Bevacizumab, Oxaliplatin, and Capecitabine With Radiation Therapy in Rectal Cancer: Phase I Trial Results

摘要: Purpose: The overexpression of vascular endothelial growth factor (VEGF) is associated with poor outcomes in colorectal cancer patients. Bevacizumab, a VEGF inhibitor, enhances the effects chemotherapy and radiation therapy on tumor cytotoxicity preclinical models, including cancer. A Phase I trial was undertaken to evaluate combination bevacizumab, capecitabine, oxaliplatin, patients rectal Methods Materials: Patients pathologically confirmed adenocarcinoma rectum were eligible. Pretreatment staging included computerized tomography, endoscopic ultrasound, surgical evaluation. received 50.4 Gy external beam (EBRT) 28 fractions. Capecitabine, bevacizumab administered concurrently therapy. After EBRT completion, restaged evaluated for surgery. Primary endpoints determination dose-limiting toxicity recommended II dose, non toxicity, preliminary radiographic pathologic response rates. Results: Eleven enrolled. All evaluable efficacy. Dose level 2 unacceptable (primarily diarrhea). 1 had an acceptable profile. dose our study 15 mg/kg Day + 10 Days 8 22, oxaliplatin 50 mg/m{sup 2} weekly,more » capecitabine 625 bid during days. Six clinical responses. Two complete response, 3 microscopic disease only. One patient experienced postoperative abscess, one syncopal episode adjuvant chemotherapy, subclinical myocardial infarction chemotherapy. Conclusions: tolerable, encouraging Further investigation this regimen being pursued setting.« less