Table 4.
Study Arm | Baseline sample | Subsequent sample | Cancer type | Age at cancer diagnosis | |||||
---|---|---|---|---|---|---|---|---|---|
Months prior to cancer diagnosis | HPV Typea/LBC Result | S5 Score | Viral loadb | Months prior to cancer diagnosis | HPV Type(s)a/LBC Result | S5 Score | |||
CA | 67 | HPV16/NILM | 5.8 | 404.25 | Squamous large cell non‐keratinizing | 62 | |||
SA | 4 | HPV18/ASCH | 11.3 | 65.47 | Adenocarcinoma | 41 | |||
CA | 25 | NT/NILM | 5.0 | 16.31 | 1 | HPV18/ ATYENNEO | 9.4 | Adenocarcinoma | 48 |
CA | 6 | HPV18/LSIL | 1.7 | 2.20 | Adenocarcinoma | 35 | |||
CA | 40 | NT/NILM | 2.9 | 0.64 | 6 | HPV18/ASCH | 12.4 | Adenocarcinoma | 33 |
CA | 34 | NT/NILM | 5.8 | 124.91 | 5 | HPV16, HPV84/ ATYEMET | 18.5 | Adenocarcinoma | 44 |
SA | 7 | HPV16/NILM | 10.6 | 125.78 | Adenocarcinoma | 28 | |||
CA | 30 | NT/NILM | 7.3 | 0.20 | 2 | HPV18/HSIL | 27.0 | Squamous large cell non‐keratinizing | 50 |
LBC, liquid‐based cytology; CA, control arm; SA, safety arm; NT, not tested; NILM, negative for intraepithelial lesions and malignancy; ASCH, atypical squamous cells, cannot rule out high‐grade; ATYENNEO, atypical endocervical cells, favour neoplastic; LSIL, low‐grade squamous intraepithelial lesion; ATYEMET, atypical endometrial cells; HSIL, high‐grade squamous intraepithelial lesion
HPV16 and 18 were identified by the cobas 4800 HPV test; other HPV types were identified by the Linear Array HPV Genotyping test.
Hybrid capture 2 relative light unit/cutoff ratios were used as a surrogate for HPV viral load, where the threshold for a positive test was ≥1.0; higher ratios indicate a higher viral load.