A positive HPV test with positive p16/Ki-67 double staining in self-sampled vaginal material is an accurate tool to detect women at risk for cervical cancer

Author(s):Show less -

Lorenzi, Noely P. C. ^{[1, 2]} ; Termini, Lara ^[3] ; Ferreira-Filho, Edson S. ^{[1, 4]} ; Nunes, Rafaella A. L. ^[3] ; Silva, Gabriela A. F. ^[3] ; Lepique, Ana P. ^[5] ; Longatto-Filho, Adhemar ^{[6, 7, 8, 9, 10]} ; Tacla, Maricy ^[4] ; Baracat, Edmund C. ^{[1, 4]} ; Villa, Luisa L. ^{[11, 3]} ; Soares-Junior, Jose M. ^{[1, 4]}

Affiliation:Show less -

^[1] Univ Sao Paulo, Fac Med, Dept Obstet & Ginecol, Disciplina Ginecol, Sao Paulo - Brazil

^[2] Univ Sao Paulo, Hosp Univ, Dept Ginecol, Sao Paulo - Brazil

^[3] Univ Sao Paulo, Hosp Clin, Fac Med, Inst Canc Estado Sao Paulo, Ctr Translat Invest On, Sao Paulo - Brazil

^[4] Univ Sao Paulo, Hosp Clin, Fac Med, Div Clin Ginecol, Sao Paulo - Brazil

^[5] Univ Sao Paulo, Inst Ciencias Biomed, Sao Paulo - Brazil

^[6] Univ Sao Paulo, Fac Med, Dept Pathol, Sao Paulo - Brazil

^[7] Barretos Canc Hosp Pio XII Fdn, Mol Oncol Res Ctr, Sao Paulo - Brazil

^[8] Univ Sao Paulo, Fac Med, Med Lab Med Invest 14, Sao Paulo - Brazil

^[9] Univ Minho, Res Inst Life & Hlth Sci, Braga - Portugal

^[10] 8ICVS 3Bs Associated Lab Govt Portugal, Braga - Portugal

^[11] Univ Sao Paulo, Fac Med, Dept Radiol & Oncol, Sao Paulo - Brazil

• Document type: Journal article
• Source: CANCER CYTOPATHOLOGY; AUG 2021.
• Web of Science Citations: 0

Abstract

BACKGROUND: The development of efficient strategies for managing high-risk human papillomavirus (HR-HPV)-positive women is a major challenge when human papillomavirus-based primary screening is being performed. The objectives of this study were to evaluate the comparative effectiveness of HR-HPV testing based on self-collection (SC) and HR-HPV testing based on collection by a health professional (HP) and to assess the potential usefulness of HR-HPV testing combined with testing with the biomarkers p16/Ki-67, alpha-mannosidase, and superoxide dismutase 2 (SOD2). METHODS: This was a cross-sectional study of 232 women admitted for colposcopy because of an abnormal Papanicolaou smear. The collected material underwent liquid-based cytology, HR-HPV detection, and immunocytochemical testing (p16/Ki-67, alpha-mannosidase, and SOD2). The gold standard was the histopathological result; the positive reference was CIN2+. RESULTS: The overall accuracy of HR-HPV testing was 76.6%; the results for the SC group (78.1%) and the HP group (75.2%) were similar. The positive predictive values (HP, 76.5%; SC, 80.0%), the negative predictive values (HP, 66.7%; SC, 64.3%), the positive likelihood values (HP, 1.35; SC, 1.36), and the negative likelihood values (HP, 0.21; SC, 0.19) were also similar. p16/Ki-67 showed higher sensitivity than the other 2 biomarkers: 78.1% versus 45.8% for alpha-mannosidase and 44.5% for SOD2. The specificities of the biomarkers were equivalent: 71.4% for p16/Ki-67, 77.8% for alpha-mannosidase, and 71.2% for SOD2. In the HP group, accuracy also leaned more heavily toward the final score (using alpha-mannosidase and SOD2) without statistical significance (80.8% vs 77.9%). The contrast with the SC group yielded the same level of accuracy. CONCLUSIONS: SC, when associated with testing with biomarkers, is as accurate as collection by HPs in the detection of women at risk for cervical cancer. (AU)

• FAPESP's process: 16/16847-0 - Effectiveness of cervicovaginal self sampling in screening of cervical cancer
• Grantee: José Maria Soares Junior
• Support type: Regular Research Grants
• FAPESP's process: 15/26327-1 - Study of superoxide dismutase-2 protein in HPV-mediated cell transformation
• Grantee: Gabriela Ávila Fernandes Silva
• Support type: Scholarships in Brazil - Master
• FAPESP's process: 15/26573-2 - STUDY OF SUPEROXIDE DISMUTASE-2 PROTEIN IN HPV-MEDIATED CELL TRANSFORMATION
• Grantee: Lara Termini
• Support type: Regular Research Grants
• FAPESP's process: 08/57889-1 - Institute of Science and Technology to study Diseases Associated with Papillomavirus
• Grantee: Luisa Lina Villa
• Support type: Research Projects - Thematic Grants