Performance of standardised colposcopy to detect cervical precancer and cancer for triage of women testing positive for human papillomavirus: results from the ESTAMPA multicentric screening study
Summary: Background: Colposcopy, currently included in WHO recommendations as an option to triage human papillomavirus (HPV)-positive women, remains as the reference standard to guide both biopsy for confirmation of cervical precancer and cancer and treatment approaches. We aim to evaluate the perf...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2023-03-01
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| Series: | The Lancet Global Health |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2214109X22005459 |
| _version_ | 1828014573042532352 |
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| author | Joan Valls, PhD Armando Baena, PhD Gino Venegas, MD Marcela Celis, MD Mauricio González, MD Carlos Sosa, MD Jorge Luis Santin, MD Marina Ortega, MD Ana Soilán, MD Elmer Turcios, MD Jacqueline Figueroa, MD Margarita Rodríguez de la Peña, MD Alicia Figueredo, MD Andrea Verónica Beracochea, MD Natalia Pérez, MD Josefina Martínez-Better, MD Oscar Lora, MD Julio Yamil Jiménez, MD Diana Giménez, MD Laura Fleider, MD Yuly Salgado, BSN Sandra Martínez, BSN Yenny Bellido-Fuentes, BSN Bettsy Flores, MD Silvio Tatti, MD Verónica Villagra, MD Aurelio Cruz-Valdez, MD Carolina Terán, MD Gloria Inés Sánchez, MD Guillermo Rodríguez, MD Maria Alejandra Picconi, PhD Annabelle Ferrera, MD Laura Mendoza, ProfPhD Alejandro Calderón, MD Raul Murillo, MD Carolina Wiesner, MD Nathalie Broutet, MD Silvana Luciani, MD Carlos Pérez, MD Teresa M Darragh, ProfMD José Jerónimo, MD Rolando Herrero, MD Maribel Almonte, PhD |
| author_facet | Joan Valls, PhD Armando Baena, PhD Gino Venegas, MD Marcela Celis, MD Mauricio González, MD Carlos Sosa, MD Jorge Luis Santin, MD Marina Ortega, MD Ana Soilán, MD Elmer Turcios, MD Jacqueline Figueroa, MD Margarita Rodríguez de la Peña, MD Alicia Figueredo, MD Andrea Verónica Beracochea, MD Natalia Pérez, MD Josefina Martínez-Better, MD Oscar Lora, MD Julio Yamil Jiménez, MD Diana Giménez, MD Laura Fleider, MD Yuly Salgado, BSN Sandra Martínez, BSN Yenny Bellido-Fuentes, BSN Bettsy Flores, MD Silvio Tatti, MD Verónica Villagra, MD Aurelio Cruz-Valdez, MD Carolina Terán, MD Gloria Inés Sánchez, MD Guillermo Rodríguez, MD Maria Alejandra Picconi, PhD Annabelle Ferrera, MD Laura Mendoza, ProfPhD Alejandro Calderón, MD Raul Murillo, MD Carolina Wiesner, MD Nathalie Broutet, MD Silvana Luciani, MD Carlos Pérez, MD Teresa M Darragh, ProfMD José Jerónimo, MD Rolando Herrero, MD Maribel Almonte, PhD |
| author_sort | Joan Valls, PhD |
| collection | DOAJ |
| description | Summary: Background: Colposcopy, currently included in WHO recommendations as an option to triage human papillomavirus (HPV)-positive women, remains as the reference standard to guide both biopsy for confirmation of cervical precancer and cancer and treatment approaches. We aim to evaluate the performance of colposcopy to detect cervical precancer and cancer for triage in HPV-positive women. Methods: This cross-sectional, multicentric screening study was conducted at 12 centres (including primary and secondary care centres, hospitals, laboratories, and universities) in Latin America (Argentina, Bolivia, Colombia, Costa Rica, Honduras, Mexico, Paraguay, Peru, and Uruguay). Eligible women were aged 30–64 years, sexually active, did not have a history of cervical cancer or treatment for cervical precancer or a hysterectomy, and were not planning to move outside of the study area. Women were screened with HPV DNA testing and cytology. HPV-positive women were referred to colposcopy using a standardised protocol, including biopsy collection of observed lesions, endocervical sampling for transformation zone (TZ) type 3, and treatment as needed. Women with initial normal colposcopy or no high-grade cervical lesions on histology (less than cervical intraepithelial neoplasia [CIN] grade 2) were recalled after 18 months for another HPV test to complete disease ascertainment; HPV-positive women were referred for a second colposcopy with biopsy and treatment as needed. Diagnostic accuracy of colposcopy was assessed by considering a positive test result when the colposcopic impression at the initial colposcopy was positive minor, positive major, or suspected cancer, and was considered negative otherwise. The main study outcome was histologically confirmed CIN3+ (defined as grade 3 or worse) detected at the initial visit or 18-month visit. Findings: Between Dec 12, 2012, and Dec 3, 2021, 42 502 women were recruited, and 5985 (14·1%) tested positive for HPV. 4499 participants with complete disease ascertainment and follow-up were included in the analysis, with a median age of 40·6 years (IQR 34·7–49·9). CIN3+ was detected in 669 (14·9%) of 4499 women at the initial visit or 18-month visit (3530 [78·5%] negative or CIN1, 300 [6·7%] CIN2, 616 [13·7%] CIN3, and 53 [1·2%] cancers). Sensitivity was 91·2% (95% CI 88·9–93·2) for CIN3+, whereas specificity was 50·1% (48·5–51·8) for less than CIN2 and 47·1% (45·5–48·7) for less than CIN3. Sensitivity for CIN3+ significantly decreased in older women (93·5% [95% CI 91·3–95·3] in those aged 30–49 years vs 77·6% [68·6–85·0] in those aged 50–65 years; p<0·0001), whereas specificity for less than CIN2 significantly increased (45·7% [43·8–47·6] vs 61·8% [58·7–64·8]; p<0·0001). Sensitivity for CIN3+ was also significantly lower in women with negative cytology than in those with abnormal cytology (p<0·0001). Interpretation: Colposcopy is accurate for CIN3+ detection in HPV-positive women. These results reflect ESTAMPA efforts in an 18-month follow-up strategy to maximise disease detection with an internationally validated clinical management protocol and regular training, including quality improvement practices. We showed that colposcopy can be optimised with proper standardisation to be used as triage in HPV-positive women. Funding: WHO; Pan American Health Organization; Union for International Cancer Control; National Cancer Institute (NCI); NCI Center for Global Health; National Agency for the Promotion of Research, Technological Development, and Innovation; NCI of Argentina and Colombia; Caja Costarricense de Seguro Social; National Council for Science and Technology of Paraguay; International Agency for Research on Cancer; and all local collaborative institutions. |
| first_indexed | 2024-04-10T10:03:38Z |
| format | Article |
| id | doaj.art-5754b25fa5704f51b5238852f89df99c |
| institution | Directory Open Access Journal |
| issn | 2214-109X |
| language | English |
| last_indexed | 2024-04-10T10:03:38Z |
| publishDate | 2023-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | The Lancet Global Health |
| spelling | doaj.art-5754b25fa5704f51b5238852f89df99c2023-02-16T04:18:11ZengElsevierThe Lancet Global Health2214-109X2023-03-01113e350e360Performance of standardised colposcopy to detect cervical precancer and cancer for triage of women testing positive for human papillomavirus: results from the ESTAMPA multicentric screening studyJoan Valls, PhD0Armando Baena, PhD1Gino Venegas, MD2Marcela Celis, MD3Mauricio González, MD4Carlos Sosa, MD5Jorge Luis Santin, MD6Marina Ortega, MD7Ana Soilán, MD8Elmer Turcios, MD9Jacqueline Figueroa, MD10Margarita Rodríguez de la Peña, MD11Alicia Figueredo, MD12Andrea Verónica Beracochea, MD13Natalia Pérez, MD14Josefina Martínez-Better, MD15Oscar Lora, MD16Julio Yamil Jiménez, MD17Diana Giménez, MD18Laura Fleider, MD19Yuly Salgado, BSN20Sandra Martínez, BSN21Yenny Bellido-Fuentes, BSN22Bettsy Flores, MD23Silvio Tatti, MD24Verónica Villagra, MD25Aurelio Cruz-Valdez, MD26Carolina Terán, MD27Gloria Inés Sánchez, MD28Guillermo Rodríguez, MD29Maria Alejandra Picconi, PhD30Annabelle Ferrera, MD31Laura Mendoza, ProfPhD32Alejandro Calderón, MD33Raul Murillo, MD34Carolina Wiesner, MD35Nathalie Broutet, MD36Silvana Luciani, MD37Carlos Pérez, MD38Teresa M Darragh, ProfMD39José Jerónimo, MD40Rolando Herrero, MD41Maribel Almonte, PhD42Early Detection, Prevention and Infections Branch, International Agency for Research on Cancer, Lyon, France; Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Madrid, Spain; Correspondence to: Dr Joan Valls, Early Detection, Prevention and Infections Branch, International Agency for Research on Cancer, Lyon 69366, FranceEarly Detection, Prevention and Infections Branch, International Agency for Research on Cancer, Lyon, FranceClínica Angloamericana, Lima, Peru; Escuela de Medicina Humana, Universidad de Piura, Lima, PeruInstituto Nacional de Cancerología, Bogotá, ColombiaInstituto Nacional de Cancerología, Bogotá, ColombiaHospital Monseñor Victor Manuel Sanabria Martínez, Puntarenas, Costa RicaHospital Monseñor Victor Manuel Sanabria Martínez, Puntarenas, Costa RicaHospital Nacional, Ministerio de Salud Pública y Bienestar Social, Itauguá, Paraguay; Instituto Nacional del Cáncer, Ministerio de Salud Pública y Bienestar Social, Capiatá, ParaguayHospital Nacional, Ministerio de Salud Pública y Bienestar Social, Itauguá, Paraguay; Hospital Materno Infantil de San Lorenzo, Ministerio de Salud Pública y Bienestar Social, San Lorenzo, ParaguayPrograma Nacional contra el Cáncer, Tegucigalpa, HondurasPrograma Nacional contra el Cáncer, Tegucigalpa, HondurasHospital Nacional Profesor Alejandro Posadas, Buenos Aires, ArgentinaHospital Nacional Profesor Alejandro Posadas, Buenos Aires, ArgentinaCentro de Salud Ciudad de la Costa, Ciudad de la Costa, Uruguay; Hospital Policial, Montevideo, UruguayHospital de Clínicas, Facultad de Medicina, Montevideo, UruguayEse Hospital Antonio Roldán Betancur, Apartadó, ColombiaFacultad de Medicina, Universidad Mayor, Real y Pontificia de San Francisco Xavier de Chuquisaca, Sucre, Bolivia; Hospital Gineco-Obstétrico y Neonatal Dr Jaime Sánchez Porcel, Sucre, BoliviaInstituto de Salud Pública de Mexico, Morelos, MexicoHospital Materno Infantil de Trinidad, Ministerio de Salud Pública y Bienestar Social, Asunción, ParaguayHospital de Clínicas, José de San Martín, Buenos Aires, ArgentinaInstituto Nacional de Cancerología, Bogotá, ColombiaInstituto Nacional de Cancerología, Bogotá, ColombiaLiga contra el Cáncer-Peru, Lima, PeruFacultad de Medicina, Universidad Mayor, Real y Pontificia de San Francisco Xavier de Chuquisaca, Sucre, BoliviaHospital de Clínicas, José de San Martín, Buenos Aires, ArgentinaLaboratorio Central de Salud Pública, Asunción, ParaguayInstituto de Salud Pública de Mexico, Morelos, MexicoFacultad de Medicina, Universidad Mayor, Real y Pontificia de San Francisco Xavier de Chuquisaca, Sucre, BoliviaGrupo de Infección y Cáncer, Universidad de Antioquía, Medellín, ColombiaComisión Honoraria de Lucha contra el Cáncer, Montevideo, UruguayInstituto Nacional de Enfermedades Infecciosas—ANLIS Malbrán, Buenos Aires, ArgentinaInstituto de Infecciones en Microbiología, Universidad Nacional Autónoma de Honduras, Tegucigalpa, HondurasInstituto de Investigaciones en Ciencias de la Salud, Universidad Nacional de Asunción, San Lorenzo, ParaguayCaja Costarricense de Seguro Social, Región Pacífico Central, San José, Costa RicaEarly Detection, Prevention and Infections Branch, International Agency for Research on Cancer, Lyon, France; Instituto Nacional de Cancerología, Bogotá, ColombiaInstituto Nacional de Cancerología, Bogotá, ColombiaDepartment of Sexual and Reproductive Health and Research, WHO, Geneva, SwitzerlandPan American Health Organization, Washington, DC, USAInstituto Nacional de Cancerología, Bogotá, ColombiaDepartment of Pathology, University of California, San Francisco, CA, USALiga contra el Cáncer-Peru, Lima, Peru; US National Cancer Institute, Bethesda, MD, USAEarly Detection, Prevention and Infections Branch, International Agency for Research on Cancer, Lyon, France; Agencia Costarricense de Investigaciones Biomédicas, Fundación Inciensa, Guanacaste, Costa RicaEarly Detection, Prevention and Infections Branch, International Agency for Research on Cancer, Lyon, France; Department of Sexual and Reproductive Health and Research, WHO, Geneva, SwitzerlandSummary: Background: Colposcopy, currently included in WHO recommendations as an option to triage human papillomavirus (HPV)-positive women, remains as the reference standard to guide both biopsy for confirmation of cervical precancer and cancer and treatment approaches. We aim to evaluate the performance of colposcopy to detect cervical precancer and cancer for triage in HPV-positive women. Methods: This cross-sectional, multicentric screening study was conducted at 12 centres (including primary and secondary care centres, hospitals, laboratories, and universities) in Latin America (Argentina, Bolivia, Colombia, Costa Rica, Honduras, Mexico, Paraguay, Peru, and Uruguay). Eligible women were aged 30–64 years, sexually active, did not have a history of cervical cancer or treatment for cervical precancer or a hysterectomy, and were not planning to move outside of the study area. Women were screened with HPV DNA testing and cytology. HPV-positive women were referred to colposcopy using a standardised protocol, including biopsy collection of observed lesions, endocervical sampling for transformation zone (TZ) type 3, and treatment as needed. Women with initial normal colposcopy or no high-grade cervical lesions on histology (less than cervical intraepithelial neoplasia [CIN] grade 2) were recalled after 18 months for another HPV test to complete disease ascertainment; HPV-positive women were referred for a second colposcopy with biopsy and treatment as needed. Diagnostic accuracy of colposcopy was assessed by considering a positive test result when the colposcopic impression at the initial colposcopy was positive minor, positive major, or suspected cancer, and was considered negative otherwise. The main study outcome was histologically confirmed CIN3+ (defined as grade 3 or worse) detected at the initial visit or 18-month visit. Findings: Between Dec 12, 2012, and Dec 3, 2021, 42 502 women were recruited, and 5985 (14·1%) tested positive for HPV. 4499 participants with complete disease ascertainment and follow-up were included in the analysis, with a median age of 40·6 years (IQR 34·7–49·9). CIN3+ was detected in 669 (14·9%) of 4499 women at the initial visit or 18-month visit (3530 [78·5%] negative or CIN1, 300 [6·7%] CIN2, 616 [13·7%] CIN3, and 53 [1·2%] cancers). Sensitivity was 91·2% (95% CI 88·9–93·2) for CIN3+, whereas specificity was 50·1% (48·5–51·8) for less than CIN2 and 47·1% (45·5–48·7) for less than CIN3. Sensitivity for CIN3+ significantly decreased in older women (93·5% [95% CI 91·3–95·3] in those aged 30–49 years vs 77·6% [68·6–85·0] in those aged 50–65 years; p<0·0001), whereas specificity for less than CIN2 significantly increased (45·7% [43·8–47·6] vs 61·8% [58·7–64·8]; p<0·0001). Sensitivity for CIN3+ was also significantly lower in women with negative cytology than in those with abnormal cytology (p<0·0001). Interpretation: Colposcopy is accurate for CIN3+ detection in HPV-positive women. These results reflect ESTAMPA efforts in an 18-month follow-up strategy to maximise disease detection with an internationally validated clinical management protocol and regular training, including quality improvement practices. We showed that colposcopy can be optimised with proper standardisation to be used as triage in HPV-positive women. Funding: WHO; Pan American Health Organization; Union for International Cancer Control; National Cancer Institute (NCI); NCI Center for Global Health; National Agency for the Promotion of Research, Technological Development, and Innovation; NCI of Argentina and Colombia; Caja Costarricense de Seguro Social; National Council for Science and Technology of Paraguay; International Agency for Research on Cancer; and all local collaborative institutions.http://www.sciencedirect.com/science/article/pii/S2214109X22005459 |
| spellingShingle | Joan Valls, PhD Armando Baena, PhD Gino Venegas, MD Marcela Celis, MD Mauricio González, MD Carlos Sosa, MD Jorge Luis Santin, MD Marina Ortega, MD Ana Soilán, MD Elmer Turcios, MD Jacqueline Figueroa, MD Margarita Rodríguez de la Peña, MD Alicia Figueredo, MD Andrea Verónica Beracochea, MD Natalia Pérez, MD Josefina Martínez-Better, MD Oscar Lora, MD Julio Yamil Jiménez, MD Diana Giménez, MD Laura Fleider, MD Yuly Salgado, BSN Sandra Martínez, BSN Yenny Bellido-Fuentes, BSN Bettsy Flores, MD Silvio Tatti, MD Verónica Villagra, MD Aurelio Cruz-Valdez, MD Carolina Terán, MD Gloria Inés Sánchez, MD Guillermo Rodríguez, MD Maria Alejandra Picconi, PhD Annabelle Ferrera, MD Laura Mendoza, ProfPhD Alejandro Calderón, MD Raul Murillo, MD Carolina Wiesner, MD Nathalie Broutet, MD Silvana Luciani, MD Carlos Pérez, MD Teresa M Darragh, ProfMD José Jerónimo, MD Rolando Herrero, MD Maribel Almonte, PhD Performance of standardised colposcopy to detect cervical precancer and cancer for triage of women testing positive for human papillomavirus: results from the ESTAMPA multicentric screening study The Lancet Global Health |
| title | Performance of standardised colposcopy to detect cervical precancer and cancer for triage of women testing positive for human papillomavirus: results from the ESTAMPA multicentric screening study |
| title_full | Performance of standardised colposcopy to detect cervical precancer and cancer for triage of women testing positive for human papillomavirus: results from the ESTAMPA multicentric screening study |
| title_fullStr | Performance of standardised colposcopy to detect cervical precancer and cancer for triage of women testing positive for human papillomavirus: results from the ESTAMPA multicentric screening study |
| title_full_unstemmed | Performance of standardised colposcopy to detect cervical precancer and cancer for triage of women testing positive for human papillomavirus: results from the ESTAMPA multicentric screening study |
| title_short | Performance of standardised colposcopy to detect cervical precancer and cancer for triage of women testing positive for human papillomavirus: results from the ESTAMPA multicentric screening study |
| title_sort | performance of standardised colposcopy to detect cervical precancer and cancer for triage of women testing positive for human papillomavirus results from the estampa multicentric screening study |
| url | http://www.sciencedirect.com/science/article/pii/S2214109X22005459 |
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