Adjuvant heparanase inhibitor PI-88 therapy for hepatocellular carcinoma recurrence

Table 6 Subgroup analyses comparing disease-free survival probabilities of the 160 mg/d group to their respective controls in the phase II and follow-up studies

Subgroup analyses	Phase II study		3-yr study
	Week 48		Week 156
	Group A untreated	Group B 160 mg/d	Group A untreated	Group B 160 mg/d
Study cohort
DFS probability	54.1%	68.4%	38.5%	49.4%
Difference		14.3%		10.8%
95%CI		-3.4-32.0		-7.3-29.0
Rate of improvement1		26.4%		28.1%
P value2		0.129		0.257
Intermediate-risk group (multiple or single tumor ≥ 2 cm)
DFS probability	45.1%	63.8%	33.0%	48.4%
Difference		18.7%		15.4%
95%CI		-0.8-38.2		-3.9-34.7
Rate of improvement		41.5%		46.6%
P value		0.104		0.150
High-risk group (multiple or single tumor ≥ 2 cm and positive HBV/HCV infection)3
DFS probability	41.4%	64.9%	29.6%	46.4%
Difference		23.5%		16.8%
95%CI		2.0-45.0		-4.4-38.1
Rate of improvement		56.8%		56.8%
P value		0.045		0.163

^1,2 Table 3 footnote 2 and 3;

³ Values from Figure 3. The clinical benefits of 160 mg/d PI-88 were more pronounced in intermediate and high-risk groups. Statistically significant survival benefits were observed in the high-risk group at the end of the phase II study. TTR: Time-to-recurrence; DFS: Disease-free survival; OS: Overall survival; HBV: Hepatitis B virus; HCV: Hepatitis C virus.