ANCHOR
Trial question
Is the treatment of anal high-grade squamous intraepithelial lesions superior to active monitoring in patients with increased risk of anal cancer?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
16.7% female
83.3% male
N = 4446
4446 patients (711 female, 3575 male)
Inclusion criteria: adult patients ≥ 35 years of age living with HIV who had biopsy-proven anal high-grade squamous intraepithelial lesions
Key exclusion criteria: history of anal cancer; anal cancer detected at screening; receipt of immunomodulatory investigational agents within 4 weeks of randomization
Interventions
N=2227 treatment (office-based ablative procedures, ablation or excision under anesthesia, or the administration of topical fluorouracil or imiquimod)
N=2219 active-monitoring (examinations for clinical observation every 6 months and biopsy of visible lesions every 12 months)
Primary outcome
Progression to anal cancer
173
402
402.0 per 10...
301.5 per 10...
201.0 per 10...
100.5 per 10...
0.0 per 10...
Treatment
Active-monitoring
Significant decrease ▼
Significant decrease in progression to anal cancer (173 per 100,000 p-yrs vs. 402 per 100,000 p-yrs; RR 0.43, 95% CI 0.2 to 0.94)
Safety outcomes
No significant differences in adverse events, serious adverse events.
Conclusion
In adult patients ≥ 35 years of age living with HIV who had biopsy-proven anal high-grade squamous intraepithelial lesions, treatment was superior to active-monitoring with respect to progression to anal cancer.
Reference
Joel M Palefsky, Jeannette Y Lee, Naomi Jay et al. Treatment of Anal High-Grade Squamous Intraepithelial Lesions to Prevent Anal Cancer. N Engl J Med. 2022 Jun 16;386(24):2273-2282.
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