Is there a way to reduce the number of HIV patients developing anal cancer? This clinical trial has some positive results.
Anal cancer is a type of cancer that starts in the anus, the opening at the end of the rectum. It's a rare form of cancer, but its incidence is higher among people living with HIV. Like other types of cancer, early detection and treatment are crucial for better outcomes. Similar to cervical cancer, anal cancer is preceded by high-grade squamous intraepithelial lesions (HSILs). However, data from prospective studies of treatment for anal HSIL to prevent anal cancer are lacking.
To address this gap, a phase 3 trial was conducted in 25 U.S. sites. The study randomly assigned persons living with HIV who were 35 years of age or older and had biopsy-proven anal HSIL (high-grade squamous intraepithelial lesions) to receive either HSIL treatment or active monitoring without treatment.
The treatment for high-grade squamous intraepithelial lesions (HSIL) included office-based procedures, anesthesia-based ablation or excision, or the use of topical fluorouracil or imiquimod. Participants in the treatment group were treated until their HSIL was completely gone. All participants had high-resolution anoscopies every six months, and biopsies were done as needed.
Out of 4,459 participants, 4,446 were included in the analysis of cancer progression after an average follow-up of 25.8 months. Nine cases of anal cancer were diagnosed in the treatment group and 21 in the active-monitoring group. The risk of anal cancer was 57% lower in the treatment group than in the active-monitoring group. Among participants with biopsy-proven anal HSIL, the risk of anal cancer was significantly lower with treatment for anal HSIL than with active monitoring.