Table 2.

Patient demographics

		GTE
	Placebo (n=11)	500 mg/m2 (n=11)	750 mg/m2 (n=9)	1000 mg/m2 (n=10)	Total (n=41)
Median age (range)	57(33–76)	57(35–71)	49(41–71)	59(36–70)	57(33–76)
Gender, n (%)
Male	6 (54.5%)	5 (45.5%)	4 (44.4%)	4 (40%)	19 (46.3%)
Female	5 (45.5%)	6 (45.5%)	5 (55.6%)	6 (60%)	22 (53.7%)
Ethnicity, n (%)
Caucasian	11(100%)	10 (90.9%)	8 (88.9%)	8 (80%)	37 (90.2%)
Asian	0	1(9.1%)	1(11.1%)	0	2 (4.9%)
Hispanic	0	0	0	2 (20%)	2 (4.9%)
Smoking Status, n (%)
Never smoked	4 (36.4%)	4 (36.4%)	3 (33.3%)	4 (40%)	15 (36.6%)
Former smoker	6 (54.5%)	6 (54.5%)	5 (55.6%)	5 (50%)	22 (53.7%)
Current smoker	1 (9.1%)	1(9.1%)	1(11.1%)	1 (10%)	4 (9.8%)
Cigar use
Former	1(9.1%)	0	0	0	1 (2.4%)
Current	0	2 (18.2%)	0	1 (10%)	3 (7.3%)
Smokeless Tobacco
Former	1(9.1%)	0	0	0	1 (2.4%)
Current	0	0	0	0	0
Alcohol Status, n (%)
Never	2 (18.2%)	1(9.1%)	2 (22.2%)	3 (30%)	8 (19.5%)
Former	2 (18.2%)	3 (27.3%)	2 (22.2%)	2 (20%)	9 (22%)
Current	7 (63.6%)	7 (63.6%)	5 (55.6%)	5 (50%)	24 (58.5%)
Prior cancer history, n (%)
HNSCC	3 (27.3%)	4 (36.4%)	3 (33.3%)	4 (40%)	14(34.1%)
Other	1 (9.1%)	1(9.1%)	1(11.1%)	3 (30%)	6 (14.6%)
Prior treatment, n (%)
No prior radiotherapy	10 (90.9%)	10 (90.9%)	9 (100%)	7 (70%)	36 (87.8%)
No prior surgery	3 (27.3%)	0	1(11.1%)	0	4 (9.8%)
Prior radiotherapy	1 (9.1%)	1 (9.1%)	0	3 (30%)	5 (12.2%)
Prior surgery	8 (72.7%)	11(100%)	8 (88.9%)	10 (100%)	37 (90.2%)
Baseline histology, n (%)
Hyperplasia	5 (45.5%)	2 (18.2%)	2 (22.2%)	2 (20%)	11(26.8%)
Mild dysplasia	5 (45.5%)	5 (45.5%)	7 (77.8%)	6 (60%)	23 (56.1%)
Moderate dysplasia/-carcinoma in situ	1 (9.1%)	4 (36.4%)	0	2 (20%)	7(17.1%)