Vascular thromboembolic events in patients (pts) with advanced urothelial cancer (UC) treated with carboplatin/gemcitabine alone or in combination with bevacizumab
5074 Background: Vascular thromboembolic events (VTE) occur in 13% of UC pts treated with cisplatin-based therapy ( J Urol 160:2021, 1998). Carboplatin-based therapy is used in UC pts intolerant of cisplatin but the frequency of VTE is unknown. Bevacizumab added to chemotherapy increases VTE in non-small cell lung cancer (NSCLC; 5% vs 3%) (Oncologist 12:713, 2007), breast cancer (7.4% vs 5.5%) and colorectal cancer (19% vs 16%) (JAMA. 2008;300:2288). This study evaluated VTE in UC pts treated with carboplatin/gemcitabine alone or with bevacizumab. Methods: Pts with advanced UC treated on a Memorial Sloan-Kettering Cancer Center protocol from June 2006 to September 2008 were analyzed prospectively. Therapy included > 3 cycles of bevacizumab (15 mg/kg on day 1) plus carboplatin (AUC 5 or 4.5 on day 1) and gemcitabine (1000 mg/m2 on days 1,8) every 21 days. Evaluation for VTE on a contemporary UC control group of pts receiving carboplatin plus gemcitabine alone during the exact same time period was conducted retrospectively. VTE were defined as pulmonary embolism (PE), deep venous thrombosis (DVT), myocardial infarctions (MI) and cerebral vascular accidents (CVA). Pts with simultaneous PE and DVT were considered to have one VTE. Results: 89 pts were evaluated. Of the 25 pts treated with bevacizumab plus chemotherapy, 4 pts (16.0%; 95% CI 5–36%) had a VTE of which there were 2 PE alone, 1 DVT alone, and 1 DVT and PE. No MI was observed in bevacizumab-treated pts. Of the 64 contemporary control pts treated with gemcitabine plus carboplatin alone, there were 11 pts (17%; 95% CI 9–29%) who had a VTE of which there were 4 PE alone, 4 DVT alone, 2 DVT and PE, and 1 MI. No CVA were seen in either group. Conclusions: Pts with advanced UC receiving carboplatin plus gemcitabine have a very high rate of VTE (17%). The VTE incidence is similar to colon cancer (16%) and greater than NSCLC (3%) and breast cancer (5.5%). The VTE rate is similar for both cisplatin and carboplatin, suggesting that it is intrinsic to the UC disease state. In this study, the addition of bevacizumab to carboplatin/gemcitabine was not associated with an increase in VTE over that seen for carboplatin/gemcitabine alone. No significant financial relationships to disclose.