Table 2 Demographics and Treatment details of Head and Neck Cancer Study Population
Characteristics | SOC (N = 20) | Xonrid® + SOC (N = 20) | P-Value | |
|---|---|---|---|---|
Gender | Females | 4 (20.0%) | 4 (20.0%) | 1.0 |
Males | 16 (80.0%) | 16 (80.0%) | ||
Age | N | 20 | 20 | 0.6 |
Mean (SD) | 57.49 (12.34) | 55.73 (12.46) | ||
Median | 58.36 | 59.18 | ||
Range | 32.32–79.24 | 24.70–76.61 | ||
ECOG performance status | 0 | 20 (100.0%) | 20 (100.0%) | n.a. |
Concomitant medications for comorbidities | Yes | 10 (50.0%) | 9 (45.0%) | 0.7 |
No | 10 (50.0%) | 11 (55.0%) | ||
Cancer Subsite | Hypopharynx | 1 (5.0%) | 0.07 | |
Larynx | 2 (10.0%) | 2 (10.0%) | ||
Nasopharynx | 10 (50.0%) | 5 (25.0%) | ||
Oral Cavity | 4 (20.0%) | |||
Oropharynx | 4 (20.0%) | 10 (50.0%) | ||
Paranasal Sinuses | 2 (10.0%) | |||
Stage (TNM VIII Edition) | ||||
Clinical | 14 (70%) | 18 (90%) | 0.5 | |
I/II | 1 (7.2%) | 2 (11.1%) | ||
III/IV | 13 (92.8%) | 16 (88.9%) | ||
Pathological | 6 (30%) | 2 (10%) | ||
I/II | 0 | 0 | ||
III/IV | 6 (100%) | 2 (100%) | ||
Aim of radiation treatment | ||||
Definitive | 14 (70.0%) | 16 (80.0%) | 0.5 | |
Postoperative | 6 (30.0%) | 4 (20.0%) | ||
Prescribed total dose/ N° of fractions | ||||
HD-PTV Total planned dose / N° of fractions | 60.00 / 30.00 | 2 (10.0%) | 1 (5.0%) | 0.6 |
64.50 / 30.00 | 1 (5.0%) | |||
66.00 / 33.00 | 3 (15.0%) | 2 (10.0%) | ||
69.96 / 33.00 | 14 (70.0%) | 16 (80.0%) | ||
70.00 / 35.00 | 1 (5.0%) | |||
ID-PTV Total planned dose / N° of fractions | 0.00 | 7 (36.8%) | 8 (42.1%) | 0.5 |
59.40 / 33.00 | 10 (52.6%) | 1 (52.6%) | ||
60.00 / 30.00 | 1 (5.3%) | |||
66.00 / 33.00 | 1 (5.3%) | |||
LD-PTV Total planned dose / N° of fractions | 54.00 / 30.00 | 3 (15.0%) | 1 (5.0%) | 0.4 |
56.00 / 35.00 | 1 (5.0%) | |||
56.10 / 33.00 | 14 (70.0%) | 17 (85.0%) | ||
59.40 / 33.00 | 3 (15.0%) | 1 (5.0%) | ||
Baseline Erythema assessment - Skin toxicity grade | No erythema | 20 (100.0%) | 20 (100.0%) | n.a. |
SKINDEX-16 - Symptom score | N | 19 | 20 | 0.3 |
Mean (SD) | 0.00 (0.00) | 0.05 (0.22) | ||
Median | 0.00 | 0.00 | ||
Min - Max | 0.00–0.00 | 0.00–1.00 | ||
SKINDEX-16 - Emotional score | N | 19 | 20 | 0.02* |
Mean (SD) | 0.07 (0.20) | 0.79 (1.27) | ||
Median | 0.00 | 0.00 | ||
Min - Max | 0.00–0.71 | 0.00–5.14 | ||
SKINDEX-16 - Functional score | N | 19 | 20 | 0.2 |
Mean (SD) | 0.08 (0.37) | 0.56 (1.39) | ||
Median | 0.00 | 0.00 | ||
Min - Max | 0.00–1.60 | 0.00–6.00 | ||
Concomitant Chemotherapy | Yes | 16 (80.0%) | 17 (85.0%) | 0.7 |
No | 4 (20.0%) | 3 (15.0%) | ||