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).

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Berlin, JD; Feng, Y; Catalano, P; Abbruzzese, JL; Philip, PA; McWilliams, RR; Lowy, AM; Benson, AB; Blackstock, AW

Published Date

  • January 2018

Published In

Volume / Issue

  • 94 / 1

Start / End Page

  • 39 - 46

PubMed ID

  • 29040974

Pubmed Central ID

  • 29040974

Electronic International Standard Serial Number (EISSN)

  • 1423-0232

International Standard Serial Number (ISSN)

  • 0030-2414

Digital Object Identifier (DOI)

  • 10.1159/000480295

Language

  • eng