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References: Anal cancer

78 sources cited on this page. Links open the primary source.

  1. Gabriel WB. Squamous-cell Carcinoma of the Anus and Anal Canal: An Analysis of 55 Cases: (Section of Proctology). Proc R Soc Med. 1941;34(3):139-60. PubMedDOI
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  2. Nigro ND, Vaitkevicius VK, Considine B Jr. Combined therapy for cancer of the anal canal: a preliminary report. Dis Colon Rectum. 1974;17(3):354-6. PubMedDOI
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  3. Paradis P, Douglass HO Jr, Holyoke ED. The clinical implications of a staging system for carcinoma of the anus. Surg Gynecol Obstet. 1975;141(3):411-6. PubMed
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  4. Nigro ND, Vaitkevicius VK, Buroker T, Bradley GT, Considine B. Combined therapy for cancer of the anal canal. Dis Colon Rectum. 1981;24(2):73-5. PubMedDOI
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  5. Nigro ND. An evaluation of combined therapy for squamous cell cancer of the anal canal. Dis Colon Rectum. 1984;27(12):763-6. PubMedDOI
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  6. Daling JR, Weiss NS, Hislop TG, Maden C, Coates RJ, Sherman KJ, et al. Sexual practices, sexually transmitted diseases, and the incidence of anal cancer. N Engl J Med. 1987;317(16):973-7. PubMedDOI
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  7. Palmer JG, Shepherd NA, Jass JR, Crawford LV, Northover JM. Human papillomavirus type 16 DNA in anal squamous cell carcinoma. Lancet. 1987;2(8549):42. PubMedDOI
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  8. Ajani JA, Carrasco CH, Jackson DE, Wallace S. Combination of cisplatin plus fluoropyrimidine chemotherapy effective against liver metastases from carcinoma of the anal canal. Am J Med. 1989;87(2):221-4. PubMedDOI
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  9. Palmer JG, Scholefield JH, Coates PJ, Shepherd NA, Jass JR, Crawford LV, et al. Anal cancer and human papillomaviruses. Dis Colon Rectum. 1989;32(12):1016-22. PubMedDOI
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  10. Scholefield JH, Sonnex C, Talbot IC, Palmer JG, Whatrup C, Mindel A, et al. Anal and cervical intraepithelial neoplasia: possible parallel. Lancet. 1989;2(8666):765-9. PubMedDOI
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  11. Flam M, John M, Pajak TF, Petrelli N, Myerson R, Doggett S, et al. Role of mitomycin in combination with fluorouracil and radiotherapy, and of salvage chemoradiation in the definitive nonsurgical treatment of epidermoid carcinoma of the anal canal: results of a phase III randomized intergroup study. J Clin Oncol. 1996;14(9):2527-39. PubMedDOI
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  12. UKCCCR Anal Cancer Trial Working Party. Epidermoid anal cancer: results from the UKCCCR randomised trial of radiotherapy alone versus radiotherapy, 5-fluorouracil, and mitomycin. Lancet. 1996;348(9034):1049-54. PubMedDOI
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  13. Bartelink H, Roelofsen F, Eschwege F, Rougier P, Bosset JF, Gonzalez DG, et al. Concomitant radiotherapy and chemotherapy is superior to radiotherapy alone in the treatment of locally advanced anal cancer: results of a phase III randomized trial of the European Organization for Research and Treatment of Cancer Radiotherapy and Gastrointestinal Cooperative Groups. J Clin Oncol. 1997;15(5):2040-9. PubMedDOI
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  14. Frisch M, Glimelius B, van den Brule AJ, Wohlfahrt J, Meijer CJ, Walboomers JM, et al. Sexually transmitted infection as a cause of anal cancer. N Engl J Med. 1997;337(19):1350-8. PubMedDOI
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  15. Palefsky JM, Holly EA, Ralston ML, Jay N, Berry JM, Darragh TM. High incidence of anal high-grade squamous intra-epithelial lesions among HIV-positive and HIV-negative homosexual and bisexual men. AIDS. 1998;12(5):495-503. PubMedDOI
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  16. 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(2):361-7. PubMedDOI
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  17. Bonin SR, Pajak TF, Russell AH, Coia LR, Paris KJ, Flam MS, et al. Overexpression of p53 protein and outcome of patients treated with chemoradiation for carcinoma of the anal canal: a report of randomized trial RTOG 87-04. Radiation Therapy Oncology Group. Cancer. 1999;85(6):1226-33. PubMed
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  18. Faivre C, Rougier P, Ducreux M, Mitry E, Lusinchi A, Lasser P, et al. [5-fluorouracile and cisplatinum combination chemotherapy for metastatic squamous-cell anal cancer]. Bull Cancer. 1999;86(10):861-5. PubMed
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  19. Ajani JA, Winter KA, Gunderson LL, Pedersen J, Benson AB 3rd, Thomas CR Jr, et al. Fluorouracil, mitomycin, and radiotherapy vs fluorouracil, cisplatin, and radiotherapy for carcinoma of the anal canal: a randomized controlled trial. JAMA. 2008;299(16):1914-21. PubMedDOI
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  20. U.S. Food and Drug Administration, Center for Biologics Evaluation and Research. Approval letter, STN BL 125126/1895 (GARDASIL, Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant; Merck Sharp & Dohme Corp.), signed by Wellington Sun, M.D., dated 22 December 2010. The original fda.gov page is no longer online; read in the UNT CyberCemetery web-archive copy of the FDA approved-products page (archive timestamp 16 September 2012; page marked last updated 30 December 2010). Source
  21. U.S. Food and Drug Administration, Center for Biologics Evaluation and Research. Summary Basis for Regulatory Action - Gardasil, 3 December 2010, STN BL 125126/1895 (review committee chair Jeff Roberts, M.D.; submission 26 February 2010; PDUFA goal date 27 December 2010). Read in the UNT CyberCemetery web-archive copy (archive timestamp 16 September 2012; page marked last updated 10 January 2011); the original fda.gov page is no longer online. Source
  22. Northover J, Glynne-Jones R, Sebag-Montefiore D, James R, Meadows H, Wan S, et al. Chemoradiation for the treatment of epidermoid anal cancer: 13-year follow-up of the first randomised UKCCCR Anal Cancer Trial (ACT I). Br J Cancer. 2010;102(7):1123-8. PubMedDOI
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  23. Palefsky JM, Giuliano AR, Goldstone S, Moreira ED Jr, Aranda C, Jessen H, et al. HPV vaccine against anal HPV infection and anal intraepithelial neoplasia. N Engl J Med. 2011;365(17):1576-85. PubMedDOI
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  24. Gunderson LL, Winter KA, Ajani JA, Pedersen JE, Moughan J, Benson AB 3rd, et al. Long-term update of US GI intergroup RTOG 98-11 phase III trial for anal carcinoma: survival, relapse, and colostomy failure with concurrent chemoradiation involving fluorouracil/mitomycin versus fluorouracil/cisplatin. J Clin Oncol. 2012;30(35):4344-51. PubMedDOI
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  25. Peiffert D, Tournier-Rangeard L, Gérard JP, Lemanski C, François E, Giovannini M, et al. Induction chemotherapy and dose intensification of the radiation boost in locally advanced anal canal carcinoma: final analysis of the randomized UNICANCER ACCORD 03 trial. J Clin Oncol. 2012;30(16):1941-8. PubMedDOI
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  26. Silverberg MJ, Lau B, Justice AC, Engels E, Gill MJ, Goedert JJ, et al. Risk of anal cancer in HIV-infected and HIV-uninfected individuals in North America. Clin Infect Dis. 2012;54(7):1026-34. PubMedDOI
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  27. Gunderson LL, Moughan J, Ajani JA, Pedersen JE, Winter KA, Benson AB 3rd, et al. Anal carcinoma: impact of TN category of disease on survival, disease relapse, and colostomy failure in US Gastrointestinal Intergroup RTOG 98-11 phase 3 trial. Int J Radiat Oncol Biol Phys. 2013;87(4):638-45. PubMedDOI
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  28. James RD, Glynne-Jones R, Meadows HM, Cunningham D, Myint AS, Saunders MP, et al. Mitomycin or cisplatin chemoradiation with or without maintenance chemotherapy for treatment of squamous-cell carcinoma of the anus (ACT II): a randomised, phase 3, open-label, 2 × 2 factorial trial. Lancet Oncol. 2013;14(6):516-24. PubMedDOI
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  29. Kachnic LA, Winter K, Myerson RJ, Goodyear MD, Willins J, Esthappan J, et al. RTOG 0529: a phase 2 evaluation of dose-painted intensity modulated radiation therapy in combination with 5-fluorouracil and mitomycin-C for the reduction of acute morbidity in carcinoma of the anal canal. Int J Radiat Oncol Biol Phys. 2013;86(1):27-33. PubMedDOI
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  30. Glynne-Jones R, Kadalayil L, Meadows HM, Cunningham D, Samuel L, Geh JI, et al. Tumour- and treatment-related colostomy rates following mitomycin C or cisplatin chemoradiation with or without maintenance chemotherapy in squamous cell carcinoma of the anus in the ACT II trial. Ann Oncol. 2014;25(8):1616-22. PubMedDOI
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  31. Morris VK, Salem ME, Nimeiri H, Iqbal S, Singh P, Ciombor K, et al. Nivolumab for previously treated unresectable metastatic anal cancer (NCI9673): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2017;18(4):446-453. PubMedDOI
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  32. Ott PA, Piha-Paul SA, Munster P, Pishvaian MJ, van Brummelen EMJ, Cohen RB, et al. Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with recurrent carcinoma of the anal canal. Ann Oncol. 2017;28(5):1036-1041. PubMedDOI
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  33. Hagemans JAW, Blinde SE, Nuyttens JJ, Morshuis WG, Mureau MAM, Rothbarth J, et al. Salvage Abdominoperineal Resection for Squamous Cell Anal Cancer: A 30-Year Single-Institution Experience. Ann Surg Oncol. 2018;25(7):1970-1979. PubMedDOI
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  34. Kim S, François E, André T, Samalin E, Jary M, El Hajbi F, et al. Docetaxel, cisplatin, and fluorouracil chemotherapy for metastatic or unresectable locally recurrent anal squamous cell carcinoma (Epitopes-HPV02): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2018;19(8):1094-1106. PubMedDOI
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  35. Goldstone SE, Lensing SY, Stier EA, Darragh T, Lee JY, van Zante A, et al. A Randomized Clinical Trial of Infrared Coagulation Ablation Versus Active Monitoring of Intra-anal High-grade Dysplasia in Adults With Human Immunodeficiency Virus Infection: An AIDS Malignancy Consortium Trial. Clin Infect Dis. 2019;68(7):1204-1212. PubMedDOI
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  36. Ko G, Sarkaria A, Merchant SJ, Booth CM, Patel SV. A systematic review of outcomes after salvage abdominoperineal resection for persistent or recurrent anal squamous cell cancer. Colorectal Dis. 2019;21(6):632-650. PubMedDOI
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  37. Rao S, Sclafani F, Eng C, Adams RA, Guren MG, Sebag-Montefiore D, et al. International Rare Cancers Initiative Multicenter Randomized Phase II Trial of Cisplatin and Fluorouracil Versus Carboplatin and Paclitaxel in Advanced Anal Cancer: InterAAct. J Clin Oncol. 2020;38(22):2510-2518. PubMedDOI
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  38. U.S. Food and Drug Administration, CDER. Oncologic Drugs Advisory Committee meeting, June 24, 2021: draft questions, BLA 761209, retifanlimab, Incyte Corporation. Source
  39. Rao S, Guren MG, Khan K, Brown G, Renehan AG, Steigen SE, et al. Anal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up(☆). Ann Oncol. 2021;32(9):1087-1100. PubMedDOI
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  40. Goldstone SE, Giuliano AR, Palefsky JM, Lazcano-Ponce E, Penny ME, Cabello RE, et al. Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2022;22(3):413-425. PubMedDOI
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  41. Kachnic LA, Winter KA, Myerson RJ, Goodyear MD, Abitbol AA, Streeter OE, et al. Long-Term Outcomes of NRG Oncology/RTOG 0529: A Phase 2 Evaluation of Dose-Painted Intensity Modulated Radiation Therapy in Combination With 5-Fluorouracil and Mitomycin-C for the Reduction of Acute Morbidity in Anal Canal Cancer. Int J Radiat Oncol Biol Phys. 2022;112(1):146-157. PubMedDOI
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  42. Marabelle A, Cassier PA, Fakih M, Kao S, Nielsen D, Italiano A, et al. Pembrolizumab for previously treated advanced anal squamous cell carcinoma: results from the non-randomised, multicohort, multicentre, phase 2 KEYNOTE-158 study. Lancet Gastroenterol Hepatol. 2022;7(5):446-454. PubMedDOI
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  43. Palefsky JM, Lee JY, Jay N, Goldstone SE, Darragh TM, Dunlevy HA, et al. Treatment of Anal High-Grade Squamous Intraepithelial Lesions to Prevent Anal Cancer. N Engl J Med. 2022;386(24):2273-2282. PubMedDOI
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  44. Rao S, Anandappa G, Capdevila J, Dahan L, Evesque L, Kim S, et al. A phase II study of retifanlimab (INCMGA00012) in patients with squamous carcinoma of the anal canal who have progressed following platinum-based chemotherapy (POD1UM-202). ESMO Open. 2022;7(4):100529. PubMedDOI
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  45. Deshmukh AA, Lin YY, Damgacioglu H, Shiels M, Coburn SB, Lang R, et al. Recent and projected incidence trends and risk of anal cancer among people with HIV in North America. J Natl Cancer Inst. 2024;116(9):1450-1458. PubMedDOI
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  46. Stier EA, Clarke MA, Deshmukh AA, Wentzensen N, Liu Y, Poynten IM, et al. International Anal Neoplasia Society's consensus guidelines for anal cancer screening. Int J Cancer. 2024;154(10):1694-1702. PubMedDOI
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  47. U.S. Food and Drug Administration. Prescribing information, Zynyz (retifanlimab-dlwr) injection, revised 5/2025, as approved with BLA 761334/S-004 (Reference ID 5591014). Source
  48. U.S. Food and Drug Administration, CDER. Supplement approval letter, BLA 761334/S-004, Zynyz (retifanlimab-dlwr), Incyte Corporation. e-signed 15 May 2025 (Reference ID 5591014). Source
  49. Feng M, Hallemeier CL, Almada C, Aranha O, Dorth J, Felder S, et al. Radiation Therapy for Anal Squamous Cell Carcinoma: An ASTRO Clinical Practice Guideline. Pract Radiat Oncol. 2025;15(4):367-386. PubMedDOI
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  50. Frood R, Gilbert A, Gilbert D, Abbott NL, Richman SD, Goh V, et al. Personalising anal cancer radiotherapy dose (PLATO): protocol for a multicentre integrated platform trial. BMJ Open. 2025;15(11):e109655. PubMedDOI
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  51. Gilbert A, Adams R, Webster J, Gilbert DC, Abbott NL, Berkman L, et al. Standard versus reduced-dose chemoradiotherapy in anal cancer (PLATO-ACT4): short-term results of a phase 2 randomised controlled trial. Lancet Oncol. 2025;26(6):707-718. PubMedDOI
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  52. National Cancer Institute. Anal Cancer Treatment (PDQ), Health Professional Version. Bethesda (MD): National Cancer Institute; the page shows its latest update as 12 February 2025. Treatment-option sections for stage 0, stages I to III, stage IV and recurrent disease read from the page HTML on 22 October 2026. The summary states that it does not provide formal guidelines or recommendations. Source
  53. National Cancer Institute. Anal Cancer Treatment (PDQ), Health Professional Version. Bethesda (MD): National Cancer Institute; page shows 'Updated: February 12, 2025' (HTTP Last-Modified 20 October 2026). Accessed 22 October 2026. Its staging section reprints, with permission, the TNM tables of the AJCC Cancer Staging Manual, 8th ed. (Springer, 2017, 'Anus', pp. 275-84); the manual itself was not read. Source
  54. Rao S, Samalin-Scalzi E, Evesque L, Ben Abdelghani M, Morano F, Roy A, et al. Retifanlimab with carboplatin and paclitaxel for locally recurrent or metastatic squamous cell carcinoma of the anal canal (POD1UM-303/InterAACT-2): a global, phase 3 randomised controlled trial. Lancet. 2025;405(10495):2144-2152. PubMedDOI
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  55. Troester A, Parikh R, Southwell B, Ester E, Sultan S, Greeno E, et al. Treatment of stage I-III squamous cell anal cancer: a comparative effectiveness systematic review. J Natl Cancer Inst. 2025;117(2):240-252. PubMedDOI
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  56. Belfort GR, Pompeu BF, Velucci MP, Baptista CH, Delgado LM, Marques FILCB, et al. Salvage abdominoperineal resection for anal squamous cell carcinoma: A systematic review and meta-analysis of proportions. Colorectal Dis. 2026;28(7):e70543. PubMedDOI
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  57. ClinicalTrials.gov. NCT00090285 (V501-020). Registry record, API v2, accessed 22 October 2026. NCT00090285
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  71. U.S. Food and Drug Administration. Prescribing information, Zynyz (retifanlimab-dlwr) injection, revised 05/2026, as approved with BLA 761334/S-009 (Reference ID 5799860). Source
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  74. Gandhy SU, Casak SJ, Saung MT, Mishra-Kalyani PS, Tang S, Auth D, et al. FDA Approval Summary: Retifanlimab for the Treatment of Adult Patients with Metastatic or Inoperable Locally Recurrent Squamous Cell Carcinoma of the Anal Canal. Clin Cancer Res. 2026;32(20):4514-4518. PubMedDOI
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  75. Glynne-Jones R, Mawdsley S. The historical perspective on anal cancer therapy: what have we learnt, where did we fail?. ESMO Gastrointest Oncol. 2026;13(Pt A):100151. PubMedDOI
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  76. Morris VK, Ciombor KK, Xiao L, Ochieng JK, Marmonti E, Polite B, et al. NCI9673 (Part B): ETCTN Randomized Phase II Study of Nivolumab With or Without Ipilimumab in Refractory, Metastatic Squamous Cell Carcinoma of the Anal Canal. J Clin Oncol. 2026;44(6):497-507. PubMedDOI
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  77. Rao S, Samalin-Scalzi E, Evesque L, Ben Abdelghani M, Morano F, Roy A, et al. Survival outcomes in POD1UM-303/InterAACT-2: a phase III study of retifanlimab plus carboplatin-paclitaxel in first-line advanced squamous anal cancer. Ann Oncol. 2026;37(8):1157-1166. PubMedDOI
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  78. National Cancer Institute, Surveillance, Epidemiology, and End Results Program. SEER Cancer Stat Facts: Anal Cancer. Page accessed 22 October 2026; the page displays no update date (its HTTP Last-Modified header and last_modified meta tag read 22 April 2026). Source