Ontology highlight
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.
SUBMITTER: Liu CJ
PROVIDER: S-EPMC4145780 | biostudies-literature | 2014 Aug
REPOSITORIES: biostudies-literature
Liu Chun-Jen CJ Chang Juliana J Lee Po-Huang PH Lin Deng-Yn DY Wu Cheng-Chung CC Jeng Long-Bin LB Lin Yih-Jyh YJ Mok King-Tong KT Lee Wei-Chen WC Yeh Hong-Zen HZ Ho Ming-Chih MC Yang Sheng-Shun SS Yang Mei-Due MD Yu Ming-Chin MC Hu Rey-Heng RH Peng Cheng-Yuan CY Lai Kuan-Lang KL Chang Stanley Shi-Chung SS Chen Pei-Jer PJ
World journal of gastroenterology 20140801 32
<h4>Aim</h4>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.<h4>Methods</h4>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 a ...[more]