Background: The objective of this study was to describe the determinants of adequacy and positivity of the p16/Ki-67 assay in a human papillomavirus (HPV)-positive screening population enrolled within the New Technologies for Cervical Cancer 2 (NTCC2) study. Methods: ThinPrep slides were immunostained for p16/Ki-67; each slide had 3 reports from different laboratories. The authors included population-related, sampling-related/staining-related, and interpretation-related variables in the analyses. Adequacy and positivity proportions were stratified by variables of interest. Univariate and multivariate logistic models were used to identify determinants of adequacy and positivity. Results: In total, 3100 consecutive HPV-positive cases were analyzed. Because every slide was interpreted by 3 centers, 9300 reports were obtained, including 905 (9.7%) that were inadequate and 2632 (28.3%) that were positive. The percentage of cases in which all 3 reports were inadequate increased with increasing age of the women and with inadequate cytology. The highest percentage of adequacy in all 3 reports and of cases with all 3 reports positive was observed in specimens from women who had grade ≥2 cervical intraepithelial neoplasia (CIN2+), atypical squamous cells of undetermined significance or more severe (ASC-US+) cytology, or mRNA positivity. The number of inadequate reports was significantly associated with increasing age, inadequate cytology, mRNA negativity, and scant cellularity. A positive p16/Ki-67 report was associated with an ASC-US+ result and with a positive mRNA result in cases both with and without CIN2+ but was associated with an HPV type 16 and/or 18 infection only in CIN2+ cases. The presence of CIN2+ was strongly associated with dual staining positivity. Conclusions: The interpretation of p16/Ki-67 results may be influenced by several different variables, all of which are part of the steps in the procedure, and by the characteristics of the screened population.
Determinants of p16/Ki-67 adequacy and positivity in HPV-positive women from a screening population / Benevolo, M.; Mancuso, P.; Allia, E.; Gustinucci, D.; Bulletti, S.; Cesarini, E.; Carozzi, F. M.; Confortini, M.; Bisanzi, S.; Rubino, T.; Rollo, F.; Marchi, N.; Farruggio, A.; Pusiol, T.; Venturelli, F.; Giorgi Rossi, P.; Barca, A.; Quadrino, F.; Benevolo, M.; Rollo, F.; Giorgi Rossi, P.; Bonvicini, L.; Mancuso, P.; Venturelli, F.; Carlinfante, G.; Rubino, T.; Carozzi, F. M.; Bisanzi, S.; Confortini, M.; Di Pierro, C.; Fantacci, G.; Iossa, A.; Andersson, K. L.; Mongia, A.; Pompeo, G.; Sani, C.; Puliti, D.; Baldini, A.; Ronco, G.; Rizzolo, R.; Gillio Tos, A.; De Marco, L.; Allia, E.; Pusiol, T.; Barbareschi, M.; Bragantini, E.; Passamonti, B.; Gustinucci, D.; Bulletti, S.; Cesarini, E.; Giaimo, M. D.; Penon, G.; Marchi, N.; Farruggio, A.; Bertazzo, A.; Toniolo, L.; Del Mistro, A.; Frayle, H.; Gori, S.; Zorzi, M.; Narne, E.; Turrin, A.. - In: CANCER CYTOPATHOLOGY. - ISSN 1934-662X. - 129:5(2021), pp. 383-393. [10.1002/cncy.22385]
Determinants of p16/Ki-67 adequacy and positivity in HPV-positive women from a screening population
Venturelli F.;Bonvicini L.;Venturelli F.;
2021
Abstract
Background: The objective of this study was to describe the determinants of adequacy and positivity of the p16/Ki-67 assay in a human papillomavirus (HPV)-positive screening population enrolled within the New Technologies for Cervical Cancer 2 (NTCC2) study. Methods: ThinPrep slides were immunostained for p16/Ki-67; each slide had 3 reports from different laboratories. The authors included population-related, sampling-related/staining-related, and interpretation-related variables in the analyses. Adequacy and positivity proportions were stratified by variables of interest. Univariate and multivariate logistic models were used to identify determinants of adequacy and positivity. Results: In total, 3100 consecutive HPV-positive cases were analyzed. Because every slide was interpreted by 3 centers, 9300 reports were obtained, including 905 (9.7%) that were inadequate and 2632 (28.3%) that were positive. The percentage of cases in which all 3 reports were inadequate increased with increasing age of the women and with inadequate cytology. The highest percentage of adequacy in all 3 reports and of cases with all 3 reports positive was observed in specimens from women who had grade ≥2 cervical intraepithelial neoplasia (CIN2+), atypical squamous cells of undetermined significance or more severe (ASC-US+) cytology, or mRNA positivity. The number of inadequate reports was significantly associated with increasing age, inadequate cytology, mRNA negativity, and scant cellularity. A positive p16/Ki-67 report was associated with an ASC-US+ result and with a positive mRNA result in cases both with and without CIN2+ but was associated with an HPV type 16 and/or 18 infection only in CIN2+ cases. The presence of CIN2+ was strongly associated with dual staining positivity. Conclusions: The interpretation of p16/Ki-67 results may be influenced by several different variables, all of which are part of the steps in the procedure, and by the characteristics of the screened population.
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