TABLE 1.
Randomized Subject Baseline Characteristics
| DFMO | Placebo | ||
|---|---|---|---|
| Number of patients | 144 | 147 | |
| Age (years) | 61.6 | 60.2 | |
| Gender | |||
| Female (%) | 39.6 | 40.1 | |
| Male (%) | 60.4 | 59.9 | |
| Race | |||
| White (%) | 100 | 100 | |
| Performance status (ECOG) | |||
| Zero (%) | 92.4 | 91.2 | |
| One (%) | 7.6 | 8.2 | |
| Body Surface Area (m2) | 1.94 ±0.24 | 1.99 ±0.23 | |
| Baseline Concomitant Medications | |||
| Sunscreen (%) | 79.9 | 82.3 | |
| Vitamin A (%) | 6.9 | 6.1 | |
| Vitamin C (%) | 38.9 | 31.3 | |
| Vitamin E (%) | 45.1 | 42.2 | |
| NSAIDS (%) | 52.8 | 53.1 | |
| Prior Non-melanoma Skin Cancers | 4.2 ±7.7 | 4.9 ±5.7 | p=0.10 |
| Time Since First Diagnosis of Skin Cancer | p=0.002 | ||
| 0–6 months (%) | 23.6 | 11.6 | |
| 7–12 months (%) | 9.7 | 9.5 | |
| 13–18 months (%) | 7.6 | 4.1 | |
| 19–24 months (%) | 7.6 | 6.1 | |
| >24 months (%) | 51.4 | 68.7 | |
| Prior Tumor Rate (NMSC/year) | 2.3 ±3.3 | 2.1 ±3.5 | p=0.08 |
Mean values with and without Standard Deviation, p-values were calculated with chi-square tests for dichotomous data, and Wilcoxon rank-sum test for ordinal data. Prior tumor rate is defined as the number of prior skin cancers divided by the time from the initial diagnosis to randomization.