Treatment of Anal High-Grade Squamous Intraepithelial Lesions to Prevent Anal Cancer
Treatment of anal high‑grade squamous intraepithelial lesions in HIV‑positive adults reduces progression to anal cancer by 57% compared with active monitoring.
The incidence of anal cancer is substantially higher among persons living with the human immunodeficiency virus (HIV) than in the general population. Similar to cervical cancer, anal cancer is preceded by high‑grade squamous intraepithelial lesions (HSILs). Treatment for cervical HSIL reduces progression to cervical cancer; however, data from prospective studies of treatment for anal HSIL to prevent anal cancer are lacking. We conducted a phase 3 randomized controlled trial at 25 U.S. sites enrolling HIV‑positive adults with biopsy‑proven anal HSIL. Participants were randomly assigned to immediate HSIL treatment or active monitoring. The primary outcome was progression to anal cancer. With a median follow‑up of 25.8 months, 9 participants in the treatment group and 21 in the active‑monitoring group developed anal cancer, yielding an adjusted hazard ratio of 0.43 (P = 0.03). This demonstrates that HSIL treatment significantly reduces the incidence of anal cancer in this high‑risk population.
Anal cancer carries a high morbidity and mortality burden. Prevention of anal cancer through HSIL treatment could substantially reduce disease incidence and improve survival in HIV‑positive individuals, for whom the risk is markedly elevated.
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