Abstract
4573 Background: Preo chemoRT with weekly I/C and 5040 cGy followed by surgery is well tolerated [JCO 24: Abstract 4032; 2006]. ECOG trial E1201recently reported a median survival of 34 months with this preop regimen [JCO 26: Abstract 4532; 2008]. Bev + chemo improves response rate (RR) and time to progression (TTP) when added to weekly I/C in advanced esophagogastric cancer but does not increase chemo toxicity [JCO 24: 5201; 2006]. We are now combining in a Phase II trial Bev/I/C with concurrent radiotherapy (RT) in esophageal adenocarcinoma (EA) with the primary endpoint of safety. Methods: Patients (pts) with resectable Siewert's I or II EA were staged by EUS, PET, and CT. Induction chemo consisted of I-50–65 mg/m2 and C-30 mg/m2 weeks 1,2,4,5, Bev-7.5 mg/kg weeks 1 and 4; and, during RT (180 cGy daily to 5040 cGy), I/C was given weeks 7,8,10,11 and Bev weeks 7,10. Esophagectomy was 6–8 weeks after RT. A planned toxicity analysis was made in 10–15 pts completing chemoRT, and in 10 pts undergoing surgery: toxicity was acceptable if grade 3 / 4 hematologic toxicity remained < 72% and non hematologic toxicity < 40% during combined chemoRT (based on our prior phase II trial of I/C/RT [JCO 24: Abstract 4032; 2006]); and if pts undergoing surgery had no surgical complication related to Bev. Results: 18 pts have been enrolled, 12 male: 6 female; 7 Siewert I: 11 Siewert II; T3N1 12: T3N0 5: T2N0 1. 14 are evaluable for toxicity, 2 are too early, one progressed prior to RT, and one was taken off due to a CVA from a patent foramen ovale. Grade 3/4 neutropenia occurred in 4 pts (29%). Grade 3/4 non heme toxicity occurred in 5 pts (36%), including esophagitis 2 pts (14%), neutropenic fever 1 pt (7%), and pulmonary embolism 1 pt (7%). No grade 3 / 4 hypertension was seen, and 3 pts (21%) developed grade 1 proteinuria. Ten pts underwent surgery, and there were no unexpected surgical or wound complications; there were 2 anastomotic leaks. Pathologic responses: 1 pathologic CR and 1 T0N1. Conclusions: In a preliminary analysis of pts treated with Bev + preop chemoRT in EA, there was no increase in hematologic/non hematologic toxicity or Bev related surgical complications. Accrual will continue to 33 patients. Supported by Genentech. [Table: see text]
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