Kieran Dempster-Rivett1, Carrie R Innes2, Bryony J Simcock1, Dianne Harker2, Jonathan A Williman3, Rachael A Van Der Griend4, Martin Whitehead5, Merilyn Hibma6, Beverley A Lawton7, Peter Fitzgerald8, Narena M Dudley9, Simone Petrich10, Jim Faherty11, Cecile Bergzoll12, Lois Eva12, Lynn Sadler12, Selvan Pather13, C David Wrede14, Peter H Sykes15. 1. Department of Obstetrics and Gynaecology, University of Otago, Christchurch, New Zealand; Christchurch Women's Hospital, Christchurch, New Zealand. 2. Department of Obstetrics and Gynaecology, University of Otago, Christchurch, New Zealand. 3. Biostatistics and Computational Biology Unit, University of Otago, Christchurch. 4. Canterbury Health Laboratories, Christchurch Hospital, Christchurch, New Zealand. 5. Canterbury Health Laboratories, Christchurch Hospital, Christchurch, New Zealand; Department of Pathology, University of Otago, Christchurch, New Zealand. 6. Department of Pathology, University of Otago, Dunedin, New Zealand. 7. Women's Health Research Centre, Department of Obstetrics and Gynaecology, University of Otago, Wellington, New Zealand. 8. Southern Community Laboratories, Dunedin, New Zealand. 9. Women's Health Service, Waikato Hospital, Hamilton, New Zealand. 10. Gynaecology Services, Dunedin Hospital, Dunedin, New Zealand. 11. Obstetrics and Gynaecology Services, Southland Hospital, Invercargill, New Zealand. 12. National Women's Health, Auckland District Health Board, Auckland, New Zealand. 13. Chris O'Brien Comprehensive Cancer Centre, University of Sydney, Sydney, Australia; Department of Oncology and Dysplasia, Sydney Medical School, University of Sydney, Sydney, Australia. 14. Gynaecology Services, The Royal Women's Hospital, Melbourne, Australia; Department of Obstetrics and Gynaecology, University of Melbourne, Australia. 15. Department of Obstetrics and Gynaecology, University of Otago, Christchurch, New Zealand; Christchurch Women's Hospital, Christchurch, New Zealand. Electronic address: peter.sykes@otago.ac.nz.
Abstract
BACKGROUND: A high rate of regression in young women with cervical intraepithelial neoplasia grade 2 has been recorded. However, there are few prospective data by which to evaluate management guidelines. OBJECTIVE: This study evaluates the American Society for Colposcopy and Cervical Pathology recommendations for follow-up of young women with cervical intraepithelial neoplasia 2 using data created by a large prospective multicenter study of observational management. MATERIALS AND METHODS: Participants were 616 women under 25 years with biopsy-diagnosed cervical intraepithelial neoplasia 2 following a referral to colposcopy for an abnormal smear with no previous high-grade abnormality. The protocol included colposcopy, cytology, and colposcopically directed biopsy at the initial visit and at 6- and 12-month follow-ups visits, and these data were analyzed. Histology from the corresponding cervical biopsy was treated as the reference diagnostic test. For young women with cervical intraepithelial neoplasia 2, we aimed to determine the following: (1) the ability of colposcopy to identify women with cervical intraepithelial neoplasia 3 or worse at 6 months; and (2) the ability of colposcopy, cytology, and a combination of cytology and colposcopy to identify residual high-grade abnormalities at 12 months. In addition, although not specified in the guidelines, we investigated the ability of high-risk human papillomavirus positivity alone or with cytology as a co-test to identify residual high-grade abnormalities at 12 months. RESULTS: At 6 months, cervical intraepithelial neoplasia 3+ colposcopic appearance identified only 28% (95% confidence interval, 18-40%) of women diagnosed with cervical intraepithelial neoplasia 3. At 12 months, a high-grade colposcopic appearance identified only 58% (95% confidence interval, 48-68%) of women with residual histological cervical intraepithelial neoplasia 2 or 3. At 12 months, high-grade cytology identified only 58% (95% confidence interval, 48-68%) of women with cervical intraepithelial neoplasia 2 or 3. However, the combination of either high-grade cytology or colposcopic appearance proved substantially more sensitive (81%; 95% confidence interval, 72-88%). High-risk human papillomavirus positivity at 12 months was a sensitive (96%; 95% confidence interval, 89-99%) indicator of persisting high-grade histology. However, this sensitivity came at the expense of specificity (52%; 95% confidence interval, 45-58%). A co-test of high-risk human papillomavirus positivity or high-grade cytology at 12 months provided a high sensitivity (97%; 95% confidence interval, 90-99%) but low specificity (51%; 95% confidence interval, 45%-58%). CONCLUSION: Colposcopy and cytology are limited in their ability to exclude persistent high-grade abnormality for young women undergoing observational management for cervical intraepithelial neoplasia 2. We recommend biopsy for all women at 12 months. High-risk human papillomavirus positivity is a sensitive indicator of persistent abnormality and should be considered in those not having a biopsy.
BACKGROUND: A high rate of regression in young women with cervical intraepithelial neoplasia grade 2 has been recorded. However, there are few prospective data by which to evaluate management guidelines. OBJECTIVE: This study evaluates the American Society for Colposcopy and Cervical Pathology recommendations for follow-up of young women with cervical intraepithelial neoplasia 2 using data created by a large prospective multicenter study of observational management. MATERIALS AND METHODS:Participants were 616 women under 25 years with biopsy-diagnosed cervical intraepithelial neoplasia 2 following a referral to colposcopy for an abnormal smear with no previous high-grade abnormality. The protocol included colposcopy, cytology, and colposcopically directed biopsy at the initial visit and at 6- and 12-month follow-ups visits, and these data were analyzed. Histology from the corresponding cervical biopsy was treated as the reference diagnostic test. For young women with cervical intraepithelial neoplasia 2, we aimed to determine the following: (1) the ability of colposcopy to identify women with cervical intraepithelial neoplasia 3 or worse at 6 months; and (2) the ability of colposcopy, cytology, and a combination of cytology and colposcopy to identify residual high-grade abnormalities at 12 months. In addition, although not specified in the guidelines, we investigated the ability of high-risk human papillomavirus positivity alone or with cytology as a co-test to identify residual high-grade abnormalities at 12 months. RESULTS: At 6 months, cervical intraepithelial neoplasia 3+ colposcopic appearance identified only 28% (95% confidence interval, 18-40%) of women diagnosed with cervical intraepithelial neoplasia 3. At 12 months, a high-grade colposcopic appearance identified only 58% (95% confidence interval, 48-68%) of women with residual histological cervical intraepithelial neoplasia 2 or 3. At 12 months, high-grade cytology identified only 58% (95% confidence interval, 48-68%) of women with cervical intraepithelial neoplasia 2 or 3. However, the combination of either high-grade cytology or colposcopic appearance proved substantially more sensitive (81%; 95% confidence interval, 72-88%). High-risk human papillomavirus positivity at 12 months was a sensitive (96%; 95% confidence interval, 89-99%) indicator of persisting high-grade histology. However, this sensitivity came at the expense of specificity (52%; 95% confidence interval, 45-58%). A co-test of high-risk human papillomavirus positivity or high-grade cytology at 12 months provided a high sensitivity (97%; 95% confidence interval, 90-99%) but low specificity (51%; 95% confidence interval, 45%-58%). CONCLUSION: Colposcopy and cytology are limited in their ability to exclude persistent high-grade abnormality for young women undergoing observational management for cervical intraepithelial neoplasia 2. We recommend biopsy for all women at 12 months. High-risk human papillomavirus positivity is a sensitive indicator of persistent abnormality and should be considered in those not having a biopsy.
Authors: Mariana K Bonas; Michelle G Discacciati; Hisa M Videira; Lucas A Cavalcante; Julio C Teixeira; Diama B Vale Journal: Womens Health Rep (New Rochelle) Date: 2022-06-22
Authors: Giorgio Bogani; Luca Lalli; Francesco Sopracordevole; Andrea Ciavattini; Alessandro Ghelardi; Tommaso Simoncini; Francesco Plotti; Jvan Casarin; Maurizio Serati; Ciro Pinelli; Alice Bergamini; Barbara Gardella; Andrea Dell'Acqua; Ermelinda Monti; Paolo Vercellini; Innocenza Palaia; Giorgia Perniola; Margherita Fischetti; Giusi Santangelo; Alice Fracassi; Giovanni D'Ippolito; Lorenzo Aguzzoli; Vincenzo Dario Mandato; Luca Giannella; Cono Scaffa; Francesca Falcone; Chiara Borghi; Mario Malzoni; Andrea Giannini; Maria Giovanna Salerno; Viola Liberale; Biagio Contino; Cristina Donfrancesco; Michele Desiato; Anna Myriam Perrone; Giulia Dondi; Pierandrea De Iaco; Simone Ferrero; Giuseppe Sarpietro; Maria G Matarazzo; Antonio Cianci; Stefano Cianci; Sara Bosio; Simona Ruisi; Lavinia Mosca; Raffaele Tinelli; Rosa De Vincenzo; Gian Franco Zannoni; Gabriella Ferrandina; Marco Petrillo; Giampiero Capobianco; Salvatore Dessiole; Annunziata Carlea; Fulvio Zullo; Barbara Muschiato; Stefano Palomba; Stefano Greggi; Arsenio Spinillo; Fabio Ghezzi; Nicola Colacurci; Roberto Angioli; Pierluigi Benedetti Panici; Ludovico Muzii; Giovanni Scambia; Francesco Raspagliesi; Violante Di Donato Journal: Vaccines (Basel) Date: 2022-04-09