1 / 27

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

thora
Download Presentation

Terapie antiangiogenetiche: revisione e gestione degli eventi avversi

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related