Researchers said that infrared coagulation ablation of anal canal high-grade squamous intraepithelial lesions, or HSILs, is more likely to result in a complete or partial resolution of HSILs than monitoring alone in patients living with HIV, according to the results of a randomized clinical trial.
“The overall strength of this study rests on the fact that it is the first multicenter, prospective, randomized trial powered to determine whether or not HSIL ablation is superior to [active monitoring] alone in clearing HSIL in HIV-infected individuals,” Stephen E. Goldstone, MD, assistant clinical professor in surgery at the Icahn School of Medicine at Mount Sinai, and colleagues wrote in Clinical Infectious Diseases.
For the study, researchers looked at an open-label, randomized, multisite clinical trial of HIV-infected adults, a population with substantially higher risks for certain types of cancer, with 1-3 biopsy-proven anal HSIL and without prior history of HSIL treatment with infrared coagulation. Participants in the study were randomly assigned, in a 1:1 ratio, to two groups: a treatment group that received ablation of anal HSIL with infrared coagulation (IRC) and an active monitoring group that received no HSIL treatment.
Those in the treatment group were seen every 3 months for digital anorectal exams (DARE), anal cytology, and high-resolution anoscopy (HRA) with biopsies of suspected new or recurrent HSILs. Biopsy-proven recurrent or metachronous HSILs were treated within 4 weeks. Participants assigned to active monitoring were examined by DARE, anal cytology and HRA every 3 months. Anal biopsies for those in the active monitoring group were obtained only for lesions believed to be progressing to invasive cancer.
The study showed that complete index HSIL clearance occurred more frequently in the treatment group compared with the active monitoring group — a 62% vs. 30% comparison. Complete or partial clearance also occurred more commonly in the treatment group — an 82% vs. 47% occurrence, according to the study.
At 12 months, 87% of participants in the treatment group and 95% in the active monitoring group returned with evaluable biopsies, researchers said. Additionally, 62% of those in the treatment group had a no index lesion recurrence compared with 30% of the active monitoring group.
Researchers concluded that treatment group participants “had a significantly superior outcome.”
Results were similar at 24 months, with 83% of the 30 participants from the treatment group achieving a no index lesion recurrence and 83% of the 25 participants from the active monitoring group achieving no index lesion recurrence.
Researchers learned that having a single index lesion was significantly associated with complete clearance compared with having two to three index lesions. The most common adverse events related to treatment, the researchers wrote, were mild or moderate anal pain and bleeding. No serious adverse events were deemed related to treatment or study participation, they noted, and no participants progressed to cancer.
“IRC ablation of anal canal HSIL is more likely to result in a complete or partial resolution of HSIL than [active monitoring] alone in those with small and fewer lesions,” the researchers wrote. “Future studies should identify more effective treatment options so that a greater number of patients can be effectively treated with a single intervention.”
By Caitlyn Stulpin
Anal cancer remains a serious concern for men who have sex with men and especially for those with HIV. Although the methods of detection of cytologic changes has become more standardized, the management of high grade dysplasia is still under active investigation. This paper reports the results of a prospective randomized trial under the sponsorship of the NCI-funded AIDS Malignancy Consortium and compared ablation of high-grade lesions with infrared coagulation ablation to a control group that was monitored but untreated. The treatment was well-tolerated and associated with a 50% increase in complete resolution of HSIL — from 30% in the control arm to 62% in the treated group. Unsurprisingly, complete clearance was more common in persons with a single lesion vs. those with multiple lesions. These results are quite promising, and we look forward to further exploration of his treatment in larger population studies.