TY - JOUR
T1 - 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
T2 - A Trial of the ECOG-ACRIN Cancer Research Group (E2204)
AU - Berlin, Jordan D.
AU - Feng, Yang
AU - Catalano, Paul
AU - Abbruzzese, James L.
AU - Philip, Philip A.
AU - McWilliams, Robert R.
AU - Lowy, Andrew M.
AU - Benson, Al B.
AU - Blackstock, A. William
N1 - Funding Information:
This study was coordinated by the ECOG-ACRIN Cancer Research Group (Robert L. Comis, MD, and Mitchell D. Schnall, MD, PhD, Group Co-Chairs) and supported in part by Public Health Service Grants CA180820, CA180794, CA180847, CA180790, CA03927, CA180857, CA31946, CA32102, CA38926 CA180888, CA180819, CA76429, CA25224, and from the National Cancer Institute, National Institutes of Health and the Department of Health and Human Services. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.
Publisher Copyright:
© 2017 S. Karger AG, Basel.
PY - 2018/1/1
Y1 - 2018/1/1
N2 - 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.
AB - 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.
KW - Bevacizumab
KW - Cetuximab
KW - Chemoradiation
KW - Randomized phase II
KW - Resected pancreatic carcinoma
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U2 - 10.1159/000480295
DO - 10.1159/000480295
M3 - Article
C2 - 29040974
AN - SCOPUS:85031816293
SN - 0030-2414
VL - 94
SP - 39
EP - 46
JO - Oncology
JF - Oncology
IS - 1
ER -