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Sekundärprophylaxe – HPV-Impfung nach Konisation Elmar A. Joura Medical University – Comprehensive Cancer Center Vienna, Austria Obergurgl, 4 Februar 2013.

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Präsentation zum Thema: "Sekundärprophylaxe – HPV-Impfung nach Konisation Elmar A. Joura Medical University – Comprehensive Cancer Center Vienna, Austria Obergurgl, 4 Februar 2013."—  Präsentation transkript:

1 Sekundärprophylaxe – HPV-Impfung nach Konisation Elmar A. Joura Medical University – Comprehensive Cancer Center Vienna, Austria Obergurgl, 4 Februar 2013

2 Outline Wirkt die HPV-Impfung nur bei jungen Mädchen? Konisation und Frühgeburtlichkeit Konisation und Krebsrisiko HPV- Impfung bei Erkrankten

3 Prophylactic efficacy against HPV 6,11,16,18- related CIN Vaccine (N = 8,799) Placebo (N = 8,800) n Number of cases Rate*n Number of cases Rate* Observed efficacy 95% CI All HPV-Related CIN (64.8, 96.8) By Lesion Type CIN (57.5, 96.2) CIN (30.5, 100.0) CIN 3/AIS (14.9, 100.0) Subjects are counted once in each applicable endpoint category. A subject may appear in more than one category. *Cases per 100 person years at risk. N = Number of subjects randomized to the respective vaccination group who received at least 1 injection and were seronegative and PCR negative to the relevant HPV type at enrollment; n = Number of subjects in the given population with at least 1 follow-up visit following 30 days after Day 1; CIN = cervical intraepithelial neoplasia. Subjects Previously Exposed to 1 Vaccine HPV Type at Day 1 HPV-Related CIN

4 Wirksamkeit nach HPV- Infektionen Seropositive Frauen VaccinePlacebo CINnCasesRatenCasesRate Efficacy (%) 95% CI HPV 6/11/16/181, , (28.7, 100.0) VaccinePlacebo GW+VINnCasesRatenCasesRateEfficacy (%) 95% CI HPV 6/11/16/181, , % (39.5, 100.0) Olsson SE, Vaccine 2009

5 Prophylaktische Wirksamkeit Frauen 24-45a Age GardasilPlacebo % Reduction 95% CIP-value CasespyrCasespyr All Subjects 42,721412,65491%74 – 98< to 34 Year-Olds 21,329241,30192% < to 45 Year-Olds 21,393171,35389% <0.001 PYR = person years at risk; CI = confidence interval. Persistant Infection or clinical endpoint related to HPV 6/11/16/18 Per-protocol analysis Munoz et al, Lancet 2009

6 In situ Carcinome Österreich 6400 Konisationen 30a Gebäralter Frühgeburtsrisiko! Lancet 2006 <50a >50a

7 Meta-analysis of relative risk of perinatal mortality associated with excisional treatment for cervical intraepithelial neoplasia Arbyn M et al. BMJ 2008;337:bmj.a1284 ©2008 by British Medical Journal Publishing Group

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9 Melnikow J et al. JNCI J Natl Cancer Inst 2009;101: Cumulative rates of invasive cervical cancer after CIN

10 Edgren G et al, Lancet Oncology 2007 Vaginal cancer Vulvar cancer Incidence of vaginal and vulvar cancers after CIN 3

11 Edgren G et al, Lancet Oncology 2007 Incidence of anal cancers after CIN 3

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13 Fig 1 Study design for assessing effect of quadrivalent HPV vaccine on incidence of subsequent HPV related disease among women who had undergone surgery for cervical disease or who were diagnosed with vulvar or vaginal disease. Joura E A et al. BMJ 2012;344:bmj.e1401 ©2012 by British Medical Journal Publishing Group

14 Fig 2 Participant flow through study. Joura E A et al. BMJ 2012;344:bmj.e1401 ©2012 by British Medical Journal Publishing Group

15 Fig 3 Incidence of HPV related disease detected 60 days after cervical surgery or diagnosis of vulvar or vaginal disease among women who did not receive quadrivalent HPV vaccine (that is, placebo recipients). Joura E A et al. BMJ 2012;344:bmj.e1401 ©2012 by British Medical Journal Publishing Group

16 Fig 4 Time to detection of any HPV related disease (A) or vulvar or vaginal disease (B) after cervical surgery; and of any HPV related disease (C) or any cervical disease (D) after diagnosis of vulvar or vaginal disease. Joura E A et al. BMJ 2012;344:bmj.e1401 ©2012 by British Medical Journal Publishing Group

17 GARDASIL: FUTURE I/II End-of-Study Results Incidence of HPV Disease After a Cervical Excisional Procedure 1 a Irrespective of HPV type. CI = confidence interval; CIN = cervical intraepithelial neoplasia; GW = genital warts; VaIN = vaginal intraepithelial neoplasia; VIN = vulvar intraepithelial neoplasia. 1. BMJ 2012, Elmar A Joura&al for the Future I and II Study group % a 65% a Percent Reduction (95% CI) (22, 63) (20, 86) 47% a (3.5, 71) 79% (49, 93)

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19 Cervarix post treatment Konisation nach Impfung 190 Cervarix 264 Plazebo 1 vs 9 CIN 2+ VE 88% ( ) 12 vs 22 CIN 1+ VE 42.6% (-21 – 74) Garland SM, Eurogin 2011, Lissabon

20 Swedish K A et al. Clin Infect Dis. 2012;cid.cir1036 Time to recurrence of high-grade AIN among vaccinated and unvaccinated oncogenic HPV–infected MSM with a history of high-grade AIN (n = 105)

21 Was ist der biologische Hintergrund dieser klinischen Wirksamkeit? Schutz gegen anderen HPV- Typ 1 Anamnestischer Response in seropositiven Frauen Impfung verhindert Neuinfektion/ Reaktivierung 2,3 Kreuzprotektion: 32.5% (95%CI: 6.0, 51.9) 4 Kein therapeutischer Effekt! 1) J Infect Dis 2007; 196: ; 2) Vaccine 2007; 25: ; 3) Human Vaccines 2009; 5: ; 4) J Infect Dis 2009; 199:

22 Conclusion Patienten mit HPV- assoziierten Erkrankungen haben ein erhöhtes Risiko für weitere Erkrankungen Frauen nach Konisation haben ein erhöhtes Karzinomrisiko HPV- Impfung senkt das Risiko für weitere Erkrankung signifikant HPV impfung senkt das Risiko für weitere Konisation um 65-88% Impfung kann schon vor der Behandlung begonnen werden!


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