6/28/23, 12:39 AM ANCHOR Pathway Feedback Search Clinical Topics Home Studies ANCHOR ANCHOR Disease Disease Anal cancer Human immunodeficiency virus i 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 N = 4446 83.3% male 4446 patients (711 female, 3575 male) Inclusion criteria: adult patients 35 years of age living with human immunodeficiency virus 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) https://web.pathway.md/studies/recYwiFjcK0vSVPTA 1/2 6/28/23, 12:39 AM ANCHOR Pathway Primary outcome Progression to anal cancer 402.0 per 10 402 301.5 per 10 201.0 per 10 173 100.5 per 10 Significant decrease 0.0 per 10 Treatment Active-monitoring 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 human immunodeficiency virus 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. Open reference URL https://web.pathway.md/studies/recYwiFjcK0vSVPTA 2/2