Leticia Torres-Ibarra, Center for Population Health Research, National Institute of Public Health, Cuernavaca, Mexico
Attila T. Lorincz, Wolfson Institute of Preventive Medicine Centre for Cancer Prevention, Queen Mary University, London, UK
Cosette M. Wheeler, New Mexico Comprehensive Cancer Center, Center for HPV Prevention, University of New Mexico, Albuquerque, New Mexico, USA
Jack Cuzick, Wolfson Institute of Preventive Medicine Centre for Cancer Prevention, Queen Mary University, London, UK
Rubí Hernández-López, Health Plan Analysis Office, Technical Deputy Management of Health Plan, Health Plan Administration Management, General Administration, Bank of Mexico, Mexico ty, Mexico
Donna Spiegelman, Center for Methods in Implementation and Prevention Science, Yale School of Public Health, New Haven, Connecticut, USA
Leith León-Maldonado, CONACYT-Center for Population Health Research, National Institute of Public Health, Cuernavaca, Mexico
Berenice Rivera-Paredez, Faculty of Medine, Research Center on Policies, Population and Health, National Autonomous University of Mexico, Mexico City, Mexico.
Pablo Méndez-Hernández, Departamento de Calidad y Educación en Salud, Secretaria de Salud Tlaxcala, Santa Ana Chiautempan, Tlaxcala, Mexico Facultad de Ciencias de la Salud, Universidad Autónoma de Tlaxcala, Zacatelco, Tlaxcala, Mexico
Eduardo Lazcano-Ponce, School of Public Health of Mexico, National Institute of Public Health, Cuernavaca, Mexico
Jorge Salmerón, Faculty of Medine, Research Center on Policies, Population and Health, National Autonomous University of Mexico, Mexico City, Mexico

Document Type

Article

Publication Date

8-14-2020

Abstract

High-risk human papillomavirus type 16/18 (HPV16/18) genotyping is unable to accurately discriminate nonprogressive infections from those that will progress to cervical cancer. Our study aimed to assesses if additional testing either with liquid-based cytology (LBC) or the putative progression markers p16/Ki-67 and HPV16/18 E6 oncoprotein (E6) can improve the efficiency of HPV16/18 genotyping for triaging high-risk HPV (hrHPV)-positive women through better cancer risk stratification. Women attending colposcopy after positive HPV16/18 genotyping results within the Forwarding Research for Improved Detection and Access for Cervical Cancer Screening and Triage (FRIDA) hrHPV-based screening study in Tlaxcala, Mexico, underwent further testing with LBC, p16/Ki-67 dual-stained (DS) cytology and E6. We calculated measures of test performance for detecting histologically confirmed cervical intraepithelial neoplasia grade 2 or higher (CIN2+) and grade 3 or higher (CIN3+). A number of 475 (64.3%) of 739 HPV16/18-positive women had complete results for all tests. Triage positivity rates were 14.1%, 18.5% and 24.4%, for LBC, E6 and DS, respectively. Compared with LBC, DS had higher sensitivity (24.4% vs 60.0%) although lower specificity (87.0% vs 79.3%) for CIN3+ (P < .001), whereas E6 had a sensitivity of 37.8% and a specificity of 83.5%. No invasive cancer was missed by DS or E6, but 75% were in normal cytology. DS test was associated with nearly 75% reduction of colposcopy referrals compared with the direct referral of all HPV16/18-positive women, giving the least number of colposcopies (n = 4.3) per CIN3+ detected. We show that adjunctive testing of HPV16/18-positive women with DS may greatly reduce unnecessary colposcopy referrals within HPV-based screening employing HPV16/18 genotyping while retaining acceptable sensitivity for CIN2+ and CIN3+.

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