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• W1978900889 abstract "Bevacizumab is a humanized monoclonal antibody that prevents the binding of VEGF-a to its receptors, VEGF R-1 and R-2 (Flt-1 and KDR). Preclinical studies show that VEGF inhibition can increase radiosensitivity. Results from clinical trials of bevacizumab in combination with chemotherapy show promising activity against many different tumor types, including pancreatic cancer. This phase I trial was designed to study the safety of bevacizumab with chemoradiation in locally advanced pancreatic cancer. Correlative functional CT was planned to evaluate tumor blood flow and permeability changes. Entry criteria included patients with locally advanced (29/30) or medically inoperable (1/30) pancreatic adenocarcinoma based on CT criteria. Prior chemotherapy was allowed (18/30). Bevacizumab (5 mg/kg IV) was administered to all patients 2 weeks prior to the start of XRT (50.4 Gy treating the primary tumor and gross adenopathy), then every 2 weeks thereafter (2.5 mg/kg, n = 12, then 5 mg/kg n = 12). Capecitabine was administered continuously with radiotherapy on days 14–52 (650 mg/m2 PO BID for the first 6 patients, then 825 mg/m2 PO BID for the remaining patients. Patients with stable or responding disease were offered maintenance bevacizumab (5 mg/kg IV q 2 wks) until progression. Functional CT was performed on days 0, 14, and at the time of restaging (5 weeks after XRT). Twenty-four patients have completed treatment, 6 were under treatment at the time of analysis. The worst acute gastrointestinal toxicity during chemoradiation was grade 2 (NCI CTC v3) in 9 (38%) and grade 3 in 2 (8%) of patients. Five patients (21%) had G2 hand and foot syndrome. There was one patient each with grade 3 DVT, hypertension and joint pain, and leucopenia, respectively. There have been 3 grade 3 bleeding episodes possibly related to bevacizumab (2 GI and one GU, none during chemoradiation). All patients competed radiotherapy (3 with <5 day interruption), 10/24 (42%) had protocol-mandated 25% dose reductions of capecitabine due to grade 2 toxicity, and one dose of bevacizumab was held in one patient due to bleeding. Only one patient required hospitalization during chemoradiation. One of 12 patients treated at 2.5 mg/kg and 6 of 11 (56%) evaluable patients treated at 5 mg/kg achieved a partial response (50% reduction in maximum axial cross-sectional area). Only 1/23 patients (4%) have experienced objective local tumor progression. Based on functional CT, 3 patients had increased, one decreased, 2 no change in blood flow after the initial dose of bevacizumab. Eight patients’ scans were not interpretable due to artifacts secondary to organ motion, fluid/gas interface or biliary stents. Treatment with this novel combination of bevacizumab and chemoradiation is well tolerated with encouraging activity at the 5 mg/kg level of bevacizumab in locally advanced pancreatic cancer patients. We plan to continue enrollment on this study at 7.5 mg/kg and 10 mg/kg of bevacizumab. Randomized studies are planned to evaluate this regimen in both the locally advanced and the adjuvant setting. Financial support for this trial was provided by Genentech" @default.
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• W1978900889 date "2004-09-01" @default.
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• W1978900889 title "RhuMab VEGF (bevacizumab) with concurrent radiotherapy and capecitabine in locally advanced pancreatic cancer: An active, well tolerated regimen" @default.
• W1978900889 doi "https://doi.org/10.1016/j.ijrobp.2004.06.060" @default.
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