Post-treatment CIN: randomised clinical trial using hrHPV testing for prediction of residual/recurrent disease

TY - JOUR

T1 - Post-treatment CIN

T2 - randomised clinical trial using hrHPV testing for prediction of residual/recurrent disease

AU - Bais, Aagje G

AU - Eijkemans, Marinus J C

AU - Rebolj, Mateja

AU - Snijders, Peter J F

AU - Verheijen, René H M

AU - van Ballegooijen, Marjolein

AU - Meijer, Chris J L M

AU - Helmerhorst, Theo J M

AU - Rebolj, Matejka

PY - 2009/2/15

Y1 - 2009/2/15

N2 - We investigated in a randomised clinical trial whether addition of hrHPV testing (high-risk human papillomavirus) to cytological follow-up after treatment for high-grade CIN (cervical intraepithelial neoplasia 2/3) can lead to a better selection of women at risk for residual/recurrent CIN. We included 210 women with high-grade CIN undergoing treatment in outpatient clinics in The Netherlands. Follow-up was based on cytology alone and cytology combined with hrHPV detection. Our primary outcome measurement was improving specificity for residual/recurrent CIN after treatment. Secondary, we compared health-care costs and impact of individual hrHPV type on the risk of residual/recurrent CIN. Follow-up by abnormal cytology alone (6, 12 and 24 months after treatment according to the Dutch protocol) showed a lower specificity for detection of residual/recurrent CIN than follow-up by abnormal cytology and presence of hrHPV (80 vs. 91%, relative risk 0.87 (95% CI 0.77-0.99)). Both methods showed no significant difference in sensitivity ((86 vs. 100%) RR 0.86 (95% CI 0.63-1.16)). Comparing different post hoc modifications in the strategy of combined testing showed similar test characteristics when low-risk women (normal cytology and hrHPV negative at 6 months) omitted the 12 months visit (specificity 91%, p = 1.00 z = 0.00). Prediction of residual/recurrent CIN by typing of hrHPV could not be confirmed. Total health-care costs using cytology and hrHPV testing during follow-up decreased when low-risk women omit the 12 months visit. Follow-up after treatment for high-grade CIN can be improved by combining cytology with hrHPV testing. We advise combined cytology and hrHPV testing at 6, 12 and 24 months after treatment. Low-risk women may omit the 12 months visit, resulting in cost reduction.

AB - We investigated in a randomised clinical trial whether addition of hrHPV testing (high-risk human papillomavirus) to cytological follow-up after treatment for high-grade CIN (cervical intraepithelial neoplasia 2/3) can lead to a better selection of women at risk for residual/recurrent CIN. We included 210 women with high-grade CIN undergoing treatment in outpatient clinics in The Netherlands. Follow-up was based on cytology alone and cytology combined with hrHPV detection. Our primary outcome measurement was improving specificity for residual/recurrent CIN after treatment. Secondary, we compared health-care costs and impact of individual hrHPV type on the risk of residual/recurrent CIN. Follow-up by abnormal cytology alone (6, 12 and 24 months after treatment according to the Dutch protocol) showed a lower specificity for detection of residual/recurrent CIN than follow-up by abnormal cytology and presence of hrHPV (80 vs. 91%, relative risk 0.87 (95% CI 0.77-0.99)). Both methods showed no significant difference in sensitivity ((86 vs. 100%) RR 0.86 (95% CI 0.63-1.16)). Comparing different post hoc modifications in the strategy of combined testing showed similar test characteristics when low-risk women (normal cytology and hrHPV negative at 6 months) omitted the 12 months visit (specificity 91%, p = 1.00 z = 0.00). Prediction of residual/recurrent CIN by typing of hrHPV could not be confirmed. Total health-care costs using cytology and hrHPV testing during follow-up decreased when low-risk women omit the 12 months visit. Follow-up after treatment for high-grade CIN can be improved by combining cytology with hrHPV testing. We advise combined cytology and hrHPV testing at 6, 12 and 24 months after treatment. Low-risk women may omit the 12 months visit, resulting in cost reduction.

KW - Adult

KW - Cervical Intraepithelial Neoplasia

KW - Cervix Uteri

KW - DNA, Viral

KW - Female

KW - Follow-Up Studies

KW - Humans

KW - Middle Aged

KW - Papillomaviridae

KW - Papillomavirus Infections

KW - Recurrence

KW - Risk

KW - Time Factors

KW - Treatment Outcome

KW - Vaginal Smears

U2 - 10.1002/ijc.23824

DO - 10.1002/ijc.23824

M3 - Journal article

C2 - 19048594

SN - 0020-7136

VL - 124

SP - 889

EP - 895

JO - Radiation Oncology Investigations

JF - Radiation Oncology Investigations

IS - 4

ER -