Table 2.
Patient characteristics.
| Total (%) | Intervention arm (%) | Control arm (%) | p-value | |
|---|---|---|---|---|
| No. of patients | 89 | 49 (55%) | 40 (45%) | |
| Sex | ||||
| Male Female |
71 (80%) 18 (20%) |
36 (73%) 13 (27%) |
35 (88%) 5 (12%) |
0.169* |
| Age at diagnosis | ||||
| Median (range) | 60.5 years (43–68) | 49 years (43–56) | 68 years (65–68) | 0.131*** |
| Baseline weight | ||||
| Median (range) | 70.5 kg (47.6–99) | 72 kg (53.3–99) | 69 kg (47.6–95) | 0.256*** |
| Baseline BMI | ||||
| Median (range) |
23.81 kg/m2
(18.01–35.76) |
23.99 kg/m2
(18.01–35.76) |
23.51 kg/m2
(18.6–35.76) |
0.204*** |
| Country | ||||
| Italy Germany Austria Poland Slovenia |
16 (18%) 28 (31%) 1 (1%) 22 (25%) 22 (25%) |
8 (16%) 15 (31%) 0 (0%) 12 (24%) 14 (29%) |
8 (20%) 13 (33%) 1 (2%) 10 (25%) 8 (20%) |
0.785** |
| Subsite | ||||
| Oral cavity Oropharynx HPV-positive HPV-negative Unknown HPV status Larynx/hypopharynx |
18 (20%) 49 (55%) 28 (57%) 18 (37%) 3 (6%) 22 (25%) |
12 (24%) 24 (49%) 11(46%) 11(46%) 2(8%) 13 (27%) |
6 (15%) 25 (63%) 17(68%) 7(28%) 1(4%) 9 (22%) |
0.395* |
| Clinical stage (TNM 7) | ||||
| III IVa/b |
29 (33%) 60 (67%) |
15 (31%) 34 (69%) |
14 (35%) 26 (65%) |
0.832* |
| Smoking exposure | ||||
| Current Previous ≥10 pack-years Never smoking/<10 pack-years |
16 (18%) 60 (67%) 13 (15%) |
7 (14%) 32 (65%) 10 (21%) |
9 (23%) 28 (70%) 3 (7%) |
0.183** |
| Previous surgery | ||||
| Yes No NA |
57 (64%) 30 (34%) 2 (2%) |
34 (69%) 15 (31%) 0 (0%) |
23 (58%) 15 (37%) 2 (5%) |
0.211** |
| Xerostomy | ||||
| Grade > 2 Grade ≤ 2 |
4 (4%) 85 (96%) |
2 (4%) 47 (96%) |
2 (5%) 38 (95%) |
1** |
Statistical tests used: *Chi-squared test, **Fisher’s exact test, and ***Mann–Whitney test.