Table 2.

Treatment outcome after oncolytic adenovirus treatments in TIM-3 groups

Clinical parameter		TIM-3 decr. (n=9)	TIM-3 incr. (n=6)	Total (n=15)	Significance* (decr. vs incr.)
Treatment outcome		Patient, n (% of total)			P value
Marker response†	CR	1 (11.1)	0 (0.0)	1 (6.7)	ns
	PR	0 (0.0)	2 (33.3)	2 (13.3)	ns
	MR	2 (22.2)	0 (0.0)	2 (13.3)	ns
	SD	2 (22.2)	0 (0.0)	2 (13.3)	ns
	PD	2 (22.2)	3 (50.0)	5 (33.3)	ns
	N/A	2 (22.2)	1 (16.7)	3 (20.0)	ns
Imaging response†	CR	0 (0.0)	0 (0.0)	0 (0.0)	ns
	PR	0 (0.0)	0 (0.0)	0 (0.0)	ns
	MR	3 (33.3)	1 (16.7)	4 (26.7)	ns
	SD	2 (22.2)	1 (16.7)	3 (20.0)	ns
	PD	2 (22.2)	1 (16.7)	3 (20.0)	ns
	N/A	2 (22.2)	3 (50.0)	5 (33.3)	ns
Overall survival	Median	204 days	64 days	143 days	‡	(0.0036)
	95% CI	(116 to 292 days)	(0 to 144 days)	(89 to 197 d)

*Patients were stratified into TIM-3 decr. and TIM-3 incr. groups based on direction of TIM-3 expression change. Fisher’s exact test was used for categorical response variables between TIM-3 groups, while log-rank test was used for overall survival.

†PET criteria were used to assess results of PET-CT imaging and tumor markers were measured from blood samples, both scored with the same percentage cutoffs, as described in the Materials and Methods section and online supplemental table S1.

‡P<0.01.

CR, complete response; decr., decrease; incr., increase; MR, minor response; ns, not significant; PD, progressive disease; PET, positron emission tomography; PR, partial response; SD, stable disease; TIM-3, T-cell immunoglobulin and mucin domain-3.