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Terapie antiangiogenetiche: revisione e gestione degli eventi avversi

Terapie antiangiogenetiche: revisione e gestione degli eventi avversi. Lucia Del Mastro SS Sviluppo Terapie Innovative Modena- 18 Novembre 2011. IRCCS Azienda Ospedaliera Universitaria San Martino – IST Istituto Nazionale per la Ricerca sul Cancro. Fatal adverse event

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Terapie antiangiogenetiche: revisione e gestione degli eventi avversi

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  1. Terapie antiangiogenetiche: revisione e gestione degli eventi avversi Lucia Del Mastro SS Sviluppo Terapie Innovative Modena- 18 Novembre 2011 IRCCS Azienda Ospedaliera Universitaria San Martino – IST Istituto Nazionale per la Ricerca sul Cancro

  2. Fatal adverse event • Death caused in all likelihhod by a drug -> major cause of fatality in USA • 0.3% in prespective studies • 4.6% of all hospital fatality

  3. CAIRO study tested the optimal use of well-established cyctotoxic (capecitabine, irinoteca, oxaliplatin) • 820 enrolled patients • 112 deaths (14%) occurring within 30 days of last administration of study drug • 72 (9%) deaths caused by PD • 40 (5%) deaths without PD

  4. Relationship between cause of death and study drugs changed in 65% of patients -> underestimation by local investigators of the relation between the administration of study drugs and death

  5. Beva vs contl AVF2119g: 0 events E2100: 0.5% vs 0.3% Avado: 0.8% vs 1.7% RIBBON1: 1.7% vs 2.7% Overall: OR: 0.642 (95% CI 0.334-1.232; p=0.183

  6. ATEs: Beva: 0.93% Cntl: 0.56 OR: 1.49 (0.69-3.19) P=0.3 VTEs: Beva: 2.6% Cntl: 2.6% OR: 1.06 (0.70-1.61) P=0.78

  7. Beva: 4.9% Cntl: 2.8% OR: 1.45 P=0.052 Beva: 0.51% Cntl: 0.21% OR: 1.84 P=0.327

  8. Beva: 9.7% Cntl: 0.64% OR: 12.76 (2.93-55.53) P=0.001 OR: 27.68 P<0.0001

  9. Beva: 1.31% Cntl: 0.28% OR: 4.07 P=0.006

  10. Beva: 1.73% Cntl: 0.78% OR: 2.25 (1.16-4.37) P=0.017

  11. Beva: 1.6% Cntl: 0.4% RR 4.74 (1.66-11.18) P=0.001

  12. Bevacizumab and osteonecrosis of the jaw • Hypothesis: because healing after mucosal trauma requires re-vascularization, the combination of Beva and a biphosphonate could affect the incidence, the time to development of ONJ and/or the response to dental therapy.

  13. Bevacizumab and osteonecrosis of the jaw • Hoff AO, Ann NY Acad Sci 1218: 47-54; 2011 • Guarneri V Breast Cancer Res Treat 122: 181-188; 2010 • McArthur HL , ASCO 2008; abstr 9588

  14. Bevacizumab and osteonecrosis of the jaw

  15. Meta-analyses evaluating the safety of bevacizumab Cortes, Ann Oncol 2011; Ranpura JAMA 2011; Choueiri JCO 2011

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