title: Usefulness of p16INK4astaining for managing histological high-grade squamous intraepithelial cervical lesions.
abstract: p16INK4a(p16) tumor-suppressor protein is a biomarker of human papillomavirus (HPV) oncogenic activity that has revealed a high rate of positivity in histological high-gade squamous intraepithelial lesion/cervical intraepithelial neoplasia grade 2 (HSIL/CIN2) lesions. However, there is a paucity of data regarding p16 status as a surrogate marker of HSIL/CIN2 evolution. The aim of this study was to evaluate the outcome of HSIL/CIN2 patients followed up without treatment for 12 months according to p16 immunohistochemical staining. Patients diagnosed with HSIL/CIN2 colposcopy-directed biopsy, were recruited prospectively between December 2011 and October 2013. p16 staining was performed in all HSIL/CIN2 diagnostic biopsies. Follow-up was conducted every 4 months by cytology, colposcopy and biopsy if suspicion of progression and once the 12 months of follow-up completed. Complete regression, partial regression, persistence, and progression rates of HSIL/CIN2 were defined as a final outcome. A total of 96 patients were included in the analysis. The rate of spontaneous regression was 64%, while 28% had persistent disease, and 8% progressed at 12 months of follow-up. p16 was positive in 81 (84%) initial HSIL/CIN2 biopsies. Regression was observed in all 15 p16 negative cases and in 46 of 81 (57%) p16 positive cases (P=0.001). In conclusion, patients with p16 negative HSIL/CIN2 biopsy had a high rate of regression during first 12 months of follow-up. Status of p16 staining could be considered for HSIL/CIN2 management.
authors.affiliation: Department of Obstetrics and Gynecology, Hospital del Mar, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Ester
authors.initials: E
authors.lastname: Miralpeix
authors.affiliation: Department of Obstetrics and Gynecology, Hospital del Mar, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Genovés
authors.affiliation: Department of Obstetrics and Gynecology, Hospital del Mar, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Josep
authors.initials: J
authors.lastname: Maria Solé-Sedeño
authors.affiliation: Department of Obstetrics and Gynecology, Hospital del Mar, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Gemma
authors.initials: G
authors.lastname: Mancebo
authors.affiliation: Department of Pathology, Hospital del Mar, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Belen
authors.initials: B
authors.lastname: Lloveras
authors.affiliation: Department of Pathology, Hospital del Mar, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Bellosillo
authors.affiliation: Department of Pathology, Hospital del Mar, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Francesc
authors.initials: F
authors.lastname: Alameda
authors.affiliation: Department of Obstetrics and Gynecology, Hospital del Mar, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Ramon
authors.initials: R
authors.lastname: Carreras
mesh_terms: D000293:Adolescent; D000328:Adult; D019941:Cyclin-Dependent Kinase Inhibitor p16 / Q000378:metabolism*; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007150:Immunohistochemistry; D008875:Middle Aged; D060787:Neoplasm Grading; D011446:Prospective Studies; D065310:Squamous Intraepithelial Lesions of the Cervix / Q000378:metabolism* / Q000473:pathology; D002583:Uterine Cervical Neoplasms / Q000378:metabolism* / Q000473:pathology; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000378:metabolism* / Q000473:pathology
chemical_list: D019941:Cyclin-Dependent Kinase Inhibitor p16