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- Title
An Intergroup Randomized Phase II Study of Bevacizumab or Cetuximab in Combination with Gemcitabine and in Combination with Chemoradiation in Patients with Resected Pancreatic Carcinoma: A Trial of the ECOG-ACRIN Cancer Research Group (E2204).
- Authors
Berlin, Jordan D.; Feng, Yang; Catalano, Paul; Abbruzzese, James L.; Philip, Philip A.; McWilliams, Robert R.; Lowy, Andrew M.; Benson III, Al B.; Blackstock, A. William
- Abstract
Objectives: Evaluate toxicity of two treatment arms, A (cetuximab) and B (bevacizumab), when combined with gemcitabine, and chemoradiation in patients with completely resected pancreatic carcinoma. Secondary objectives included overall survival (OS) and disease-free survival (DFS). Methods: Patients with R0/R1 resection were randomized 1: 1 to cetuximab or bevacizumab administered in combination with gemcitabine for two treatment cycles. Next three cycles included concurrent cetuximab/bevacizumab plus chemoradiation, followed by one cycle of cetuximab/bevacizumab. Cycles 7-12 included cetuximab/bevacizumab with gemcitabine. Cycles were 2 weeks. Frequency of specific toxicities was summarized for each treatment arm at two times during the study, after chemotherapy but prior to chemoradiation and after all therapy. Results: A total of 127 patients were randomized (A, n = 65; B, n = 62). Prior to chemoradiation, the overall rate for toxicities of interest was 10% for arm A and 2% for arm B. After all therapy, the overall rates for toxicities of interest were 30 and 25% for arms A and B, respectively. Overall median OS and DFS were 17 and 11 months, respectively, which is not a significant improvement over expected survival rates for historical controls. Conclusions: Both treatments were tolerable with manageable toxicities, and were safe enough for a phase III trial had this been indicated.
- Subjects
CANCER chemotherapy; ANTIMETABOLITES; ADJUVANT treatment of cancer; PANCREATIC tumors; SURVIVAL analysis (Biometry); TOXICITY testing; SAMPLE size (Statistics); RANDOMIZED controlled trials; BEVACIZUMAB; DATA analysis software; DESCRIPTIVE statistics; CHEMORADIOTHERAPY
- Publication
Oncology, 2018, Vol 94, Issue 1, p39
- ISSN
0030-2414
- Publication type
Article
- DOI
10.1159/000480295