Table 1.

Patient characteristics for samples tested for p16 and human papillomavirus

	HPV			p16
	Negative (n = 53)	Positive (n = 11)	P-value	Negative (n = 53)	Positive (n = 12)	P-value
Age, median (range)	65 (43, 85)	59 (47, 80)	0.61	64 (43, 85)	61.5 (47, 80)	0.97
Treatment
E1395: cisplatin + 5-FU	11 (21%)	4 (36%)	0.44	11 (21%)	4 (33%)	0.70
E1395: paclitaxel + cisplatin	17 (32%)	2 (18%)		16 (30%)	3 (25%)
E3301: docetaxel + irinotecan	25 (47%)	5 (45%)		26 (49%)	5 (42%)
Sex
Male	37 (70%)	9 (82%)	0.71	38 (72%)	9 (75%)	1.00
Female	17 (30%)	2 (18%)		15 (28%)	3 (25%)
PS
1	38 (72%)	9 (82%)	0.71	38 (72%)	10 (83%)	0.49
0	15 (28%)	2 (18%)		15 (28%)	2 (17%)
Primary tumor status
Eradicated	12 (23%)	2 (18%)	0.23	12 (23%)	2 (17%)	0.29
Eradicated but recurred locally	28 (53%)	5 (45%)		28 (53%)	6 (50%)
Residual disease	7 (13%)	1 (9%)		7 (13%)	1 (8%)
Untreated	3 (6%)	3 (27%)		3 (6%)	3 (25%)
Unknown	3 (6%)	0 (0%)		3 (6%)	0 (0%)
Smoking history
≤40 pack-years	25 (47%)	7 (64%)	0.43	25 (47%)	7 (58%)	0.61
>40 pack-years	24 (45%)	3 (27%)		24 (45%)	4 (33%)
Pipe or cigar smoker only	1 (2%)	0 (0%)		1 (2%)	0 (0%)
Unknown	3 (6%)	1 (9%)		3 (6%)	1 (8%)
Primary site
Oropharynx	12 (23%)	3 (27%)	0.024	12 (23%)	4 (33%)	0.022
Larynx	20 (38%)	0 (0%)		20 (38%)	0 (0%)
Other	21 (41%)	8 (72%)		21 (41%)	8 (66%)
Cell differentiation
Well/moderately differentiated	37 (70%)	4 (36%)	0.075	37 (70%)	5 (42%)	0.14
Poorly differentiated	10 (19%)	5 (45%)		10 (19%)	5 (42%)
Unknown	6 (11%)	2 (18%)		6 (11%)	2 (17%)
Weight loss in previous 6 months			0.55			0.80
<5%	29 (55%)	8 (73%)		29 (55%)	8 (67%)
≥5%	19 (36%)	2 (18%)		19 (36%)	3 (25%)
Unknown	5 (9%)	1 (9%)		5 (9%)	1 (8%)
Prior radiotherapy			0.024			0.033
Yes	49 (92%)	7 (64%)		49 (92%)	8 (67%)
No	4 (8%)	4 (36%)		4 (8%)	4 (33%)