Avastin - Abstract 635: Arterial thromboembolic events in a pooled analysis of 5 randomized, controlled trials of bevacizumab with chemotherapy
Citation: European Journal of Cancer Supplements Volume 3, No. 2, October 2005, Page 179
J. Skillings1, D. Johnson2, K. Miller3, F. Kabbinavar4, E. Bergsland5, E. Holmgren1, S.N. Holden1, H. Hurwitz6, F. Scappaticci1
1Genentech, Inc, South San Francisco, CA, USA
2Vanderbilt Cancer Center, Nashville, TN, USA
3Indiana Cancer Pavilion, Indianapolis, IN, USA
4University of California at Los Angeles, Los Angeles, CA, USA
5University of California at San Francisco Cancer Center, San Francisco, CA, USA
6Duke University Medical Center, Durham, NC, USA
Background:
Bevacizumab (AvastinTM) is a monoclonal antibody to VEGF with demonstrated survival benefit when combined with chemotherapy in metastatic colorectal cancer (mCRC).
Individual safety data from several randomized controlled trials suggested that adding bevacizumab to chemotherapy may increase the risk of arterial thromboembolic events.
We conducted a pooled analysis to evaluate this potential safety signal.
Methods:
Data from 1745 pts with metastatic carcinomas (breast, colorectal, and non-small-cell lung) pooled from 5 randomized controlled trials of bevacizumab with chemotherapy were analyzed to assess arterial thromboembolic event risk and identify predisposing factors in the context of overall clinical effect.
Clinical parameters, including age, gender, development of proteinuria on study, and history of hypertension, diabetes, atherosclerosis, arterial thromboembolic events, venous thromboembolic events, and use of aspirin or a statin, were assessed for relationship to arterial thromboembolic event occurrence by univariate analysis and a Cox proportional hazards regression model.
Results:
Within this pooled population, the addition of bevacizumab to chemotherapy increased the risk of arterial thromboembolic events compared to chemotherapy alone (3.8% vs 1.7%, p < 0.01 by Chi-square test).
In addition to bevacizumab treatment, history of arterial thromboembolic events and age =65 years were identified as independent risk factors by multivariate analysis (hazard ratios of 1.9, 2.9, and 2.2 respectively).
Conclusion:
The addition of bevacizumab to chemotherapy is associated with an increased risk of arterial thromboembolic events in patients with metastatic carcinoma, especially those =65 years old with a prior history of arterial thromboembolic events.
The risk/benefit of bevacizumab in mCRC by arterial thromboembolic event-risk group will be presented.
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