Table 1.

Subject characteristics by treatment group

PlaceboErlotinibErlotinib + Sulindac
(N = 12)(N = 18)(N = 16)Test of equalitya
Age
 Median596446
 Range33–8644—7349–68
Gender, N (%)
 Female3 (25)4 (22)3 (19)0.9924
 Male9 (75)14 (78)13 (81)
Tumor site
 Oral cavity8 (67)9 (50)9 (56)0.6606
 Oropharynx3 (35)5 (28)6 (38)
 Hypopharynx0 (0)2 (11)0 (0)
 Larynx1 (8)2 (11)1 (6)
Tumor (T) stageb
 11 (9)0 (0)0 (0)0.2371
 25 (45)3 (18)3 (20)
 33 (28)4 (24)5 (33)
 42 (18)10 (59)7 (47)
Nodal (N) stagec
 07 (70)8 (44)6 (40)0.3389
 11 (10)4 (22)6 (40)
 22 (20)6 (33)2 (13)
 30 (0)0 (0)1 (7)
p16 statusd
 Positive1 (11)3 (20)0 (0)0.3579
 Negative10 (89)12 (80)11 (100)
  • aWilcoxon test for age, Fisher exact two-tailed test for others.

  • bT classification was not available for three subjects.

  • cN classification was not available for three subjects.

  • dp16 status was not available for 9 patients. Among 14 oropharynx cases, 11 were p16(−), two were p16(+), and one was unknown.