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)

Jordan D. Berlin, Yang Feng, Paul Catalano, James L. Abbruzzese, Philip A. Philip, Robert R. McWilliams, Andrew M. Lowy, Al B. Benson, A. William Blackstock

Research output: Contribution to journalArticle

3 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)39-46
Number of pages8
JournalOncology (Switzerland)
Volume94
Issue number1
DOIs
StatePublished - Jan 1 2018

Fingerprint

gemcitabine
Research
Neoplasms
Disease-Free Survival
Therapeutics
Survival
Pancreatic Carcinoma
Bevacizumab
Cetuximab
Survival Rate
Drug Therapy

Keywords

  • Bevacizumab
  • Cetuximab
  • Chemoradiation
  • Randomized phase II
  • Resected pancreatic carcinoma

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Berlin, Jordan D. ; Feng, Yang ; Catalano, Paul ; Abbruzzese, James L. ; Philip, Philip A. ; McWilliams, Robert R. ; Lowy, Andrew M. ; Benson, Al B. ; Blackstock, A. William. / 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). In: Oncology (Switzerland). 2018 ; Vol. 94, No. 1. pp. 39-46.
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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.",
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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). / Berlin, Jordan D.; Feng, Yang; Catalano, Paul; Abbruzzese, James L.; Philip, Philip A.; McWilliams, Robert R.; Lowy, Andrew M.; Benson, Al B.; Blackstock, A. William.

In: Oncology (Switzerland), Vol. 94, No. 1, 01.01.2018, p. 39-46.

Research output: Contribution to journalArticle

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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

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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