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Cited by 181Colorectal and Anal CarcinomasCervical Cancer and HPV ResearchGenital Health and Disease

The DOI matches its Crossref record; 29 of the 29 references it cites were found in a registry or an index.

Comparison of imiquimod, topical fluorouracil, and electrocautery for the treatment of anal intraepithelial neoplasia in HIV-positive men who have sex with men: an open-label, randomised controlled trial.

Richel, Olivier, de Vries, Henry JC, van Noesel, Carel JM, Dijkgraaf, Marcel GW, Prins, Jan M·2013·The Lancet Oncology
DOI 10.1016/s1470-2045(13)70067-6
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Abstract

Background Anal cancer is an increasing issue in HIV-positive men who have sex with men (MSM). Screening for its precursor, anal intraepithelial neoplasia (AIN), is subject of discussion. Current treatment options are suboptimum and have not been compared in a prospective trial. We compared efficacy and side-effects of imiquimod, topical fluorouracil, and electrocautery for the treatment of AIN.Methods In this open-label randomised trial, we included HIV-positive MSM older than 18 years visiting the HIV outpatient clinic of the Academic Medical Center, Amsterdam, Netherlands. Patients with histologically confirmed AIN were randomly assigned to receive either 16 weeks of imiquimod (three times a week), 16 weeks of topical fluorouracil (twice a week), or monthly electrocautery for 4 months. Randomisation was done with random block sizes of three and six, stratified for AIN grade (AIN grades 1, 2, or 3) and AIN location (peri-anal or intra-anal). Participants were assessed by high-resolution anoscopy 4 weeks after treatment. Responding patients returned for follow-up 24 weeks, 48 weeks, and 72 weeks after treatment. The primary endpoint was histological resolution of AIN measured 4 weeks after treatment and AIN recurrence at week 24, week 48, and week 72 after treatment. The primary analysis was done in a modified intention-to-treat population, including all patients who had received their assigned treatment at least once. The trial is registered at the Netherlands Trial Register, number NTR1236.Findings Between Aug 12, 2008, and Dec 1, 2010, we screened 388 HIV-positive MSM for AIN by high resolution anoscopy. Of the 246 (63%) patients who had AIN, 156 (63%) were randomly assigned to either receive imiquimod (54 patients), topical fluorouracil (48 patients), or electrocautery (46 patients) following withdrawing of consent by eight patients. Modified intention-to-treat analysis showed a complete response in 13 (24%, 95% CI 15-37) patients in the imiquimod group, eight (17%, 8-30) of patients in the fluorouracil group, and 18 (39%, 26-54) of patients in the electrocautery group (p=0·027). At week 24, 11 (22%) of 50 responders had recurrence; at week 48, 22 (46%) of 48 had recurred; and at week 72, 30 (67%) of 45 had recurred. Recurrence was observed at 72 weeks in 10 (71%) of 14 patients treated with imiquimod, seven (58%) of 12 patients treated with fluorouracil, and 13 (68%) of 19 patients treated with electrocautery. Grade 3-4 side-effects were noted in 23 (43%) of 53 patients in the imiquimod group, 13 (27%) of 48 patients in the fluorouracil group, and eight (18%) patients in the electrocautery group (p=0·019). The most common side-effects were pain, bleeding, and itching. Seven serious adverse events occurred, all not related to the study.Interpretation Electrocautery is better than imiquimod and fluorouracil in the treatment of AIN, but recurrence rates are substantial.Funding Anna Maurits de Cock foundation provided funding for the video colposcope.

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Crossref · 10.1016/s1470-2045(13)70067-6

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  • Recurrence rates with both provider-applied and patient-applied treatments for anal HSIL are high, ranging from approximately 50% at 1 year to 77% after 3 years.

    “Recurrence rates with both provider-applied and patient-applied treatments are high, ranging from approximately 50% at 1 year to 77% after 3 years (1289,1292,1293).”

    From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [1292]

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Research works printed but not linked: 5

  1. Jay N, Berry JM, Darragh T, Palefsky J. Treatment of diffuse highgrade anal intraepithelial neoplasia with 5%-fluorouracil cream. 25th International Papillomavirus Conference; Malmö, Sweden, 2009. Abstr P–19.16.
  2. Salit IE, Tinmouth J, Raboud J, Blitz S, Sano M, Collins E. Progression of anal dysplasia in the TRACE study. International Papillomavirus Conference 2012; San Juan, Puerto Rico; Nov 30–Dec 6, 2012. Poster EP-507.
  3. Goldie, 1999, The clinical effectiveness and cost-effectiveness of screening for anal squamous intraepithelial lesions in homosexual and bisexual HIV-positive men, JAMA, 281, 1822, 10.1001/jama.281.19.1822 · DOI
  4. Chin-Hong, 2002, Natural history and clinical management of anal human papillomavirus disease in men and women infected with human immunodeficiency virus, Clin Infect Dis, 35, 1127, 10.1086/344057 · DOI
  5. Fox, 2003, Lack of response of anal intra-epithelial neoplasia to highly active antiretroviral therapy, AIDS, 17, 279, 10.1097/00002030-200301240-00028 · DOI

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Metadata

Authors
Richel, O., de Vries, H. J., van Noesel, C. J., Dijkgraaf, M. G., & Prins, J. M.
Affiliations
Amsterdam UMC Location University of Amsterdam (NL)
Corresponding author
Richel, Olivier
ORCID
Venue
The Lancet Oncology
Publisher
Elsevier BV
Published
2013-04
Volume
14
Issue
4
Pages
346-353
ISSN
1470-2045 (ISSN-L)
DOI
10.1016/s1470-2045(13)70067-6
OpenAlex
W2124385271
Cited by
181
References
29
Citations by year
2026: 9 · 2025: 16 · 2024: 8 · 2023: 14 · 2022: 12 · 2021: 11 · 2020: 12 · 2019: 16 · 2018: 16 · 2017: 17 · 2016: 14 · 2015: 17 · 2014: 12 · 2013: 6
FWCI
16.09
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • The Lancet Oncology (publishedVersion)
  • PubMed (publishedVersion)
  • Data Archiving and Networked Services (DANS) (submittedVersion)
  • Pure Amsterdam UMC (submittedVersion)
Topics
  • Health Sciences › Medicine › Surgery › Colorectal and Anal Carcinomas
  • Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
  • Health Sciences › Medicine › Surgery › Genital Health and Disease
Keywords
anal intraepithelial neoplasia, HIV-positive men who have sex with men, imiquimod, topical fluorouracil, electrocautery, anal cancer prevention, high-resolution anoscopy, treatment efficacy and safety, anal cancer screening, immunotherapy, topical chemotherapy
MeSH terms
Imiquimod, Aminoquinolines, Anus Neoplasms, Carcinoma in Situ, Electrocoagulation, Fluorouracil, HIV, HIV Seropositivity, Humans, Male, Middle Aged, Netherlands, Prospective Studies, HIV Infections, Homosexuality, Male, Papillomaviridae

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