Abstract
4602 Background: Vascular endothelial growth factor (VEGF)-targeted therapies have shown to be active in several malignancies. Pre-clinical evidence suggests that VEGF plays a role in the homeostasis and regeneration of the myocardium. Some trials with VEGF inhibitors have reported congestive heart failure (CHF), although the overall incidence and relative risk (RR) remains unclear. We did a meta-analysis to determine the risk associated with the use of Food and Drug Administration (FDA)-approved VEGF targeted agents. Methods: The databases of Medline were searched for articles from 1966 to Dec. 2009. Abstracts presented at the American Society of Clinical Oncology (ASCO) meetings were searched for relevant clinical trials. Randomized phase II or III trials with bevacizumab (BEV), sunitinib (SUN), sorafenib (SOR) or pazopanib (PAZ), reporting grade 3/4 CHF, were included in the analysis. Statistical analyses were conducted to calculate the summary incidence, RR and 95% confidence intervals (CI), using random-effects or fixed-effects models based on the heterogeneity of included studies. Results: A total of 6,586 patients from 11 randomized trials were included. We found no PAZ or SOR randomized trials reporting CHF. Overall incidence for high grade CHF with BEV and SUN- was 1.8% (RR 1.98; 95% CI, 1.18-3.35, p=.01). Stratified analyses by drug type or underlying malignancy demonstrated a higher RR with SUN, RR 3.04 (1.07-8.64, p=.036) vs. BEV, RR 1.72 (0.94-3.15, p=.080), and a higher RR with breast cancer, RR 3.33 (1.41-7.82, p=.006) vs. non- breast cancer patients, RR 1.46 (0.75-2.82, p=.27). No significant differences by drug type or underlying malignancy were found (p=.60 and p=.23, respectively). No evidence of publication bias or heterogeneity among studies was detected. Conclusions: This is the first meta- analysis to show that BEV and SUN treatment is associated with an increased risk of CHF. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Abbott Laboratories, Agennix, Bayer/Onyx Pharmaceuticals, Genentech, GlaxoSmithKline, Novartis, Pfizer
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