Comparison of immediate colposcopy, repeat conventional cytology and high‐risk human papillomavirus testing for the clinical management of atypical squamous cells of undetermined significance cytology in routine health services of Medellin, Colombia: The ASCUS‐COL trial. Issue 6 (24th October 2020)

• Record Type: Journal Article
• Authors: Baena, Armando; Agudelo, Maria C.; Lopez, Carolina; Ramírez, Arianis Tatiana; Castañeda, Kelly Melisa; Bedoya, Astrid M.; Riveros, Marcela; Posada, Guadalupe; Borrero, Mauricio; Buitrago, Carlos A.; Suescun, David; Gomez, Luis J.; Ochoa, Juan C.; Stoler, Mark; Gage, Julia; Castle, Philip E.; Sasieni, Peter; Almonte, Maribel; Herrero, Rolando; Sanchez, Gloria I.
• Other Names: Sanchez (PI) Gloria I investigator.; Baena Armando investigator.; Agudelo Maria C investigator.; Tatiana Ramirez Arianis investigator.; Melisa Castañeda Kelly investigator.; Borrero Mauricio investigator.; Riveros Marcela investigator.; Bedoya Astrid investigator.; Botero Alejandra investigator.; Villa Catalina investigator.; Florez Victor investigator.; Lopez Carolina investigator.; Almonte Maribel investigator.; Herrero Rolando investigator.; Stoler Mark investigator.; Castle Philip E. investigator.; Sasieni Peter investigator.; Posada Guadalupe investigator.; Jaime Gomez Luis investigator.; Buitrago Carlos A. investigator.; Ochoa Juan C. investigator.; Suescun David investigator.; Cristina Rivera Claudia investigator.; Gamboa Liliana investigator.; Elena Londoño Maria investigator.; Echeverry Natalia investigator.; Elena Arboleda Ruth investigator.; Herrera Sandra investigator.; Eugenia Mejia Maria investigator.; Valencia Marleny investigator.; Toro Lina investigator.; Henry Osorio Jhon investigator.; Agudelo Jaime investigator.; Trujillo Gustavo investigator.; Jimenez Cristina investigator.; Ruiz Lizeth investigator.; Luz Arteaga Mary investigator.; Rendon Liliana investigator.; Serna Lina investigator.; Miguel Abad Jose investigator.; Eugenia Perez Beatriz investigator.; Calderon Gloria Cristina investigator.; Alexander Castañeda Jaime investigator.; Londoño Luz Helena investigator.; Sanchez Lucy investigator.;
• Is Part Of: International journal of cancer. Volume 148:Issue 6(2021)
• Page Start: 1394
• Page End: 1407
• Publication Date: 2020-10-24
• Subjects: ASC‐US cytology -- cervical cancer screening -- Colombia -- human papillomavirus implementation science; Cancer -- Periodicals; Cancer -- Prevention -- Periodicals; 616.994
• DOI: 10.1002/ijc.33318
• Languages: English
• ISSNs: 0020-7136

Abstract

Abstract: In the context of opportunistic cervical cancer screening settings of low‐and‐middle‐income countries, little is known about the benefits of high‐risk human papillomavirus (hrHPV) testing on high‐grade cervical abnormality detection among women with atypical squamous cells of undetermined significance (ASC‐US) cytology in routine clinical practice. We compared the effectiveness of immediate colposcopy (IC), conventional cytology at 6 and 12 months (colposcopy if ≥ASC‐US) (RC) and hrHPV testing (colposcopy if hrHPV‐positive) (HPV) to detect cervical intraepithelial neoplasia grade 2 or more severe diagnoses (CIN2+) among women aged 20 to 69 years with ASC‐US in routine care. Participants (n = 2661) were evenly randomized into three arms (n = 882 IC, n = 890 RC, n = 889 HPV) to receive services by routine healthcare providers and invited to an exit visit 24 months after recruitment. Histopathology was blindly reviewed by a quality‐control external panel (QC). The primary endpoint was the first QC‐diagnosed CIN2+ or CIN3+ detected during three periods: enrolment (≤6 months for IC and HPV, ≤12 months for RC), follow‐up (between enrolment and exit visit) and exit visit. The trial is completed. Colposcopy was done on 88%, 42% and 52% of participants in IC, RC and HPV. Overall, 212 CIN2+ and 52 CIN3+ cases were diagnosed. No differences were observed for CIN2+ detection ( P = .821). However, compared to IC, only HPV significantly reduced CIN3+ cases that providers were unable to detect during the 2‐year routine follow‐up (relative proportion 0.35, 95% CI 0.09‐0.87). In this context, hrHPV testing was the most effective and efficient management strategy for women with ASC‐US cytology. What's new?: Guidelines for high‐risk human papillomavirus (hrHPV) testing in cervical cancer screening were introduced in Colombia in 2014 but have yet to be adopted in clinical practice. Moreover, follow‐up for screen‐positive women, including those with atypical squamous cells of undetermined significance (ASC‐US) cytology is limited. Here, hrHPV testing for follow‐up of women with ASC‐US cytology was compared with two approaches currently available in Colombia, immediate colposcopy and repeat cytology at two‐year routine follow‐up. Compared to immediate colposcopy, hrHPV testing reduced the burden of high‐grade cervical abnormalities by 65 percent and colposcopy referral by 41 percent.