2025/02/27 by Joaquín Burgos, Adrián Curran, Jorge García +10 · 1 voice
Medicine · #Cervical Cancer and HPV Research #Colorectal and Anal Carcinomas #HIV/AIDS oral health manifestations
paper · doi:10.1093/cid/ciaf086
openalex publication_date 2025/02/27 · openalex created_date 2025/10/10 · openalex updated_date 2026/07/28
BACKGROUND: Doubts remain about the best treatment for managing premalignant lesions (high-grade squamous intraepithelial lesions [HSIL]) associated with anal cancer. METHODS: The TREATAIN trial was an open-label, randomized study conducted at Hospital Vall d'Hebron (Spain). Persons with human immunodeficiency virus and anal HSIL were randomly assigned 1:1:1 to receive treatment with electrocautery, topical cidofovir 1% ointment, or topical sinecatechins 10%. The primary outcome was histological resolution of HSIL. Secondary outcomes included adverse events, participant satisfaction, human papillomavirus clearance, and HSIL recurrence. RESULTS: Between October 2020 and November 2022, 100 participants were enrolled (36 in the electrocautery arm, 28 in the cidofovir arm, and 36 in the sinecatechins arm). Modified intention-to-treat analysis showed a response rate of 69.4% (95% confidence interval [CI]: 54.4%-84.5%) of patients in the electrocautery group, 82.1% (95% CI: 67.9%-96.3%) in the cidofovir group, and 61.1% (95% CI: 45.2%-77%) in the sinecatechins group (P = .189). During the 48-week follow-up period, recurrence was observed in 7 participants (28%) in the electrocautery group, 7 (30.4%) in the cidofovir group, and 8 (36.4%) in the sinecatechins group (log-rank test, P = .811). Side effects were reported by 97.2% of patients in the electrocautery group, 85.7% in the cidofovir group, and 33% in the sinecatechins group (P < .001). Patients were more satisfied with the sinecatechins treatment (mean, 5.6 ± 0.4), followed by electrocautery (mean, 5.1 ± 0.8), while lower satisfaction was reported with cidofovir treatment (mean, 4.77 ± 0.96) (P < .001). CONCLUSIONS: No statistically significant difference was observed in efficacy between treatments; in contrast, sinecatechins was the most accepted and well-tolerated treatment. Clinical Trials Registration. EudraCT: 2018-001730-18; ClinicalTrials.gov: NCT04055142.