Preliminary safety data from a randomized trial of perioperative epirubicin, cisplatin plus capecitabine (ECX) with or without bevacizumab (B) in patients (pts) with gastric or oesophagogastric junction (OGJ) adenocarcinoma.

Abstract

4019 Background: Perioperative chemotherapy is a standard of care for localised oesophagogastric cancer. B is a monoclonal antibody targeting vascular endothelial growth factor (VEGF), a potent regulator of angiogenesis. Tumour VEGF expression and high preoperative serum VEGF are independent predictors of poor prognosis for resected gastric cancer. ST03 is an ongoing randomised phase II/III trial of perioperative ECX ± B in pts with operable gastric or OGJ adenocarcinoma. Methods: Pts receive 3 preoperative and 3 postoperative ECX ± B 7.5 mg/kg, then 6 × maintenance B in the experimental arm only. The Independent Data Monitoring Committee undertook a preplanned review of preliminary safety data relating to preoperative chemotherapy and surgery for the first 104 pts. We present these data here to reassure clinicians and patients involved in the trial. Results: 43 ECX and 42 ECX + B pts have completed preoperative chemotherapy, 38 (88%) and 37 (88%) respectively received all 3 cycles. Of the 10 pts who received < 3 cycles, 7 (3 ECX, 4 ECX+B) stopped due to toxicity. B was administered in all preoperative cycles in the ECX + B arm. 7 ECX and 4 ECX + B patients experienced a total of 12 notable adverse events during preoperative chemotherapy: venous thromboembolic events (5 ECX, 1 ECX+B), gastric perforations (1 ECX, 1 ECX+B), haemorrhagic events (1 ECX, 1 ECX + B), hypertension (1 ECX + B) and wound complication from previous laparoscopy (1 ECX + B). Surgical data on the first 104 pts are immature but will be complete at the time of presentation. 51 (27 ECX, 24 ECX + B) pts have undergone gastrectomy. 6 pts (3 ECX, 3 ECX + B) had postoperative wound healing complications. 2 ECX + B pts had other notable events (reversible posterior leucoencephalopathy syndrome possibly due to B + microangiopathic haemolytic anaemia due to disease progression in the bone marrow). Conclusions: Preliminary safety data indicate acceptable and similar rates of complications in the 2 arms. 154 pts have been randomised to Jan. 8, 2010; safety and feasibility of ECX + B will be formally assessed when 200 pts have completed preoperative treatment. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Roche Roche Roche Roche