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Clin Infect Dis. 2018 Jul 27. doi: 10.1093/cid/ciy615. [Epub ahead of print]

A randomized clinical trial of infrared coagulation ablation versus active monitoring of intra-anal high-grade dysplasia in HIV-infected adults: An AIDS Malignancy Consortium trial.

Author information

1
Icahn School of Medicine at Mount Sinai New York, NY.
2
University of Arkansas for Medical Sciences Little Rock, AR.
3
Department of Obstetrics and Gynecology Boston Medical Center Boston, MA.
4
Professor of Clinical Pathology UCSF Mt. Zion Medical Center Department of Pathology, San Francisco, CA.
5
Professor of Biostatistics University of Arkansas for Medical Sciences Little Rock, Arkansas.
6
UCSF San Francisco, CA.
7
UCSF ANCRE Center Mount Zion Hospital UCSF Box San Francisco, CA.
8
Clinical Professor of Medicine University of California, San Francisco Department of Hematology Oncology San Francisco, CA.
9
Associate Professor University of Vic Hospital Germans Trias i Pujol Badalona Spain.
10
Professor of Medicine David Geffen School of Medicine at UCLA UCLA CARE Center Los Angeles, CA.
11
Benaroya Research Institute Hematologist-Oncologist Seattle, WA.
12
Professor of Medicine UCSF San Francisco, CA.
13
Associate Professor of Medicine Cornell Clinical Trials Unit New York, NY.

Abstract

Background:

Anal high-grade dysplasia (HSIL) ablation may reduce the incidence of invasive cancer, but few data exist on HSIL treatment efficacy and natural regression without treatment.

Methods:

An open-label, randomized, multi-site clinical trial of HIV-infected adults age 27 or older with 1-3 biopsy-proven anal HSIL (index HSIL) without prior history of HSIL treatment with infrared coagulation. Participants were randomized 1:1 to ablation of anal HSIL with infrared coagulation (treatment group) or no HSIL treatment (active monitoring). Participants were followed every three months with high-resolution anoscopy. Treatment group participants underwent anal biopsies of suspected new or recurrent HSIL. Active monitoring arm participants only underwent biopsies at month 12. The primary endpoint was complete clearance of index HSIL at Month 12.

Results:

We randomized 120 participants. Complete index HSIL clearance occurred more frequently in the treatment group as compared to active monitoring group (62% vs. 30%; risk difference, 32%; 95% CI, 13%-48%; P<0.001). Complete or partial clearance (complete clearance of ≥1 index HSIL) occurred more commonly in the treatment group (82% vs. 47%; risk difference, 35%; 95% CI, 16%-50%; P<0.001). Having a single index lesion was significantly associated with complete clearance as compared to having 2-3 index lesions (RR, 1.96; 95% CI, 1.22-3.10). The most common adverse events related to treatment were mild or moderate anal pain and bleeding. No serious adverse events were deemed related to treatment or study participation.

Conclusion:

Infrared coagulation ablation of anal HSIL results in more clearance of HSIL compared to observation alone.

PMID:
30060087
DOI:
10.1093/cid/ciy615

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