Adjuvant heparanase inhibitor PI-88 therapy for hepatocellular carcinoma recurrence

作者：Liu Chun Jen; Chang Juliana; Lee Po Huang; Lin Deng Yn; Wu Cheng Chung; Jeng Long Bin; Lin Yih Jyh; Mok King Tong; Lee Wei Chen; Yeh Hong Zen; Ho Ming Chih; Yang Sheng Shun; Yang Mei Due; Yu Ming Chin; Hu Rey Heng; Peng Cheng Yuan; Lai Kuan Lang; Chang Stanley Shi Chung; Chen Pei Jer^*

来源：World Journal of Gastroenterology, 2014, 20(32): 11384-11393.

DOI：10.3748/wjg.v20.i32.11384

• Antiangiogenesis
• Antimetastasis
• Adjuvant therapy
• Disease-free survival
• Heparanase inhibitor
• Hepatocellular carcinoma
• PI-88
• Tumor recurrence

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. %26lt;br%26gt;METHODS: A total of 143 patients (83.1% of the 172 participants in the phase. 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. trial. Safety parameters and the following efficacy endpoints were investigated: (1) time to recurrence; (2) disease-free survival; and (3) overall survival. %26lt;br%26gt;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 %26gt;= 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. %26lt;br%26gt;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.

• 出版日期2014-8-28
• 单位长春大学