Therapeutic efficacy of combination therapy with intra-arterial 5-fluorouracil and systemic pegylated interferon α-2b for advanced hepatocellular carcinoma with portal venous invasion.

Abstract

BACKGROUND:

The prognosis of advanced hepatocellular carcinoma (HCC) remains poor, particularly among patients with portal vein tumor thrombosis (PVTT). This study evaluated the efficacy of combined 5-fluorouracil and pegylated interferon (PEG-IFN) α-2b in patients with advanced HCC.

METHODS:

Subjects comprised 59 HCC patients with PVTT treated using subcutaneous administration of PEG-IFNα-2b (50-100 μg on day 1 of each week for 4 weeks) and intra-arterial infusion of 5-fluorouracil (250 mg/d for 5 hours on days 1-5 of each week for 4 weeks). One treatment cycle lasted 4 weeks. The current therapy was discontinued in patients with progressive disease (PD). For responses other than PD, treatment was repeated for ≥1 cycle. The primary efficacy endpoint was the objective early response rate. Secondary efficacy endpoints were progression-free survival (PFS) and overall survival.

RESULTS:

Objective early response rate was 73.0%. Cumulative PFS rates were 67.4% at 6 months, 30.2% at 12 months, 25.9% at 18 months, and 20.7% at 24 months. Median PFS was 9.7 months. Cumulative survival rates were 82.4% at 6 months, 73.6% at 12 months, 52.8% at 24 months, and 44.0% at 36 months. Median survival time was 29.9 months. All adverse reactions were controllable by temporary suspension of treatment. Serious complications and treatment-related deaths were not observed.

CONCLUSIONS:

Although a prospective randomized controlled trial using a larger population of patients with advanced HCC is needed to evaluate combination therapy with 5-fluorouracil and PEG-IFNα-2b, this new combination therapy may be useful for patients with advanced HCC.

• Authors: Kazuhiro Kasai, Akira Ushio, Yukiho Kasai, Kei Sawara, Yasuhiro Miyamoto, Kanta Oikawa, Hidekatsu Kuroda, Yasuhiro Takikawa, Kazuyuki Suzuki
• Journal: Cancer (Cancer) Vol. 118 Issue 13 Pg. 3302-10 (Jul 01 2012) ISSN: 1097-0142 [Electronic] United States
• PMID: 22072099 (Publication Type: Clinical Trial, Journal Article)
• Copyright: Copyright © 2011 American Cancer Society.

Chemical References

• Interferon alpha-2
• Interferon-alpha
• Recombinant Proteins
• Polyethylene Glycols
• peginterferon alfa-2b
• Fluorouracil

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Carcinoma, Hepatocellular (drug therapy, mortality, secondary)
• Female
• Fluorouracil (administration & dosage)
• Humans
• Infusions, Intra-Arterial
• Interferon alpha-2
• Interferon-alpha (administration & dosage)
• Liver Neoplasms (drug therapy, pathology)
• Male
• Middle Aged
• Polyethylene Glycols (administration & dosage)
• Portal Vein
• Prognosis
• Recombinant Proteins (administration & dosage)
• Survival Rate
• Venous Thrombosis (complications)