Adjuvant heparanase inhibitor PI-88 therapy for hepatocellular carcinoma recurrence

Table 5 Summary of time-to-recurrence, disease-free survival probability, and overall survival results from the follow-up study n (%)

Probability	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
TTR probability1	45.9%	29.8%	61.5%	48.1%
Difference		-16.1%		-13.4%
95%CI		-33.6-1.5		-31.5-4.7
Rate of improvement2		35.1%		21.8%
P value3		0.086		0.187
DFS probability4	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 improvement		26.4%		28.1%
P value		0.129		0.257
OS probability	90.9%	88.6%	81.0%	82.8%
Difference		-2.3%		1.7%
95%CI		-13.4-8.8		-12.4-15.9
Rate of improvement		-2.5%		2.2%
P value		0.760		1.000

^1,4Values from Figure 2 respectively;

²Percent change in endpoint probability of treated group from untreated control;

³Fisher’s exact test. Although not statistically significant, time-to-recurrence (TTR) and disease-free survival (DFS) probabilities and rates of improvements in the 160 mg/d group indicate substantial clinical advantages. Similarities in the two rates of DFS improvement indicate that the clinical benefits of 36 wk of treatment with 160 mg/d PI-88 persisted for up to 3 years. Despite the clinical survival benefits indicated by DFS, overall survival (OS) benefits were inconclusive.