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Findings to date from the ASCUS-LSIL Triage Study (ALTS)
Mark Schiffman1, Diane Solomon
1Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Rockville, Md 20852, USA. schiffmm@mail.nih.gov
Archives of Pathology & Laboratory Medicine
|July 23, 2003
Summary
Human papillomavirus (HPV) DNA testing effectively triages atypical squamous cells of undetermined significance (ASCUS), reducing colposcopy referrals. However, HPV testing is not ideal for low-grade squamous intraepithelial lesions (LSIL).
Area of Science:
- Gynecologic Oncology
- Cervical Cancer Screening
- Diagnostic Cytology
Background:
- Management of atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesions (LSIL) in cervical cytology is controversial.
- The National Cancer Institute's ASCUS-LSIL Triage Study (ALTS) was initiated to evaluate management strategies for these cytologic interpretations.
Purpose of the Study:
- To evaluate three management methods for ASCUS and LSIL: immediate colposcopy, cytologic follow-up, and human papillomavirus (HPV) DNA testing triage.
- To assess the effectiveness of HPV DNA testing in triaging women with ASCUS and LSIL for colposcopy referral.
Main Methods:
- Multicenter, randomized clinical trial involving 3488 patients with ASCUS and 1572 patients with LSIL.
- Participants were randomly assigned to immediate colposcopy, cytologic follow-up, or HPV DNA testing triage.
- Patients were monitored for 2 years, with the primary outcome being histologic cervical intraepithelial neoplasia (CIN) 3 or cancer.
Main Results:
- HPV DNA testing was not effective for triaging LSIL due to high oncogenic HPV prevalence.
- For ASCUS, HPV triage demonstrated sensitivity equivalent to immediate colposcopy, reducing colposcopic referrals by half.
- HPV testing remained sensitive for detecting CIN 3/cancer in older women with ASCUS, with significantly fewer referrals compared to younger women.
- Significant inter-observer variability was observed among pathologists interpreting cervical abnormalities, particularly for histologic CIN 1 and cytologic ASCUS.
- A specific subtype of ASCUS, equivocal for high-grade squamous intraepithelial lesion, was identified as having a high positive predictive value for underlying high-grade CIN.
Conclusions:
- Human papillomavirus (HPV) DNA testing is a valuable triage tool for women with ASCUS, significantly reducing unnecessary colposcopic referrals.
- HPV testing is not suitable for triaging LSIL due to high HPV prevalence.
- The ALTS study provided critical insights into the performance of cervical cytology and histopathology, highlighting diagnostic variability and identifying specific ASCUS subtypes predictive of high-grade disease.
