Efficacy and safety of topical trichloroacetic acid vs. electrocautery for the treatment of anal intraepithelial neoplasia in HIV-positive patients (TECAIN): a randomized controlled trial
BACKGROUND: Screening for and treatment of anal intraepithelial neoplasia (AIN) as anal cancer precursor lesions are recommended in guidelines for people living with HIV (PLHIV). Current treatment options are suboptimal and data from prospective trials is limited.
METHODS: The TECAIN Study is a randomized, unblinded, multicenter trial investigating the efficacy and safety of electrocautery (ECA) as standard of care vs. topical application of trichloroacetic acid (TCA) for the treatment of AIN diagnosed with high-resolution anoscopy (HRA) and targeted biopsies. PLHIV with histologically confirmed AIN were recruited from HIV-outpatient clinics with specialised proctologic care in Germany. The primary efficacy endpoint was therapeutic success defined as clinically and histologically confirmed resolution (or regression) of AIN marker lesions 4 weeks (FU4) after the last treatment of a maximum of 4 interventions every 4 weeks within 16 weeks since randomization. Secondary endpoints were the number of interventions, adverse events (AE) and recurrence of AIN 24 weeks after the end of TECAIN treatment (FU24).
RESULTS: 155 PLHIV (98.1% males, 81% MSM, mean age 48.6 ± 10.6 (SD) years, mean CD4 count 637 ± 291.1 (SD) cells/µl) with AIN grade I (42.6%) or high-grade AIN (57.4%) were evaluated so far. 76 PLHIV were treated with ECA and 79 with TCA. Treatment success as defined by the protocol was demonstrated in 67% of the ECA-group (after a mean of 2.3 interventions) and in 61% of the TCA-group (after a mean of 2.6 interventions) (p=0.34). Clinical resolution of AIN was diagnosed in 85% and 77% of the ECA-group and in 78% and 79% of the TCA-group at FU4 and FU24, respectively. Histological resolution or regression were documented in 75% and 70% of the ECA-group compared to 74% and 65% of the TCA-group at FU4 and FU24, respectively. AEs were reported in 87.3% of the ECA- and in 93.4% of the TCA-group until FU24, without any persistent conditions. Serious AEs were reported in seven patients from each group, with only one event classified as probably treatment-associated, respectively.
CONCLUSIONS: This is the first prospective, randomized study demonstrating comparable outcomes of TCA and ECA for the treatment of AIN in PLHIV.
S. Esser * (1), A. Kreuter (2), A. Potthoff (3), N.H. Brockmeyer (3), M. Oette (4), K. Bilbilis (5), H. Lax (5), K.-H. Jöckel (5), D. Schadendorf (1), U. Wieland (6), TECAIN Study Group.
(1) University Hospital Essen, Department of Dermatology and Venerology, Essen, Germany, (2) University Witten/Herdecke, Helios St. Elisabeth Hospital Oberhausen, Department of Dermatology, Venerologie and Allergology, Oberhausen, Germany, (3) Ruhr-University Bochum, Department of Dermatology, Venerology and Allergology, Bochum, Germany, (4) Augustinerinnen Hospital, Department of Gastroenterology, Hepatology and Infectiology, Köln, Germany, (5) University Duisburg-Essen, Institute for Medical Informatics, Biometry and Epidemiology (IMIBE), Essen, Germany, (6) University of Cologne, Institute of Virology, National Reference Center for Papilloma- and Polyomaviruses, Cologne, Germany