|Title:||Adjuvant heparanase inhibitor PI-88 therapy for hepatocellular carcinoma recurrence||Authors:||CHUN-JEN LIU
|Issue Date:||2014||Publisher:||WJG Press||Journal Volume:||20||Journal Issue:||32||Start page/Pages:||11381-11393||Source:||World Journal of Gastroenterology||Abstract:||
AIM: To demonstrate that administering heparanase inhibitor PI-88 at 160 mg/d is safe and promising in reducing hepatocellular carcinoma (HCC) recurrence for up to 3 year following curative resection. METHODS: A total of 143 patients (83.1% of the 172 participants in the phase II study) participated in the follow-up study. Of these patients, 50 had received no treatment, 48 had received 160 mg/d PI-88, and 45 had received 250 mg/d PI-88 during the phase II trial. Safety parameters and the following efficacy endpoints were investigated: (1) time to recurrence; (2) disease-free survival; and (3) overall survival. RESULTS: PI-88 at 160 mg/d delayed the onset and frequency of HCC recurrence, and provided a clinically significant survival advantage for up to 3 years after treatment compared with those of the control group: (1) the recurrence-free rate increased from 50% to 63%, and (2) time to recurrence at the 36th percentile was postponed by 78%. The efficacy of administering PI-88 at 250 mg/d was confounded by a high dropout rate (11 out of 54 patients). Additionally, subgroup analyses of patients with (1) multiple tumors or a single tumor ? 2 cm; and (2) hepatitis B or C revealed that administering PI-88 at 160 mg/d conferred the most significant survival advantage (56.8% improvement in disease-free survival, P = 0.045) for patients with both risk factors for recurrence. CONCLUSION: Administering PI-88 at 160 mg/d is a safe and well-tolerated dosage that may confer significant clinical benefits for patients with HCC. ? 2014 Baishideng Publishing Group Inc. All rights reserved.
|ISSN:||1007-9327||DOI:||10.3748/wjg.v20.i32.11384||metadata.dc.subject.other:||muparfostat; antineoplastic agent; beta glucuronidase; enzyme inhibitor; heparanase; oligosaccharide; phosphomannopentaose sulfate; adult; aged; aminotransferase blood level; Article; bleeding; cancer adjuvant therapy; cancer recurrence; controlled study; disease free survival; drug efficacy; drug safety; female; follow up; hepatitis B; hepatitis C; human; injection site pain; liver cell carcinoma; major clinical study; male; multiple cancer; multiple cycle treatment; neutropenia; overall survival; partial thromboplastin time; patient compliance; phase 2 clinical trial; randomized controlled trial; recurrence free survival; adjuvant chemotherapy; antagonists and inhibitors; Carcinoma, Hepatocellular; clinical trial; drug administration; enzymology; Liver Neoplasms; metabolism; middle aged; mortality; multicenter study; pathology; risk factor; survival; Taiwan; time; treatment outcome; Adult; Aged; Antineoplastic Agents; Carcinoma, Hepatocellular; Chemotherapy, Adjuvant; Disease-Free Survival; Drug Administration Schedule; Enzyme Inhibitors; Female; Glucuronidase; Humans; Liver Neoplasms; Male; Middle Aged; Oligosaccharides; Risk Factors; Survival Analysis; Taiwan; Time Factors; Treatment Outcome
|Appears in Collections:||臨床醫學研究所|
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