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Ресурси - портфолио за рак на маточната шийка

Подобряване на скрининга на рака на маточната шийка, триаж и диагностика с биомаркерна технология от следващо поколение. Фокус върху науката, свързана с HPV доведе до еволюция в стратегиите за скрининг на рак на маточната шийка.


С днешния научен напредък и съвременното разбиране за HPV, вече не вярваме, че статуквото при скрининг на шийката на матката е достатъчно добро. Рош продължава да работи усилено в посока скринингови стратегии, разработване на продукти и доказателства от клинични проучвания, защото знаем, че очаквате това, в подкрепа на жените, които заслужават повече.

Портфолиото на Рош за рак на маточната шийка е уникално с това, че подпомага жените по време на целия континуум на здравната грижа, в подкрепа на усилията на здравните специалисти, касаещи скрининг и диагностициране на заболяването, преди да се развие инвазивен рак. Ние помагаме на лаборатории и клиницисти, като предоставяме допълнителна информация за риска на пациента, за индивидуализиран подход в грижата и базирани на доказателства важни решения за лечение. Осигуряването на подходяща грижа за жената, в точното време, не само ще й помогне и предпази от прогресия на заболяването, но също така може да й помогне и предпази от риск, свързан със свръх- или недостатъчно лечение.




Известни проучвания, които доказват стойността на промяната

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IMPACT Trial


The IMPACT Trial supports the FDA approval of multiple products, including CINtec® PLUS Cytology

Discussing screening options outdoors

ATHENA Trial

Shaping our Understanding of the Role of High-Risk HPV Testing in Cervical Cancer Screening
Tamika Felder personal HPV and cervical cancer story

CERTAIN Study

The (CERvical Tissue AdjunctIve aNalysis) study is one of the largest, most rigorous immunohistochemistry clinical studies.
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Danielle, a NYC based freelance writer for women's health, pop culture and relationships, Author of "The Semi-Scandalous Story of an Ex-Virgin", HPV #cervivor, and huge baseball fan, discusses cervical cancer prevention.

HPV tried to wreck Danielle's life, and took her on a scary journey to prevent cervical abnormalities from progressing into invasive cancer. Watch this video (Part 1 of 4) where Danielle explains the role of HPV and how unfair it is that women feel stigma around something so relatively common. To watch the rest of Danielle's stories, please click here.

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A Clinician's Perspective on New Biomarker Technology to Assess Risk in Cervical Cancer Prevention

Dr. Nathalie Michaud meets with Danielle Sepulveres in San Francisco to give an update about what’s important to know about cervical cancer prevention. During this conversation, they discuss Pap cytology, HPV testing, and a new option to use advanced biomarker technology approved by the FDA in March 2020 for women with positive high-risk HPV screening results. Run from the same sample collected for Pap cytology or HPV testing, next generation biomarker cytology provides additional information that can help guide a clinician’s next step decisions for a patient.

“Whether [the biomarker test result] is positive or negative, you know what to do, and you don’t have to wait and worry” – Dr. Nathalie Michaud.

To view Danielle’s full clinician perspective video story, click here.

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Simplifies screening, triage and diagnosis
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Detects disease earlier
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Ensures certainty of results
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Unifies sample collection for HPV DNA, Pap or CINtec® PLUS Cytology
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Списания и статии

Множество публикувани статии подкрепят напредъка на науката около превенцията на HPV и рака на маточната шийка. Науката, която стои зад HPV и неговата роля при прогресия на заболяването, откри нови пътища за управление на риска и грижата за пациентите. Моля, вижте по-долу резюме на публикации от клинични проучвания, които са били от голямо значение при оформяне на днешното разбиране и насоки в  клиничната практика.

 

HPV скрининг и превенция на цервикален карцином:

  • Simms et al., Impact of scaled up human papillomavirus vaccination and cervical screening and the potential for global elimination of cervical cancer in 181 countries, Lancet Oncology 2020–99: a modelling study, Volume 20, Issue 3, March 2019, Pages 394-407  https://www.sciencedirect.com/science/article/pii/S1470204518308362  (Accessed 1 June 2020)
  • Rijkaart DC, Berkhof J, Rozendaal L, et al. Human papillomavirus testing for the detection for high-grade cervical intraepithelial neoplasia and cancer: final results of the POBASCAM randomized controlled trial. Lancet Oncol. 2012; 13:78-88.
  • Saslow D, Solomon D. Lawson HW, et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. Am J Clin Pathol. 2012; 137:516-542.
  • Cox JT, Castle PE, Behrens CM, et al. Comparison of cervical cancer screening strategies incorporating different combinations of cytology, HPV testing and genotyping for HPV 16/18: results from the ATHENA HPV study. Am J Ob Gyn. 2012:In Press.
  • Castle PE, Stoler MH, Wright TC Jr, Sharma A, Wright TL, Behrens CM. Performance of carcinogenic human papillomavirus (HPV) testing and HPV16 or HPV18 genotyping for cervical cancer screening of women aged 25 years and older: a subanalysis of the ATHENA study [published online August 23, 2011]. Lancet Oncol. doi:10.1016/S1470-2045(11)70188- 7.
  • Whitlock EP, Vesco KK, Eder M, Lin JS, Senger CA, Burda BU. Liquid-based cytology and human papillomavirus testing to screen for cervical cancer: a systematic review for the U.S. Preventative Services Task Force. Ann Intern Med. 2011; 155:687-697.
  • Andrae B, Kemetli L, Sparén P, et al. Screening-preventable cervical cancer risks: evidence from a nationwide audit in Sweden.J Natl Cancer Inst. 2008;100(9):622-629.
  • Herzog TJ, Monk BH. Reducing the burden of glandular carcinomas of the uterine cervix. Am J Obstet Gynecol. 2007;197:566-571.
  • Leyden WA, Manos MM, Geiger AM, et al. Cervical cancer in women with comprehensive health care access: attributable factors in the screening process. J Natl Cancer Inst. 2005;97(9):675-683.
  • Bosch FX, de Sanjosé S. Chapter 1: Human papillomavirus and cervical cancer—burden and assessment of causality. J Natl Cancer Inst Monogr. 2003;31:3-13.

 

p16 / Ki-67 Двойно биомаркер оцветяване при скрининг за цервикален карцином:

  • Wentzensen N., et al.,Clinical Evaluation of Human Papillomavirus Screening With p16/Ki-67 Dual Stain Triage in a Large Organized Cervical Cancer Screening Program JAMA Intern Med. 2019;179(7):881-888. doi:10.1001/jamainternmed.2019.0306. Published online May 13, 2019.
  • Clarke MA, Cheung LC, Castle PE, Schiffman M, Tokugawa D, Poitras N, Lorey T, Kinney W, Wentzensen N. Five-Year Risk of Cervical Precancer Following p16/Ki-67 Dual-Stain Triage of HPV-Positive Women. JAMA Oncol. 2019 Feb 1;5(2):181-186. doi: 10.1001/jamaoncol.2018.4270. PMID: 30325982; PMCID: PMC6439556.
  • T.C. Wright Jr. et al., Triaging HPV-Positive Women with p16/Ki-67 Dual-stained Cytology: Results from a Sub-study Nested into the ATHENA Trial. Gynecol Oncol. 2017 Jan;144(1):51-56. doi: 10.1016/j.ygyno.2016.10.031.
  • KU Petry et al., A model to evaluate the costs and clinical effectiveness of human papilloma virus screening compared with annual papanicolaou cytology in Germany. European Journal of Obstetrics & Gynecology and Reproductive Biology 212 (2017) 132–139.
  • Bergeron, C. et al., Prospective evaluation of p16/Ki-67 dual-stained cytology for managing women with abnormal Papanicolaou cytology: PALMS study results. Cancer Cytopathol. 2015 Jun;123(6):373-81. doi: 10.1002/cncy.21542. Epub 2015 Apr 17.
  • Wentzensen N., et al., p16/Ki-67 Dual Stain Cytology for Detection of Cervical Precancer in HPV-Positive Women. J Natl Cancer Inst. 2015 Sep 15;107(12):djv257. doi: 10.1093/jnci/djv257. Print 2015 Dec.
  • Killeen JL, Dye T, Grace C, Hiraoka M. Improved abnormal Pap smear triage using cervical cancer biomarkers. J Low Genit Tract Dis. 2014;18(1):1-7. DOI:10.1097/LGT.0b013e31828aeb39.
  • Ikenberg, H. et al., Screening for Cervical Cancer Precursors With p16/Ki-67 Dual-Stained Cytology: Results of the PALMS Study. J Natl Cancer Inst. 2013 Oct 16; 105(20): 1550–1557.
  • Wentzensen N., et al., Performance of p16/Ki-67 Immunostaining to Detect Cervical Cancer Precursors in a Colposcopy Referral Population. Clin Cancer Res. 2012 Aug 1;18(15):4154-62. doi: 10.1158/1078-0432.CCR-12-0270. Epub 2012 Jun 6.
  • Waldstrøm, M., et al., Evaluation of p16INK4a/Ki-67 Dual Stain in Comparison With an mRNA Human Papillomavirus Test on Liquid-Based Cytology Samples With Low-Grade Squamous Intraepithelial Lesion. Cancer Cytopathol. 2013 Mar;121(3):136-45. doi: 10.1002/cncy.21233. Epub 2012 Sep 17.
  • Schmidt D, Bergeron C, Denton KJ, Ridder R for the European CINtec Cytology Study Group. p16/Ki-67 dual-stain cytology in the triage of ASCUS and LSIL papanicolaou cytology: results from the European equivocal or mildly abnormal Papanicolaou cytology study. Cancer Cytopathol. 2011;119(3):158-166. doi: 10.1002/cncy.20140. Epub 2011 Mar 25.
  • Petry KU, Schmidt D, Scherbring S, et al. Triaging Pap cytology negative, HPV positive cervical cancer screening results with p16/Ki-67 dual-stained cytology. Gynecol Oncol. 2011;121(3);505-509. doi: 10.1016/j.ygyno.2011.02.033. Epub 2011 Mar 21.

 

p16 Имунохистохимия при оценката на цервикални биопсии:

  • Stoler MH, Wright TC Jr, Ferenczy A, Ranger-Moore J, Fang Q, Kapadia M, Ridder R. Routine Use of Adjunctive p16 Immunohistochemistry Improves Diagnostic Agreement of Cervical Biopsy Interpretation: Results From the CERTAIN Study. Am J Surg Pathol. 2018 Aug;42(8):1001-1009. doi: 10.1097/PAS.0000000000001072. PMID: 29697437.
  • Darragh TM, Colgan TJ, Cox JT, et al. 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;16:205-242. Erratum in J Low Genit Tract Dis. 2013;17:368.
  • Bergeron, C., et al, Conjunctive p16INK4a Testing Significantly Increases Accuracy in Diagnosing High-Grade Cervical Intraepithelial Neoplasia. Am J Clin Pathol 2010;133:395-406. DOI: 10.1309/AJCPXSVCDZ3D5MZM
  • Galgano, M, et al, Using Biomarkers as Objective Standards in the Diagnosis of Cervical Biopsies. Am J Surg Pathol. 2010;34:1077–1087.
  • Ordi, J., et al. p16INK4a Immunostaining Identifies Occult CIN Lesions in HPV-positive Women. International Journal of Gynecological Pathology 2008; 28:90–97. DOI: 10.1097/PGP.0b013e31817e9ac5
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Cervical Cancer Screening

  • When should I be screened for cervical cancer?

  • Could I get an HPV test as part of my exam?

  • If have been vaccinated for HPV, do I still need cervical cancer screening?

  • How often do you recommend I get an HPV test?

  • I want an HPV test that detects HPV 16 and 18, how do I get it?

  • If my results are positive, what is the next step?

  • Are there any brochures, websites or other materials that I can use to learn more about cervical cancer prevention?

General Health

  • Do I need any important shots?

  • How can I protect myself from HIV and other STDs?

  • Where can I get mental health help?

  • How can I get more physical activity?

  • What form of birth control is right for me?

  • How can I incorporate more healthy eating habits into my diet?

  • Given my family history, am I at a higher risk for certain diseases or illnesses?

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Aflați mai multe despre testul CINtec® PLUS Cytology elaborat de Roche și modul în care acesta vă oferă un indicator puternic al prezenței infecțiilor cu HPV transformante.
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Референции:

  1. Screening for Cervical Cancer in Primary Care: A Decision Analysis for the U.S. Preventive Services Task Force. Agency for Healthcare Research and Quality (US) Kim et. al., JAMA. 2018;320:706‐714 http://uspreventiveservicestaskforce.org/uspstf/document/modeling-study/cervical-cancer-screening;
    Accessed 4 August 2020.
  2. Cervical Cancer Screening for Individuals at Average Risk: 2020 Guideline Update from the American Cancer Society, Fontham et. al. https://acsjournals.onlinelibrary.wiley.com/doi/pdfdirect/10.3322/caac.21628; Accessed 3 August 2020
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