Adjuvant heparanase inhibitor PI-88 therapy for hepatocellular carcinoma recurrence

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

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52 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)11381-11393
Number of pages13
JournalWorld journal of gastroenterology
Issue number32
Publication statusPublished - 2014 Aug 28

All Science Journal Classification (ASJC) codes

  • Gastroenterology


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