Table 4.
Risk of anal intraepithelial neoplasia grade 2 and anal intraepithelial neoplasia grade 3 according to combinations of mRNA, p16/Ki-67, and HPV16/18 DNA.
| Test combination | No dysplasia | AIN1 | AIN2 | AIN3 | Total |
|---|---|---|---|---|---|
| mRNA+/p16/Ki-67+/16/18+ | 12 (12.50%) | 25 (26.04%) | 25 (26.04%) | 34 (35.42%) | 96 |
| mRNA+/p16/Ki-67+/16/18− | 16 (33.33%) | 11 (22.92%) | 11 (22.92%) | 10 (20.83%) | 48 |
| mRNA+/p16/Ki-67−/16/18+ | 3 (33.33%) | 5 (55.56%) | 0 (0%) | 1 (11.11%) | 9 |
| mRNA+/p16/Ki-67−/16/18− | 5 (50.0%) | 3 (30.0%) | 1 (10.0%) | 1 (10.0%) | 10 |
| mRNA−/p16/Ki-67+/16/18+ | 2 (28.57%) | 2 (28.57%) | 2 (28.57%) | 1 (14.29%) | 7 |
| mRNA−/p16/Ki-67+/16/18− | 26 (40.63%) | 25 (39.06%) | 5 (7.81%) | 8 (12.50%) | 64 |
| mRNA−/p16/Ki-67−/16/18+ | 2 (25.0%) | 4 (50%) | 1 (12.50%) | 1 (12.50%) | 8 |
| mRNA−/p16/Ki-67−/16/18− | 61 (81.33%) | 11 (14.67%) | 2 (2.67%) | 1 (1.33%) | 75 |
Combined disease endpoints: no dysplasia, including men with a nondysplastic biopsy or without a biopsy and with <HSIL cytology; AIN1, including men with AIN1 histology and <HSIL cytology; AIN2, including men with AIN2 histology or with lower grade, normal, or no histology and with HSIL-AIN2; AIN3, including men with AIN3 histology or with lower grade, normal, or no histology and with HSIL-AIN3. AIN1, anal intraepithelial neoplasia grade 1; AIN2, anal intraepithelial neoplasia grade 2; AIN3, anal intraepithelial neoplasia grade 3; HPV, human papillomavirus; HSIL, high-grade squamous intraepithelial lesion.