Analysis of survival with modified docetaxel, cisplatin, fluorouracil (mDCF), and bevacizumab (BEV) in patients with metastatic gastroesophageal (GE) adenocarcinoma: Results of a phase II clinical trial

4512 Background: Metastatic GE cancer is an aggressive disease with poor patient (pt) outcomes. Despite response rates of 30–60% to combination chemotherapy, response duration is usually 4–6 mo and 24-mo survival is 5–10%. The addition of BEV to chemotherapy has improved survival in several solid tumors, and has demonstrated encouraging activity in GE cancer (Shah et al, JCO 2006). We report mature tolerability and efficacy results of mDCF+BEV in GE cancer, with an emphasis on prolonged pt survival. Methods: Previously untreated metastatic GE pts with adequate end organ function received BEV 10mg/kg, Docetaxel 40mg/m2, FU 400mg/m2, Leucovorin 400mg/m2 on day 1, FU 1000 mg/m2/day x 2 days IVCI, and Cisplatin 40mg/m2 on day 3. Treatment is repeated every 14 days without prophylactic growth factor support. The primary objective is to improve 6-month progression free survival (PFS) from 43% (historical DCF control) to 63% with the addition of BEV. Target accrual is 44 evaluable pts, with 10% type I & II error...