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

*Corresponding author for this work

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.
@article{ac5c67a68075440d8e20f4072bc6a6ae,
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)",
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.",
keywords = "Bevacizumab, Cetuximab, Chemoradiation, Randomized phase II, Resected pancreatic carcinoma",
author = "Berlin, {Jordan D.} and Yang Feng and Paul Catalano and Abbruzzese, {James L.} and Philip, {Philip A.} and McWilliams, {Robert R.} and Lowy, {Andrew M.} and Benson, {Al B.} and Blackstock, {A. William}",
year = "2018",
month = "1",
day = "1",
doi = "10.1159/000480295",
language = "English (US)",
volume = "94",
pages = "39--46",
journal = "Oncology",
issn = "0890-9091",
publisher = "UBM Medica Healthcare Publications",
number = "1",

}

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

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

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

UR - http://www.scopus.com/inward/record.url?scp=85031816293&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85031816293&partnerID=8YFLogxK

U2 - 10.1159/000480295

DO - 10.1159/000480295

M3 - Article

VL - 94

SP - 39

EP - 46

JO - Oncology

JF - Oncology

SN - 0890-9091

IS - 1

ER -