Adult
• Aged
• Aged, 80 and over
• Antibodies, Monoclonal (administration & dosage, adverse effects, therapeutic use)
• Antineoplastic Agents (administration & dosage, therapeutic use)
• Carcinoma, Hepatocellular (mortality, pathology, therapy)
• Chemoembolization, Therapeutic (adverse effects, methods)
• Combined Modality Therapy
• Female
• Humans
• Iodine Radioisotopes
• Liver Neoplasms (mortality, pathology, therapy)
• Male
• Middle Aged
• Radiopharmaceuticals (administration & dosage, therapeutic use)
• Survival Rate
• Treatment Outcome
• Young Adult