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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) diseasefree 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 36 th 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.
AIM: To demonstrate that containing heparanase inhibitor PI-88 at 160 mg / d is safe and promising in reducing hepatocellular carcinoma (HCC) recurrence for up to 3 years 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 RESULTS: Safety parameters and the following efficacy endpoints were investigated: (1) time to recurrence; (2) diseasefree 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 36 th percentile was postponed by 78%. The efficacy of the agent PI-88 at 250 mg / d (1) multiple tumors or a single tumor ≥ 2 cm; and (2) hepatitis B or C revealed that the presence of PI-88 at CONCLUSION: Administering PI-88 at 160 mg / d is a safe and well-tolerated treatment with 160 mg / d conferred the most significant survival advantage (56.8% improvement in disease-free survival, P = 0.045) tolerated dosage that may confer significant clinical benefits for patients with HCC.