Clinical trial NCT02437851 - References

HIV Infection — Surgery in Treating Patients With Early Stage Anal Canal or Perianal Cancer and HIV Infection

Citation(s)

•   Beahrs OH, Wilson SM
  Carcinoma of the anus. Ann Surg. 1976 Oct;184(4):422-8. doi: 10.1097/00000658-197610000-00004.
•   Benson AB, Venook AP, Al-Hawary MM, Cederquist L, Chen YJ, Ciombor KK, Cohen S, Cooper HS, Deming D, Engstrom PF, Garrido-Laguna I, Grem JL, Grothey A, Hochster HS, Hoffe S, Hunt S, Kamel A, Kirilcuk N, Krishnamurthi S, Messersmith WA, Meyerhardt J, Miller ED, Mulcahy MF, Murphy JD, Nurkin S, Saltz L, Sharma S, Shibata D, Skibber JM, Sofocleous CT, Stoffel EM, Stotsky-Himelfarb E, Willett CG, Wuthrick E, Gregory KM, Freedman-Cass DA
  NCCN Guidelines Insights: Colon Cancer, Version 2.2018. J Natl Compr Canc Netw. 2018 Apr;16(4):359-369. doi: 10.6004/jnccn.2018.0021.
•   Brodman M, Dottino P, Friedman F Jr, Heller D, Bleiweiss I, Sperling R
  Human papillomavirus-associated lesions of the vagina and cervix. Treatment with a laser and topical 5-fluorouracil. J Reprod Med. 1992 May;37(5):453-6.
•   Chai CY, Tran Cao HS, Awad S, Massarweh NN
  Management of Stage I Squamous Cell Carcinoma of the Anal Canal. JAMA Surg. 2018 Mar 1;153(3):209-215. doi: 10.1001/jamasurg.2017.3151. Erratum In: JAMA Surg. 2018 May 23;153(7):692.
•   Chang GJ, Berry JM, Jay N, Palefsky JM, Welton ML
  Surgical treatment of high-grade anal squamous intraepithelial lesions: a prospective study. Dis Colon Rectum. 2002 Apr;45(4):453-8. doi: 10.1007/s10350-004-6219-8.
•   Da Costa MM, Hogeboom CJ, Holly EA, Palefsky JM
  Increased risk of high-grade anal neoplasia associated with a human papillomavirus type 16 E6 sequence variant. J Infect Dis. 2002 May 1;185(9):1229-37. doi: 10.1086/340125. Epub 2002 Apr 16.
•   Darragh TM, Colgan TJ, Cox JT, Heller DS, Henry MR, Luff RD, McCalmont T, Nayar R, Palefsky JM, Stoler MH, Wilkinson EJ, Zaino RJ, Wilbur DC; Members of LAST Project Work Groups
  The Lower Anogenital Squamous Terminology Standardization Project for HPV-Associated Lesions: background and consensus recommendations from the College of American Pathologists and the American Society for Colposcopy and Cervical Pathology. J Low Genit Tract Dis. 2012 Jul;16(3):205-42. doi: 10.1097/LGT.0b013e31825c31dd. Erratum In: J Low Genit Tract Dis. 2013 Jul;17(3):368.
•   de Sanjose S, Quint WG, Alemany L, Geraets DT, Klaustermeier JE, Lloveras B, Tous S, Felix A, Bravo LE, Shin HR, Vallejos CS, de Ruiz PA, Lima MA, Guimera N, Clavero O, Alejo M, Llombart-Bosch A, Cheng-Yang C, Tatti SA, Kasamatsu E, Iljazovic E, Odida M, Prado R, Seoud M, Grce M, Usubutun A, Jain A, Suarez GA, Lombardi LE, Banjo A, Menendez C, Domingo EJ, Velasco J, Nessa A, Chichareon SC, Qiao YL, Lerma E, Garland SM, Sasagawa T, Ferrera A, Hammouda D, Mariani L, Pelayo A, Steiner I, Oliva E, Meijer CJ, Al-Jassar WF, Cruz E, Wright TC, Puras A, Llave CL, Tzardi M, Agorastos T, Garcia-Barriola V, Clavel C, Ordi J, Andujar M, Castellsague X, Sanchez GI, Nowakowski AM, Bornstein J, Munoz N, Bosch FX; Retrospective International Survey and HPV Time Trends Study Group
  Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol. 2010 Nov;11(11):1048-56. doi: 10.1016/S1470-2045(10)70230-8. Epub 2010 Oct 15.
•   Deshmukh AA, Suk R, Shiels MS, Sonawane K, Nyitray AG, Liu Y, Gaisa MM, Palefsky JM, Sigel K
  Recent Trends in Squamous Cell Carcinoma of the Anus Incidence and Mortality in the United States, 2001-2015. J Natl Cancer Inst. 2020 Aug 1;112(8):829-838. doi: 10.1093/jnci/djz219.
•   FALKSON G, SCHULZ EJ
  Skin changes in patients treated with 5-fluorouracil. Br J Dermatol. 1962 Jun;74:229-36. doi: 10.1111/j.1365-2133.1962.tb13497.x. No abstract available.
•   Fox PA, Nathan M, Francis N, Singh N, Weir J, Dixon G, Barton SE, Bower M
  A double-blind, randomized controlled trial of the use of imiquimod cream for the treatment of anal canal high-grade anal intraepithelial neoplasia in HIV-positive MSM on HAART, with long-term follow-up data including the use of open-label imiquimod. AIDS. 2010 Sep 24;24(15):2331-5. doi: 10.1097/QAD.0b013e32833d466c.
•   Fuchshuber PR, Rodriguez-Bigas M, Weber T, Petrelli NJ
  Anal canal and perianal epidermoid cancers. J Am Coll Surg. 1997 Nov;185(5):494-505. doi: 10.1016/s1072-7515(97)00094-x. Erratum In: J Am Coll Surg 1998 Jan;186(1):112.
•   Gagne SE, Jensen R, Polvi A, Da Costa M, Ginzinger D, Efird JT, Holly EA, Darragh T, Palefsky JM
  High-resolution analysis of genomic alterations and human papillomavirus integration in anal intraepithelial neoplasia. J Acquir Immune Defic Syndr. 2005 Oct 1;40(2):182-9. doi: 10.1097/01.qai.0000179460.61987.33.
•   Goldstone RN, Goldstone AB, Russ J, Goldstone SE
  Long-term follow-up of infrared coagulator ablation of anal high-grade dysplasia in men who have sex with men. Dis Colon Rectum. 2011 Oct;54(10):1284-92. doi: 10.1097/DCR.0b013e318227833e.
•   Goldstone SE, Hundert JS, Huyett JW
  Infrared coagulator ablation of high-grade anal squamous intraepithelial lesions in HIV-negative males who have sex with males. Dis Colon Rectum. 2007 May;50(5):565-75. doi: 10.1007/s10350-006-0874-x.
•   Goldstone SE, Johnstone AA, Moshier EL
  Long-term outcome of ablation of anal high-grade squamous intraepithelial lesions: recurrence and incidence of cancer. Dis Colon Rectum. 2014 Mar;57(3):316-23. doi: 10.1097/DCR.0000000000000058.
•   Graham BD, Jetmore AB, Foote JE, Arnold LK
  Topical 5-fluorouracil in the management of extensive anal Bowen's disease: a preferred approach. Dis Colon Rectum. 2005 Mar;48(3):444-50. doi: 10.1007/s10350-004-0901-8.
•   Heselmeyer K, du Manoir S, Blegen H, Friberg B, Svensson C, Schrock E, Veldman T, Shah K, Auer G, Ried T
  A recurrent pattern of chromosomal aberrations and immunophenotypic appearance defines anal squamous cell carcinomas. Br J Cancer. 1997;76(10):1271-8. doi: 10.1038/bjc.1997.547.
•   Heselmeyer K, Macville M, Schrock E, Blegen H, Hellstrom AC, Shah K, Auer G, Ried T
  Advanced-stage cervical carcinomas are defined by a recurrent pattern of chromosomal aberrations revealing high genetic instability and a consistent gain of chromosome arm 3q. Genes Chromosomes Cancer. 1997 Aug;19(4):233-40.
•   Heselmeyer K, Schrock E, du Manoir S, Blegen H, Shah K, Steinbeck R, Auer G, Ried T
  Gain of chromosome 3q defines the transition from severe dysplasia to invasive carcinoma of the uterine cervix. Proc Natl Acad Sci U S A. 1996 Jan 9;93(1):479-84. doi: 10.1073/pnas.93.1.479.
•   Klas JV, Rothenberger DA, Wong WD, Madoff RD
  Malignant tumors of the anal canal: the spectrum of disease, treatment, and outcomes. Cancer. 1999 Apr 15;85(8):1686-93. doi: 10.1002/(sici)1097-0142(19990415)85:83.0.co;2-7.
•   Kreuter A, Hochdorfer B, Stucker M, Altmeyer P, Weiland U, Conant MA, Brockmeyer NH
  Treatment of anal intraepithelial neoplasia in patients with acquired HIV with imiquimod 5% cream. J Am Acad Dermatol. 2004 Jun;50(6):980-1. doi: 10.1016/j.jaad.2003.12.025. No abstract available.
•   Kreuter A, Potthoff A, Brockmeyer NH, Gambichler T, Stucker M, Altmeyer P, Swoboda J, Pfister H, Wieland U; German Competence Network HIV/AIDS
  Imiquimod leads to a decrease of human papillomavirus DNA and to a sustained clearance of anal intraepithelial neoplasia in HIV-infected men. J Invest Dermatol. 2008 Aug;128(8):2078-83. doi: 10.1038/jid.2008.24. Epub 2008 Feb 14.
•   Leonard D, Beddy D, Dozois EJ
  Neoplasms of anal canal and perianal skin. Clin Colon Rectal Surg. 2011 Mar;24(1):54-63. doi: 10.1055/s-0031-1272824.
•   Mahto M, Nathan M, O'Mahony C
  More than a decade on: review of the use of imiquimod in lower anogenital intraepithelial neoplasia. Int J STD AIDS. 2010 Jan;21(1):8-16. doi: 10.1258/ijsa.2009.009309.
•   Maiman M, Watts DH, Andersen J, Clax P, Merino M, Kendall MA
  Vaginal 5-fluorouracil for high-grade cervical dysplasia in human immunodeficiency virus infection: a randomized trial. Obstet Gynecol. 1999 Dec;94(6):954-61. doi: 10.1016/s0029-7844(99)00407-x.
•   Marks DK, Goldstone SE
  Electrocautery ablation of high-grade anal squamous intraepithelial lesions in HIV-negative and HIV-positive men who have sex with men. J Acquir Immune Defic Syndr. 2012 Mar 1;59(3):259-65. doi: 10.1097/QAI.0b013e3182437469.
•   Mathiesen O, Buus SK, Cramers M
  Topical imiquimod can reverse vulvar intraepithelial neoplasia: a randomised, double-blinded study. Gynecol Oncol. 2007 Nov;107(2):219-22. doi: 10.1016/j.ygyno.2007.06.003. Epub 2007 Jul 25.
•   Meyerson M, Gabriel S, Getz G
  Advances in understanding cancer genomes through second-generation sequencing. Nat Rev Genet. 2010 Oct;11(10):685-96. doi: 10.1038/nrg2841.
•   Mine KL, Shulzhenko N, Yambartsev A, Rochman M, Sanson GF, Lando M, Varma S, Skinner J, Volfovsky N, Deng T, Brenna SM, Carvalho CR, Ribalta JC, Bustin M, Matzinger P, Silva ID, Lyng H, Gerbase-DeLima M, Morgun A
  Gene network reconstruction reveals cell cycle and antiviral genes as major drivers of cervical cancer. Nat Commun. 2013;4:1806. doi: 10.1038/ncomms2693.
•   Oehler-Janne C, Huguet F, Provencher S, Seifert B, Negretti L, Riener MO, Bonet M, Allal AS, Ciernik IF
  HIV-specific differences in outcome of squamous cell carcinoma of the anal canal: a multicentric cohort study of HIV-positive patients receiving highly active antiretroviral therapy. J Clin Oncol. 2008 May 20;26(15):2550-7. doi: 10.1200/JCO.2007.15.2348. Epub 2008 Apr 21.
•   Ortholan C, Ramaioli A, Peiffert D, Lusinchi A, Romestaing P, Chauveinc L, Touboul E, Peignaux K, Bruna A, de La Roche G, Lagrange JL, Alzieu C, Gerard JP
  Anal canal carcinoma: early-stage tumors < or =10 mm (T1 or Tis): therapeutic options and original pattern of local failure after radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Jun 1;62(2):479-85. doi: 10.1016/j.ijrobp.2004.09.060.
•   Ortholan C, Resbeut M, Hannoun-Levi JM, Teissier E, Gerard JP, Ronchin P, Zaccariotto A, Minsat M, Benezery K, Francois E, Salem N, Ellis S, Azria D, Champetier C, Gross E, Cowen D
  Anal canal cancer: management of inguinal nodes and benefit of prophylactic inguinal irradiation (CORS-03 Study). Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1988-95. doi: 10.1016/j.ijrobp.2011.02.010. Epub 2011 May 11.
•   Pineda CE, Berry JM, Jay N, Palefsky JM, Welton ML
  High-resolution anoscopy targeted surgical destruction of anal high-grade squamous intraepithelial lesions: a ten-year experience. Dis Colon Rectum. 2008 Jun;51(6):829-35; discussion 835-7. doi: 10.1007/s10350-008-9233-4. Epub 2008 Mar 25.
•   Poluri RM, Higgins SP
  Successful treatment of penile Bowen's disease with 5% imiquimod cream. Int J STD AIDS. 2005 Sep;16(9):649. doi: 10.1258/0956462054944444. No abstract available.
•   Ramoni S, Cusini M, Gaiani F, Arancio L, Alessi E
  Penile intraepithelial carcinoma treated with imiquimod 1% in an HIV-positive patient. J Dermatolog Treat. 2009;20(3):177-8. doi: 10.1080/09546630802562435. No abstract available.
•   Richel O, de Vries HJ, van Noesel CJ, Dijkgraaf MG, Prins JM
  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. Lancet Oncol. 2013 Apr;14(4):346-53. doi: 10.1016/S1470-2045(13)70067-6. Epub 2013 Mar 15.
•   Richel O, Wieland U, de Vries HJ, Brockmeyer NH, van Noesel C, Potthoff A, Prins JM, Kreuter A
  Topical 5-fluorouracil treatment of anal intraepithelial neoplasia in human immunodeficiency virus-positive men. Br J Dermatol. 2010 Dec;163(6):1301-7. doi: 10.1111/j.1365-2133.2010.09982.x. Epub 2010 Nov 4.
•   Schlecht NF, Burk RD, Palefsky JM, Minkoff H, Xue X, Massad LS, Bacon M, Levine AM, Anastos K, Gange SJ, Watts DH, Costa MMD, Chen Z, Bang JY, Fazzari M, Hall C, Strickler HD
  Variants of human papillomaviruses 16 and 18 and their natural history in human immunodeficiency virus-positive women. J Gen Virol. 2005 Oct;86(Pt 10):2709-2720. doi: 10.1099/vir.0.81060-0.
•   Schmitz M, Driesch C, Jansen L, Runnebaum IB, Durst M
  Non-random integration of the HPV genome in cervical cancer. PLoS One. 2012;7(6):e39632. doi: 10.1371/journal.pone.0039632. Epub 2012 Jun 27.
•   Schwarz JK, Payton JE, Rashmi R, Xiang T, Jia Y, Huettner P, Rogers BE, Yang Q, Watson M, Rader JS, Grigsby PW
  Pathway-specific analysis of gene expression data identifies the PI3K/Akt pathway as a novel therapeutic target in cervical cancer. Clin Cancer Res. 2012 Mar 1;18(5):1464-71. doi: 10.1158/1078-0432.CCR-11-2485. Epub 2012 Jan 10.
•   Shiels MS, Pfeiffer RM, Chaturvedi AK, Kreimer AR, Engels EA
  Impact of the HIV epidemic on the incidence rates of anal cancer in the United States. J Natl Cancer Inst. 2012 Oct 17;104(20):1591-8. doi: 10.1093/jnci/djs371. Epub 2012 Oct 5.
•   Steele SR, Varma MG, Melton GB, Ross HM, Rafferty JF, Buie WD; Standards Practice Task Force of the American Society of Colon and Rectal Surgeons
  Practice parameters for anal squamous neoplasms. Dis Colon Rectum. 2012 Jul;55(7):735-49. doi: 10.1097/DCR.0b013e318255815e. No abstract available.
•   Stier EA, Goldstone SE, Berry JM, Panther LA, Jay N, Krown SE, Lee J, Palefsky JM
  Infrared coagulator treatment of high-grade anal dysplasia in HIV-infected individuals: an AIDS malignancy consortium pilot study. J Acquir Immune Defic Syndr. 2008 Jan 1;47(1):56-61. doi: 10.1097/QAI.0b013e3181582d93.
•   van Seters M, van Beurden M, de Craen AJ
  Is the assumed natural history of vulvar intraepithelial neoplasia III based on enough evidence? A systematic review of 3322 published patients. Gynecol Oncol. 2005 May;97(2):645-51. doi: 10.1016/j.ygyno.2005.02.012.
•   Wagstaff AJ, Perry CM
  Topical imiquimod: a review of its use in the management of anogenital warts, actinic keratoses, basal cell carcinoma and other skin lesions. Drugs. 2007;67(15):2187-210. doi: 10.2165/00003495-200767150-00006.
•   Wexler A, Berson AM, Goldstone SE, Waltzman R, Penzer J, Maisonet OG, McDermott B, Rescigno J
  Invasive anal squamous-cell carcinoma in the HIV-positive patient: outcome in the era of highly active antiretroviral therapy. Dis Colon Rectum. 2008 Jan;51(1):73-81. doi: 10.1007/s10350-007-9154-7. Epub 2007 Dec 8.
•   Wingo SN, Gallardo TD, Akbay EA, Liang MC, Contreras CM, Boren T, Shimamura T, Miller DS, Sharpless NE, Bardeesy N, Kwiatkowski DJ, Schorge JO, Wong KK, Castrillon DH
  Somatic LKB1 mutations promote cervical cancer progression. PLoS One. 2009;4(4):e5137. doi: 10.1371/journal.pone.0005137. Epub 2009 Apr 2.
•   Xi LF, Critchlow CW, Wheeler CM, Koutsky LA, Galloway DA, Kuypers J, Hughes JP, Hawes SE, Surawicz C, Goldbaum G, Holmes KK, Kiviat NB
  Risk of anal carcinoma in situ in relation to human papillomavirus type 16 variants. Cancer Res. 1998 Sep 1;58(17):3839-44.
•   Zilli T, Schick U, Ozsahin M, Gervaz P, Roth AD, Allal AS
  Node-negative T1-T2 anal cancer: radiotherapy alone or concomitant chemoradiotherapy? Radiother Oncol. 2012 Jan;102(1):62-7. doi: 10.1016/j.radonc.2011.09.015. Epub 2011 Oct 10.

A Multicenter Observational and Feasibility Study of Excision of Superficially Invasive Squamous Cell Carcinoma (SISCCA) of the Anal Canal and Perianus in HIV-Infected Persons

Details for clinical trial NCT02437851