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

6 Scopus citations

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

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Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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