HPV genotyping for triage of women with abnormal cervical cancer screening results: a multicenter prospective study

• Published in: International journal of clinical oncology Vol. 20; no. 5; pp. 974 - 981
• Main Authors: Nakamura, Yuko, Matsumoto, Koji, Satoh, Toyomi, Nishide, Ken, Nozue, Akiko, Shimabukuro, Koji, Endo, Seiichi, Nagai, Kimihiro, Oki, Akinori, Ochi, Hiroyuki, Morishita, Yukio, Noguchi, Masayuki, Yoshikawa, Hiroyuki
• Format: Journal Article
• Language: English
• Published: Tokyo Springer Japan 01.10.2015; Springer Nature B.V
• Subjects: Adult; Atypical Squamous Cells of the Cervix - pathology; Cancer Research; Cervical cancer; Colposcopy; Cytodiagnosis; Early Detection of Cancer; Female; Genotype; Genotype & phenotype; Human papillomavirus; Human papillomavirus 16; Humans; Medicine; Medicine & Public Health; Middle Aged; Oncology; Original Article; Papanicolaou Test; Papillomaviridae - genetics; Prospective Studies; Squamous Intraepithelial Lesions of the Cervix - pathology; Squamous Intraepithelial Lesions of the Cervix - virology; Studies; Surgical Oncology; Triage; Uterine Cervical Neoplasms - pathology; Uterine Cervical Neoplasms - virology; Vaginal Smears; Low-grade squamous intraepithelial lesion; Human papillomavirus; Colposcopy; Genotyping; Cervical intraepithelial neoplasia; Cervical cancer
• ISSN: 1341-9625; 1437-7772
• DOI: 10.1007/s10147-015-0789-4

Background In cervical cancer screening programs, women with abnormal cytology are referred for colposcopy for histological evaluation. We examined whether a human papillomavirus (HPV) genotyping assay could be used to identify women who do not need immediate colposcopy and biopsy because of low risk of cervical intraepithelial neoplasia grade 3 or worse (CIN3+). Methods We prospectively evaluated test performance for 2 carcinogenic HPV genotypes (HPV16/18), for 8 types (HPV16/18/31/33/35/45/52/58), and for 13 types (HPV16/18/31/33/35/45/51/52/56/58/59/68) for prediction of histological CIN3+ results among 427 screen-positive women referred for colposcopy. The study subjects consisted of 214 women with low-grade squamous intraepithelial lesion (LSIL), 184 with high-grade squamous intraepithelial lesion (HSIL), and 29 with atypical squamous cells, cannot exclude HSIL (ASC-H). Results Among women with LSIL cytology, HPV16/18 positivity was 29.4 % and increased to 58.9 % for 8 types and to 74.8 % for 13 types ( P  < 0.001). The risk of CIN3+ biopsy results was still 7.9 % for women testing negative for HPV16/18, but decreased to 0.0 % for those testing negative for at least eight types of HPV (HPV16/18/31/33/35/45/52/58). Although HPV genotyping results enabled additional risk stratification among women with HSIL/ASC-H cytology, the risk of histological CIN3+ diagnosis among women testing negative for eight types or more was still sufficiently high (>35 %) to warrant immediate colposcopy referral. Conclusions Of women with LSIL cytology, those testing negative for at least eight of the highest-risk types of HPV (HPV16/18/31/33/35/45/52/58) may not need immediate colposcopy and biopsy. This would reduce the number of colposcopy referrals by approximately 40 %. However, the HPV genotyping assay is not likely to alter the clinical management of women with HSIL/ASC-H.