Abstract
PURPOSE: The Anal Cancer/High-grade squamous intraepithelial lesions Outcomes Research (ANCHOR) trial demonstrated that treating precancerous anal HSIL reduces the incidence of anal cancer by 57% in people with HIV. It remains unclear how HSIL treatment or monitoring without treatment affects patient-reported health-related quality of life (HRQoL). We evaluated differences in HRQoL for individuals who were randomly assigned to active monitoring (AM) or treatment for anal HSIL. METHODS: Using an index designed and validated for use in ANCHOR, HRQoL was assessed before random assignment (T1), 2-7 days (+3 days) after random assignment/treatment (T2), and 28 days (±7 days) after random assignment/treatment (T3). RESULTS: ANCHOR participants living with HIV (N = 124; mean [standard deviation, SD] age, 52.6 years [10.3]; n = 101 [81.5%] men; n = 65 [52.4%] White; n = 95 [76.6%] non-Hispanic; treatment n = 70 [56.4%]; and AM n = 54 [43.6%]) were included. Treatment arm participants had significant mean worsening from T1-T2 in physical symptoms (mean [SD] difference, 0.31 [0.51]; P = .0001) and impact on psychological functioning (mean [SD] difference, 0.25 [0.64]; P = .022) that significantly improved to T1 levels from T2-T3 (ie, mean [SD] difference, -0.25 [0.52]; P = .003; and mean [SD] difference, -0.07 [0.23]; P = .039, respectively). AM arm participants experienced significant mean improvement in impact on psychological functioning from T1-T3 (mean [SD], difference, -0.20 [0.50]; P = .017). After adjusting for T1, treatment arm participants had a larger mean improvement than AM arm participants in physical symptoms from T2-T3 (mean [SD] difference, -0.25 [0.52]; P = .024); no between-arm differences were observed for impact on physical or psychological functioning. CONCLUSION: Treatment arm participants experienced significant worsening in physical symptoms and impact on psychological functioning from T1-T2 but returned to prerandomization levels by T3, indicating that any immediate anal HSIL treatment-related impacts to HRQoL are temporary. Further research is needed to determine long-term impacts of anal HSIL treatment on HRQoL.