Postcolposcopy Management of Women With Histologically Proven CIN 1

Results From TOMBOLA

Mahalakshmi Gurumurthy*, Seonaidh C. Cotton, Linda Sharp, Louise Smart, Julian Little, Norman Waugh, Margaret E. Cruickshank

*Corresponding author for this work

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Objectives. This study aimed to determine during 36 months of follow-up the (1) clinical outcomes and (2) influence of high-risk human papillomavirus (HPV) status on the risk of progression to cervical intraepithelial neoplasia 2+ (CIN 2+), amongwomen with histologically proven CIN 1.

Materials and Methods. This is an ad hoc analysis of women with CIN 1 within TOMBOLA, a randomized trial of the management of women with low-grade cervical cytology. Women from the colposcopy arm with CIN 1 confirmed on punch biopsies and managed conservatively by cytology every 6 months in primary care were included. Sociodemographic data and a sample for HPV testing were collected at recruitment. Data on the sample women were extracted to calculate the cumulative incidence of CIN 2+ and the performance characteristics of the baseline HPV test. Detection of CIN 2 or worse (CIN 2+) during follow-up or at exit colposcopy was analyzed.

Results. A total of 171 women were included. Their median age was 29 years. Fifty-two percent were high-risk HPV positive, 17% were HPV-16 positive, and 11% were HPV-18 positive. Overall, 21 women (12%) developed CIN 2+, with a median time to detection of 25 months. Factors associated with progression to CIN 2+ were presence of HPV-18 (relative risk = 3.04; 95% CI = 1.09Y8.44) and HPV-16 and/or HPV-18 at recruitment (relative risk = 3.98; 95% CI = 1.60Y9.90). The sensitivity and specificity of a combined HPV-16/HPV-18 test for the detection of CIN 2+ during 3 years were 58% and 78%, respectively.

Conclusions. Our results suggest that women with confirmed CIN 1 have low rates of progression to high-grade CIN within 3 years. Because the median time to progression was 25 months, conservative management could recommend the next repeat cytology at 2 years.

Original languageEnglish
Pages (from-to)203-209
Number of pages7
JournalJournal of Lower Genital Tract Disease
Volume18
Issue number3
DOIs
Publication statusPublished - Jul 2014

Keywords

  • cervical intraepithelial neoplasia
  • CIN
  • low-grade abnormalities
  • colposcopy
  • human papillomavirus (HPV)
  • RISK
  • abnormalities
  • borderline
  • strategies
  • cytology
  • grade-3
  • lesions
  • trial

Cite this

Postcolposcopy Management of Women With Histologically Proven CIN 1 : Results From TOMBOLA. / Gurumurthy, Mahalakshmi; Cotton, Seonaidh C.; Sharp, Linda; Smart, Louise; Little, Julian; Waugh, Norman; Cruickshank, Margaret E.

In: Journal of Lower Genital Tract Disease, Vol. 18, No. 3, 07.2014, p. 203-209.

Research output: Contribution to journalArticle

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title = "Postcolposcopy Management of Women With Histologically Proven CIN 1: Results From TOMBOLA",
abstract = "Objectives. This study aimed to determine during 36 months of follow-up the (1) clinical outcomes and (2) influence of high-risk human papillomavirus (HPV) status on the risk of progression to cervical intraepithelial neoplasia 2+ (CIN 2+), amongwomen with histologically proven CIN 1.Materials and Methods. This is an ad hoc analysis of women with CIN 1 within TOMBOLA, a randomized trial of the management of women with low-grade cervical cytology. Women from the colposcopy arm with CIN 1 confirmed on punch biopsies and managed conservatively by cytology every 6 months in primary care were included. Sociodemographic data and a sample for HPV testing were collected at recruitment. Data on the sample women were extracted to calculate the cumulative incidence of CIN 2+ and the performance characteristics of the baseline HPV test. Detection of CIN 2 or worse (CIN 2+) during follow-up or at exit colposcopy was analyzed.Results. A total of 171 women were included. Their median age was 29 years. Fifty-two percent were high-risk HPV positive, 17{\%} were HPV-16 positive, and 11{\%} were HPV-18 positive. Overall, 21 women (12{\%}) developed CIN 2+, with a median time to detection of 25 months. Factors associated with progression to CIN 2+ were presence of HPV-18 (relative risk = 3.04; 95{\%} CI = 1.09Y8.44) and HPV-16 and/or HPV-18 at recruitment (relative risk = 3.98; 95{\%} CI = 1.60Y9.90). The sensitivity and specificity of a combined HPV-16/HPV-18 test for the detection of CIN 2+ during 3 years were 58{\%} and 78{\%}, respectively.Conclusions. Our results suggest that women with confirmed CIN 1 have low rates of progression to high-grade CIN within 3 years. Because the median time to progression was 25 months, conservative management could recommend the next repeat cytology at 2 years.",
keywords = "cervical intraepithelial neoplasia, CIN, low-grade abnormalities, colposcopy, human papillomavirus (HPV), RISK, abnormalities, borderline, strategies, cytology, grade-3, lesions, trial",
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T1 - Postcolposcopy Management of Women With Histologically Proven CIN 1

T2 - Results From TOMBOLA

AU - Gurumurthy, Mahalakshmi

AU - Cotton, Seonaidh C.

AU - Sharp, Linda

AU - Smart, Louise

AU - Little, Julian

AU - Waugh, Norman

AU - Cruickshank, Margaret E.

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N2 - Objectives. This study aimed to determine during 36 months of follow-up the (1) clinical outcomes and (2) influence of high-risk human papillomavirus (HPV) status on the risk of progression to cervical intraepithelial neoplasia 2+ (CIN 2+), amongwomen with histologically proven CIN 1.Materials and Methods. This is an ad hoc analysis of women with CIN 1 within TOMBOLA, a randomized trial of the management of women with low-grade cervical cytology. Women from the colposcopy arm with CIN 1 confirmed on punch biopsies and managed conservatively by cytology every 6 months in primary care were included. Sociodemographic data and a sample for HPV testing were collected at recruitment. Data on the sample women were extracted to calculate the cumulative incidence of CIN 2+ and the performance characteristics of the baseline HPV test. Detection of CIN 2 or worse (CIN 2+) during follow-up or at exit colposcopy was analyzed.Results. A total of 171 women were included. Their median age was 29 years. Fifty-two percent were high-risk HPV positive, 17% were HPV-16 positive, and 11% were HPV-18 positive. Overall, 21 women (12%) developed CIN 2+, with a median time to detection of 25 months. Factors associated with progression to CIN 2+ were presence of HPV-18 (relative risk = 3.04; 95% CI = 1.09Y8.44) and HPV-16 and/or HPV-18 at recruitment (relative risk = 3.98; 95% CI = 1.60Y9.90). The sensitivity and specificity of a combined HPV-16/HPV-18 test for the detection of CIN 2+ during 3 years were 58% and 78%, respectively.Conclusions. Our results suggest that women with confirmed CIN 1 have low rates of progression to high-grade CIN within 3 years. Because the median time to progression was 25 months, conservative management could recommend the next repeat cytology at 2 years.

AB - Objectives. This study aimed to determine during 36 months of follow-up the (1) clinical outcomes and (2) influence of high-risk human papillomavirus (HPV) status on the risk of progression to cervical intraepithelial neoplasia 2+ (CIN 2+), amongwomen with histologically proven CIN 1.Materials and Methods. This is an ad hoc analysis of women with CIN 1 within TOMBOLA, a randomized trial of the management of women with low-grade cervical cytology. Women from the colposcopy arm with CIN 1 confirmed on punch biopsies and managed conservatively by cytology every 6 months in primary care were included. Sociodemographic data and a sample for HPV testing were collected at recruitment. Data on the sample women were extracted to calculate the cumulative incidence of CIN 2+ and the performance characteristics of the baseline HPV test. Detection of CIN 2 or worse (CIN 2+) during follow-up or at exit colposcopy was analyzed.Results. A total of 171 women were included. Their median age was 29 years. Fifty-two percent were high-risk HPV positive, 17% were HPV-16 positive, and 11% were HPV-18 positive. Overall, 21 women (12%) developed CIN 2+, with a median time to detection of 25 months. Factors associated with progression to CIN 2+ were presence of HPV-18 (relative risk = 3.04; 95% CI = 1.09Y8.44) and HPV-16 and/or HPV-18 at recruitment (relative risk = 3.98; 95% CI = 1.60Y9.90). The sensitivity and specificity of a combined HPV-16/HPV-18 test for the detection of CIN 2+ during 3 years were 58% and 78%, respectively.Conclusions. Our results suggest that women with confirmed CIN 1 have low rates of progression to high-grade CIN within 3 years. Because the median time to progression was 25 months, conservative management could recommend the next repeat cytology at 2 years.

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KW - human papillomavirus (HPV)

KW - RISK

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KW - borderline

KW - strategies

KW - cytology

KW - grade-3

KW - lesions

KW - trial

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JO - Journal of Lower Genital Tract Disease

JF - Journal of Lower Genital Tract Disease

SN - 1089-2591

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ER -