Table 1 Demographics and Treatment details of Breast Cancer Study Population
Characteristics | SOC (N = 20) | Xonrid® + SOC (N = 20) | p-Value | |
|---|---|---|---|---|
Gender | Females | 20 (100.0%) | 20 (100.0%) | n.a. |
Age | N | 20 | 20 | 0.7 |
Mean (SD) | 49.01 (4.54) | 49.56 (4.80) | ||
Median | 48.99 | 49.03 | ||
Range | 38.26–57.75 | 40.38–57.94 | ||
ECOG performance status | 0 | 20 (100.0%) | 20 (100.0%) | n.a. |
Concomitant medications for comorbidities | Yes | 12 (60.0%) | 9 (45.0%) | 0.3 |
No | 8 (40.0%) | 11 (55.0%) | ||
Histology | DCIS | 2 (10.0%) | 3 (15.0%) | 0.4 |
Invasive Ductal Carcinoma | 18 (90.0%) | 17 (85%) | ||
Stage TNM VIII Edition | DCIS | 2 (10.0%) | 3 (15.0%) | 0.5 |
IA | 11 (55.0%) | 16 (80.0%) | ||
IB | 1 (5%) | 1 (5%) | ||
II A | 3 (15%) | |||
IIB | 3 (15%) | |||
Prescribed total dose/ N° of fractions | 50 / 25 | 2 (10.0%) | 3 (15.0%) | 0.6 |
60 / 30 | 18 (90.0%) | 17 (85.0%) | ||
Baseline Erythema assessment - Skin toxicity grade | No erythema | 20 (100.0%) | 20 (100.0%) | 0.3 |
SKINDEX-16 - Symptom score | N | 20 | 20 | 0.3 |
Mean (SD) | 0.06 (0.23) | 0.16 (0.40) | ||
Median | 0.00 | 0.00 | ||
Min - Max | 0.00–1.00 | 0.00–1.50 | ||
SKINDEX-16 - Emotional score | N | 20 | 20 | 0.9 |
Mean (SD) | 0.19 (0.46) | 0.16 (0.31) | ||
Median | 0.00 | 0.00 | ||
Min - Max | 0.00–1.71 | 0.00–1.00 | ||
SKINDEX-16 - Functional score | N | 20 | 20 | 0.6 |
Mean (SD) | 0.08 (0.28) | 0.16 (0.54) | ||
Median | 0.00 | 0.00 | ||
Min - Max | 0.00–1.20 | 0.00–2.40 | ||