B F El-Rayes1, M Zalupski2, T Bekai-Saab3, L K Heilbrun4, N Hammad5, B Patel5, S Urba2, A F Shields5, U Vaishampayan5, S Dawson5, K Almhanna5, D Smith4, P A Philip5. 1. Department of Internal Medicine, Division of Hematology and Oncology, Karmanos Cancer Institute, Wayne State University, Detroit, MI. Electronic address: belraye@emory.edu. 2. Department of Internal Medicine, Division of Hematology and Oncology, University of Michigan, Ann Arbor, MI. 3. Department of Internal Medicine, Division of Hematology and Oncology, The Ohio State University, Arthur-James Cancer Center, Columbus, OH. 4. Department of Biostatisics, Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA. 5. Department of Internal Medicine, Division of Hematology and Oncology, Karmanos Cancer Institute, Wayne State University, Detroit, MI.
Abstract
BACKGROUND: Bevacizumab has demonstrated antitumor activity in multiple diseases. This phase II study was undertaken to determine the effects of adding bevacizumab to a regimen of docetaxel and oxaliplatin in patients with advanced adenocarcinoma of the stomach or gastroesophageal junction. PATIENTS AND METHODS: Previously untreated patients with locally advanced or metastatic disease and a performance status (PS) of 0-1 were eligible for this study. Patients received bevacizumab at 7.5 mg/kg, docetaxel at 70 mg/m(2), and oxaliplatin at 75 mg/m(2) administered on day 1 of a 21-day cycle. The primary end point of the study was progression-free survival (PFS). RESULTS: A total of 38 eligible patients (median age 57 years, 45% gastric, 55% PS 0) were enrolled on to the study. Median PFS was 6.6 months [95% confidence interval (CI) 4.4-10.5] and median survival 11.1 months (95% CI 8.2-15.3). Complete responses were documented in 2 (5%) patients, partial responses in 14 (37%), and stable disease in 14 (37%). No treatment-related deaths were observed. The most commonly reported grade 3-4 toxicity was neutropenia (34%), and gastrointestinal perforation occurred in three patients (8%). CONCLUSION: The combination of bevacizumab, docetaxel, and oxaliplatin has promising activity for further evaluation in randomized trials.
BACKGROUND:Bevacizumab has demonstrated antitumor activity in multiple diseases. This phase II study was undertaken to determine the effects of adding bevacizumab to a regimen of docetaxel and oxaliplatin in patients with advanced adenocarcinoma of the stomach or gastroesophageal junction. PATIENTS AND METHODS: Previously untreated patients with locally advanced or metastatic disease and a performance status (PS) of 0-1 were eligible for this study. Patients received bevacizumab at 7.5 mg/kg, docetaxel at 70 mg/m(2), and oxaliplatin at 75 mg/m(2) administered on day 1 of a 21-day cycle. The primary end point of the study was progression-free survival (PFS). RESULTS: A total of 38 eligible patients (median age 57 years, 45% gastric, 55% PS 0) were enrolled on to the study. Median PFS was 6.6 months [95% confidence interval (CI) 4.4-10.5] and median survival 11.1 months (95% CI 8.2-15.3). Complete responses were documented in 2 (5%) patients, partial responses in 14 (37%), and stable disease in 14 (37%). No treatment-related deaths were observed. The most commonly reported grade 3-4 toxicity was neutropenia (34%), and gastrointestinal perforation occurred in three patients (8%). CONCLUSION: The combination of bevacizumab, docetaxel, and oxaliplatin has promising activity for further evaluation in randomized trials.
Authors: Manish A Shah; Minaxi Jhawer; David H Ilson; Robert A Lefkowitz; Edric Robinson; Marinela Capanu; David P Kelsen Journal: J Clin Oncol Date: 2010-12-28 Impact factor: 44.544
Authors: Pamela L Kunz; Amirkaveh Mojtahed; George A Fisher; James M Ford; Daniel T Chang; Raymond R Balise; Charles D Bangs; Athena M Cherry; Reetesh K Pai Journal: Appl Immunohistochem Mol Morphol Date: 2012-01
Authors: Marwa Matboli; Sarah El-Nakeep; Nourhan Hossam; Alaa Habieb; Ahmed E M Azazy; Ali E Ebrahim; Ziad Nagy; Omar Abdel-Rahman Journal: World J Gastroenterol Date: 2016-07-14 Impact factor: 5.742