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Obstetrics & Gynecology 2008;111:847-856
© 2008 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

An Analysis of High-Risk Human Papillomavirus DNA-Negative Cervical Precancers in the ASCUS-LSIL Triage Study (ALTS)

Philip E. Castle, PhD, MPH1, J. Thomas Cox, MD2, Jose Jeronimo, MD1, Diane Solomon, MD3, Cosette M. Wheeler, PhD4, Patti E. Gravitt, PhD, MS5 and Mark Schiffman, MD, MPH1

From the 1Division of Cancer Epidemiology and Genetics and 3Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland; 2Gynecology and Colposcopy Clinic Student Health Service, University of California, Santa Barbara, California; 4Departments of Molecular Genetics and Microbiology and Obstetrics and Gynecology, University of New Mexico Health Sciences Center, School of Medicine, Albuquerque, New Mexico; and 5Department of Epidemiology, Johns Hopkins University, Baltimore, Maryland.

OBJECTIVE: To describe women diagnosed with cervical intraepithelial neoplasia-grade 3 (CIN-3) diagnosed over the 2-year duration of the atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesion (LSIL) Triage Study (ALTS) that tested negative for high-risk human papillomavirus (HPV) at enrollment.

METHODS: Clinical center pathologists and quality control pathology group reviewed all histology; any CIN-3 diagnosis on biopsy or loop electrosurgical excision procedure (n=621) by at least one pathology review over the duration of ALTS led to inclusion in this analysis. Enrollment cervical specimens were tested for high-risk HPV DNA by two HPV assays; results were combined to minimize simple testing errors. We compared the characteristics of baseline high-risk HPV-negative (n=33) to baseline high-risk HPV-positive (n=588) cumulative diagnosed CIN-3.

RESULTS: High-risk HPV-negative CIN-3 cases were less likely to have a second, confirming diagnosis of CIN-3 (24% compared with 56%) by the other pathology group, were more likely to be diagnosed later in follow-up, and more likely to be referred into ALTS because of an ASCUS Pap test rather than an LSIL Pap. Upon review of case histories of the 33 baseline high-risk HPV-negative CIN-3 (5.3% of all cases), there was evidence that these cases were due to incident (new) cases (n=12, 1.9%), non–high-risk HPV (n=5, 0.8%), misclassified histology (n=8, 1.3%), and false-negative high-risk HPV (n=8, 1.3%).

CONCLUSION: In any sizeable population, even among women with evidence of cytologic abnormalities, there will be a few cases of cervical precancer that will test high-risk HPV negative for one or more reasons.

LEVEL OF EVIDENCE: II






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