Objectives: the objective of this study was to identify CIN2+ patients with p16/ki67 dual-stained cytology in patients with ASCUS/LSIL cytology result. To confirm the CINtec PLUS® usefulness.
Methods: 2092 gynecology cytologies were performed between March 1st 2015 and December 31st 2015, resulting in 157 ASCUS/LSIL cytologies. Dual-stained was performed in 75 out of 157 patients. Dual- inmunostaining for p16/ki67 was performed using the CINtec PLUS® kit (Roche mtm laboratories, Mannheim, Germany). CINtec PLUS® was used on a slide processed with Thinprep 2000® (Hologic, Bedford, MA, USA) with the residual material of Preservcyt liquid cytology. In conventional cytology cases, dual-stained was realised with the HPV testing residual material. We studied 75 CINtec PLUS® cases that belong to 73 patients. Negative patients are controlled in 12 months with a new HPV test. Positive dual-staining patients were referred to colposcopy and biopsies were taken if clinically indicated. Most of the studied patients had an HPV test performed by a polymerase chain reaction in the Cobas 4800® system including 3 option results, HPV-HR +/- for 16 genotype, HPV-HR +/- for 18 genotype and HPV-HR +/- for a pool of 12 other genotypes.
Results: Patients average age was 39.85 years (SD 11.78). ASCUS/LSIL prevalence was 7.5%. 31(41.4%) out of 75 dual-stained cytologies were positive and 43(57.3%) were negative. There was one (1.3%) unsatisfactory case. Negative CINtec PLUS® cases are equal to avoid colposcopies. About dual-staining cytologies, 34 cases were LSIL and 41 ASCUS. Of the total ASCUS cases, 27(65.9%) were CINtec PLUS negative and 14(34.1) were positive. About LSIL cases, 16(47.1%) were negative and 17(50%) positive, with one case (2.9%) having unsatisfactory dual-staining. Of the 31 CINtec PLUS® positive cases there were biopsies performed in 19 cases. This biopsy results were 7 negative cases, 11 CIN1 and 2 CIN3 (one coming from ASCUS and the other one from LSIL). In the other 12 cases the biopsy wasn’t performed.
Conclusions: Dual-staining adds efficacy to the triage with cytology due to the fact that almost two thirds of the ASCUS are CINtec Plus® negative. These cases can be followed up in one year with security. Dual-staining avoid unnecessary colposcopies especially in ASCUS patients. The decrease of colposcopies avoid anxiety and inconvenience to the patient, decreases the healthcare network pressure in cervical pathology consults and decreases the screening expense. Despite of being a reduced series, this study has shown the usefulness of dual-stain in as much ASCUS as in the LSIL lesions.
1.Ikenberg H, Bergeron C, Schmidt D, et al. Screening for cervical cancer precursors with p16/Ki-67 dual-stained cytology: results of the PALMS study. J Natl Cancer Inst 2013; 105:1550–7.
2.Schmidt D, Bergeron C, Denton KJ, et al. p16/ki-67 dual-stain cytology in the triage of ASCUS and LSIL papanicolaou cytology: results from the European equivocal or mildly abnormal Papanicolaou cytology study. Cancer Cytopathol 2011;119:158–66
3.Petry KU, Schmidt D, Scherbring S, et al. Triaging Pap cytology negative, HPV positive cervical cancer screening results with p16/Ki-67 Dual-stained cytology. Gynecol Oncol 2011; 121:505–9.
4.Uijterwaal MH, Witte BI, Van Kemenade FJ, et al. Triaging borderline/mild dyskaryotic Pap cytology with p16/Ki-67 dual-stained cytology testing: cross-sectional and longitudinal outcome study. Br Journal Cancer 2014;110:1579–86