Table 2. Risk of Keratinocyte Carcinoma in Year 1 and Time to Outcome During Overall Study Perioda.
| Type of Lesion | Fluorouracil Group: Participants With ≥1 Lesion, No. (%) | Control Group: Participants With ≥1 Lesion, No. (%) | Hazard Ratio (95% CI) | Risk Ratio (95% CI) | P Value of Risk Ratio |
|---|---|---|---|---|---|
| Year 1 | |||||
| KC | 48 of 468 (10) | 63 of 464 (14) | 0.74 (0.51-1.08) |
0.76 (0.53-1.08) |
.12 |
| BCC | 45 of 468 (10) | 50 of 464 (11) | 0.89 (0.59-1.33) |
0.89 (0.61-1.31) |
.56 |
| SCC | 5 of 468 (1) | 20 of 464 (4) | 0.24 (0.09-0.65) |
0.25 (0.09-0.65) |
.002 |
| Overall Study Period | |||||
| KC | 182 of 468 (39) | 177 of 464 (38) | 1.01 (0.83-1.25) |
1.02 (0.87-1.20) |
.82 |
| BCC | 151 of 468 (32) | 148 of 464 (32) | 1.02 (0.81-1.28) |
1.01 (0.84-1.22) |
.85 |
| SCC | 52 of 468 (11) | 56 of 464 (12) | 0.90 (0.62-1.31) |
0.92 (0.65-1.31) |
.65 |
Abbreviations: BCC, basal cell carcinoma; KC, keratinocyte carcinoma (ie, BCC or SCC); SCC, squamous cell carcinoma.
a
The median follow-up was 2.8 years (mean, 2.7 years) for both groups. In the fluorouracil group, 317 KCs (246 BCCs and 71 SCCs) were treated surgically during the overall study; 62 of these (57 BCCs and 5 SCCs) in year 1. In the control group, 330 KCs (251 BCCs and 79 SCCs) were treated surgically during the overall study; 91 of these (68 BCCs and 23 SCCs) in year 1.