Table 4.
A comparison of worst 2-year histologic diagnosis by the clinical center pathologists by study arm and HPV risk group. CIN, cervical intraepithelial neoplasia; CIN2:≥CIN3, the ratio of CIN2 to ≥CIN3. IC, Immediate Colposcopy arm; HPV, HPV arm; CM, Conservative Management arm
| <CIN2 | CIN2 | ≥CIN3 | Total | CIN2/CIN3 | ||
|---|---|---|---|---|---|---|
| Study Arm = CM | ||||||
| HPV- | n | 491 | 11 | 0 | 502 | n/a |
| row% | 97.8% | 2.2% | 0.0% | |||
| Non-Carcinogenic | n | 210 | 10 | 7 | 227 | 1.4 |
| row% | 92.5% | 4.4% | 3.1% | |||
| Carcinogenic | n | 661 | 82 | 62 | 831 | 1.3 |
| row% | 79.5% | 9.9% | 7.5% | |||
| HPV16 | n | 157 | 53 | 94 | 304 | 0.6 |
| row% | 51.6% | 17.4% | 30.9% | |||
| Total | n | 1,519 | 156 | 163 | 1,838 | 1.0 |
| row% | 82.6% | 8.5% | 8.9% | |||
| Study Arm = HPV | ||||||
| HPV- | n | 414 | 4 | 1 | 419 | 4.0 |
| row% | 98.8% | 1.0% | 0.2% | |||
| Non-Carcinogenic | n | 167 | 16 | 2 | 185 | 8.0 |
| row% | 90.3% | 8.6% | 1.1% | |||
| Carcinogenic | n | 448 | 66 | 43 | 557 | 1.5 |
| row% | 80.4% | 11.8% | 7.7% | |||
| HPV16 | n | 115 | 50 | 55 | 220 | 0.9 |
| row% | 52.3% | 22.7% | 25.0% | |||
| Total | n | 1,144 | 136 | 101 | 1,381 | 1.3 |
| row% | 82.8% | 9.9% | 7.3% | |||
| Study Arm = IC | ||||||
| HPV- | n | 433 | 17 | 5 | 455 | 3.4 |
| row% | 95.2% | 3.7% | 1.1% | |||
| Non-Carcinogenic | n | 203 | 21 | 6 | 230 | 3.5 |
| row% | 88.3% | 9.1% | 2.6% | |||
| Carcinogenic | n | 661 | 122 | 61 | 844 | 2.0 |
| row% | 78.3% | 14.5% | 7.2% | |||
| HPV16 | n | 161 | 61 | 82 | 304 | 0.7 |
| row% | 53.0% | 20.1% | 27.0% | |||
| Total | n | 1,458 | 221 | 154 | 1,833 | 1.4 |
| row% | 79.5% | 12.1% | 8.4% | |||
*
The reason for the lower number of subjects in the HPV arm is that the HPV arm was closed prematurely for the women referred with a low-grade squamous intraepithelial Pap because of lack of utility for HPV triage in this population.