NCCN Categories of Evidence and Consensus
Category 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
Category 2B: Based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate.
Category 3: Based upon any level of evidence, there is major NCCN disagreement that the intervention is appropriate.
All recommendations are category 2A unless otherwise noted.
Clinical trials: NCCN believes that the best management for any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Johnson LG, Madeleine MM, Newcomer LM et al.. Anal cancer incidence and survival: the Surveillance, Epidemiology, and End Results experience, 1973–2000. Cancer 2004;101:281–288.
Daling JR, Madeleine MM, Johnson LG et al.. Human papillomavirus, smoking, and sexual practices in the etiology of anal cancer. Cancer 2004;101:270–280.
Frisch M, Glimelius B, van den Brule AJ et al.. Sexually transmitted infection as a cause of anal cancer. N Engl J Med 1997;337:1350–1358.
Jimenez W, Paszat L, Kupets R et al.. Presumed previous human papillomavirus (HPV) related gynecological cancer in women diagnosed with anal cancer in the province of Ontario. Gynecol Oncol 2009;114:395–398.
Sunesen KG, Norgaard M, Thorlacius-Ussing O, Laurberg S. Immunosuppressive disorders and risk of anal squamous cell carcinoma: a nationwide cohort study in Denmark, 1978–2005. Int J Cancer 2010;127:675–684.
Frisch M, Biggar RJ, Goedert JJ. Human papillomavirus-associated cancers in patients with human immunodeficiency virus infection and acquired immunodeficiency syndrome. J Natl Cancer Inst 2000;92:1500–1510.
De Vuyst H, Clifford GM, Nascimento MC et al.. Prevalence and type distribution of human papillomavirus in carcinoma and intraepithelial neoplasia of the vulva, vagina and anus: a meta-analysis. Int J Cancer 2009;124:1626–1636.
Hoots BE, Palefsky JM, Pimenta JM, Smith JS. Human papillomavirus type distribution in anal cancer and anal intraepithelial lesions. Int J Cancer 2009;124:2375–2383.
Palefsky JM, Holly EA, Ralston ML, Jay N. Prevalence and risk factors for human papillomavirus infection of the anal canal in human immunodeficiency virus (HIV)-positive and HIV-negative homosexual men. J Infect Dis 1998;177:361–367.
Patel P, Hanson DL, Sullivan PS et al.. Incidence of types of cancer among HIV-infected persons compared with the general population in the United States, 1992–2003. Ann Intern Med 2008;148:728–736.
Scholefield JH, Castle MT, Watson NF. Malignant transformation of high-grade anal intraepithelial neoplasia. Br J Surg 2005;92:1133–1136.
Berry JM, Palefsky JM, Jay N et al.. Performance characteristics of anal cytology and human papillomavirus testing in patients with high-resolution anoscopy-guided biopsy of high-grade anal intraepithelial neoplasia. Dis Colon Rectum 2009;52:239–247.
Park IU, Palefsky JM. Evaluation and management of anal intraepithelial neoplasia in HIV-negative and HIV-positive men who have sex with men. Curr Infect Dis Rep 2010;12:126–133.
Roark R. The need for anal dysplasia screening and treatment programs for HIV-infected men who have sex with men: a review of the literature. J Assoc Nurses AIDS Care 2011;22:433–443.
Scholefield JH, Harris D, Radcliffe A. Guidelines for management of anal intraepithelial neoplasia. Colorectal Dis 2011;13(Suppl 1):3–10.
Dillner J, Kjaer SK, Wheeler CM et al.. Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: randomised controlled trial. BMJ 2010;341:c3493.
Garland SM, Hernandez-Avila M, Wheeler CM et al.. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med 2007;356:1928–1943.
Palefsky JM, Giuliano AR, Goldstone S et al.. HPV vaccine against anal HPV infection and anal intraepithelial neoplasia. N Engl J Med 2011;365:1576–1585.
FDA licensure of bivalent human papillomavirus vaccine (HPV2, Cervarix) for use in females and updated HPV vaccination recommendations from the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep 2010;59:626–629.
Kreimer AR, Gonzalez P, Katki HA et al.. Efficacy of a bivalent HPV 16/18 vaccine against anal HPV 16/18 infection among young women: a nested analysis within the Costa Rica Vaccine Trial. Lancet Oncol 2011;12:862–870.
Ajani JA, Winter KA, Gunderson LL et al.. Fluorouracil, mitomycin, and radiotherapy vs fluorouracil, cisplatin, and radiotherapy for carcinoma of the anal canal: a randomized controlled trial. JAMA 2008;299:1914–1921.