CLINICAL SCIENCE Infrared Coagulator Treatment of High-Grade Anal Dysplasia in HIV-Infected Individuals An AIDS Malignancy Consortium Pilot Study Elizabeth A. Stier, MD,* Stephen E. Goldstone, MD,† J. Michael Berry, MD,‡ Lori A. Panther, MD,§ Naomi Jay, PhD,‡ Susan E. Krown, MD, k Jeannette Lee, PhD,¶ and Joel M. Palefsky, MD‡ Objective: To evaluate prospectively the safety of the infrared coagulator (IRC) as a treatment for anal high-grade squamous intraepithelial lesions (HSILs) in HIV-infected individuals and to seek preliminary evidence for efficacy. Methods: HIV-infected patients with #3 biopsy-proven internal anal HSILs received office-based treatment with the IRC at participa- ting AIDS Malignancy Consortium sites. Treatments were performed during high-resolution anoscopy (HRA) under local anesthesia. Patients were reevaluated at 3 months, and persistent lesions could be retreated. Patients were evaluated every 3 months for a year with anal cytology and HRA with biopsy. Human papillomavirus (HPV) DNA was measured at baseline and at follow-up using MY09/MY11 L1 polymerase chain reaction. Results: A total of 44 HSILs were treated from 16 men and 2 women. HPV 16 was the most common HPV type identified. There was no consistent change in HPV type or viral load in patients before and after treatment with the IRC. No procedure-related severe adverse events were reported. Twelve patients reported mild or moderate anal/rectal pain or bleeding. Conclusions: The IRC is a well-tolerated method of treating discrete anal canal HSILs in HIV-infected patients. A larger study to characterize its efficacy better in the management of HSILs in HIV- infected individuals is warranted. Key Words: anal dysplasia, HIV infection, human papilloma virus (J Acquir Immune Defic Syndr 2008;47:56–61) I nvasive anal cancers are a significant cause of morbidity among HIV-infected individuals. Like cervical cancers, anal cancers are believed to arise from intraepithelial lesions caused by oncogenic human papillomavirus (HPV). The marked decrease in cervical cancer incidence and mortality rates over the past 4 decades has been attributed to detection of preinvasive high-grade squamous intraepithelial lesions (HSILs) by cervical cytology and to treatment of these le- sions, thereby preventing progression to invasive cervical cancer. 1 In recent years, methods used to detect preinvasive cervical lesions have been adapted to evaluate the anal epi- thelium, namely, anal cytology 2 and high-resolution anoscopy (HRA). 3 These sensitive methods have detected HSILs of the anal canal in up to 52% of HIV-infected men who have sex with men. 4 Because cervical and anal epithelia show similar biology, it has been hypothesized that detection and treatment of HSIL of the anus may prevent progression to invasive anal cancer. The most effective treatment for HSIL of the cervix—excision of the transformation zone of the cervix with a conization procedure—is not an option for treatment of anal lesions, because excision of large sections of the anal canal may be associated with anal stenosis, abscess, anal spasm, and dyschezia. Cervical dysplasia can also be treated with ablative procedures such as laser or cryotherapy. In many centers, targeted excision and/or ablation with a laser, cryotherapy, or cautery is also standard treatment for HSIL of the anus. Chang et al 5 prospectively evaluated the surgical outcomes of patients with large-volume HSILs treated with a combination of exci- sion and cauterization. Although tolerance of the procedure was reported to be generally good, approximately half of the patients reported ‘‘uncontrolled pain’’ for an average of 2.9 weeks. In addition, of the 29 HIV-infected patients, 23 (79%) showed recurrent HSILs after a mean of 12 months. The infrared coagulator (IRC), which is approved by the US Food and Drug Administration for the treatment of hemorrhoids, tattoo removal, chronic rhinitis, and genital warts, has been suggested as an alternative method for out- patient treatment of anal HSIL. 6 The IRC relies on the delivery of short pulses of a narrow beam of visible and infrared light through a small contact tip applicator that is applied directly to the target tissue, resulting in thermal coagulation and tissue necrosis. The depth of coagulation and tissue necrosis is precisely adjustable. Received for publication June 4, 2007; accepted August 13, 2007. From the *Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, NY; †Department of Surgery, Mt. Sinai School of Medicine, New York, NY; ‡Department of Medicine, University of California, San Francisco, CA; §Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA; k Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY; and the {Department of Medicine, University of Alabama, Birmingham, AL. Supported by cooperative agreements from the National Cancer Institute U01CA70019, U01CA70054, U01CA071375, U01CA070047, and U01CA121947. Correspondence to: Elizabeth A. Stier, MD, Department of Obstetrics and Gynecology, Boston Medical Center, 85 East Concord Street, Sixth Floor, Boston, MA 02118 (e-mail: elizabeth.stier@bmc.org). Copyright Ó 2007 by Lippincott Williams & Wilkins 56 J Acquir Immune Defic Syndr  Volume 47, Number 1, January 1, 2008 Copyright © 2007 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.