Epidemiology Characteristics and Potential Clinical Value of Vulvar Human Papillomavirus in Chinese Women: A Multicenter Cross-Sectional Study

Xiao Li; Hongyu Xie; Yunfeng Fu; Xiaofei Zhang; Xiaohui Dong; Ying Ji; Weiguo Lu; Xinyu Wang

doi:10.5858/arpa.2023-0255-OA

Epidemiology Characteristics and Potential Clinical Value of Vulvar Human Papillomavirus in Chinese Women: A Multicenter Cross-Sectional Study

Arch Pathol Lab Med. 2023 Dec 7. doi: 10.5858/arpa.2023-0255-OA. Online ahead of print.

Authors

Xiao Li^{1

2

3}, Hongyu Xie^{4

5}, Yunfeng Fu⁶, Xiaofei Zhang⁷, Xiaohui Dong¹, Ying Ji^{8

9}, Weiguo Lu^{1

2}, Xinyu Wang^{1

10}

Affiliations

¹ From the Department of Gynecologic Oncology (Li, Dong, Lu, Wang), Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.
² The Zhejiang Provincial Clinical Research Center for Obstetrics and Gynecology, Hangzhou, China (Li, Lu).
³ The Cancer Research Institute of Zhejiang University, Hangzhou, China (Li).
⁴ The Departments of the Clinical Research Center (Xie), Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.
⁵ The Zhejiang Provincial Key Laboratory of Precision Diagnosis and Therapy for Major Gynecological Diseases, Hangzhou, China (Xie).
⁶ The Centre for Diagnosis & Treatment of Cervical Diseases (Fu), Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.
⁷ The Department of Pathology (Zhang), Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.
⁸ The Shanghai Institute of Infectious Disease and Biosecurity, Fudan University, Shanghai, China (Ji).
⁹ Bovax Biotechnology Co Ltd, Shanghai, China (Ji).
¹⁰ The Department of Obstetrics and Gynecology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China (Wang).

PMID: 38059501
DOI: 10.5858/arpa.2023-0255-OA

Abstract

Context.—: Noninvasive self-sampling is a convenient option that may be highly accepted by women for home-based detection, which could increase the screening rate for cervical cancer (CC) and reduce its incidence and mortality.

Objective.—: To compare the distribution of high-risk human papillomavirus (hr-HPV) between the vulva and cervix and to explore the clinical value of vulvar HPV detection in CC screening.

Design.—: The study was nested within a clinical trial on recombinant HPV 9-valent vaccine for women ages 20 to 45 years. Women with paired vulvar and cervical specimens were included and received cytology and HPV detection. The consistency of HPV detection between vulvar and cervical specimens was evaluated using Cohen κ statistics. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were used to evaluate the diagnostic accuracy of primary CC screening. The primary end points were cervical intraepithelial neoplasia (CIN) grade 2/3 or worse (CIN2+/3+).

Results.—: A total of 7999 women were enrolled, and 83/33 cases were diagnosed as CIN2+/CIN3+. The HPV-positive rate in vulvar specimens (1785 of 7999; 22.32%) was higher than that in cervical specimens (1390 of 7999; 17.38%), and there were no significant differences in the distribution of hr-HPV genotypes between the vulva and cervix in patients with CIN2+/CIN3+. Vulva-based HPV primary screening showed sensitivity, specificity, PPV, and NPV comparable to those for cervix-based HPV primary CC screening in the detection of CIN3+.

Conclusions.—: The distribution of vulvar and cervical HPV was similar in patients with CIN2+/CIN3+. Vulva-based HPV primary CC screening had acceptable diagnostic efficacy and might be used as a modality for primary CC screening.