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Oncology. 2018;94(1):39-46. doi: 10.1159/000480295. Epub 2017 Oct 18.

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).

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1
Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.

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

PMID:
29040974
PMCID:
PMC5828967
[Available on 2019-01-01]
DOI:
10.1159/000480295
[Indexed for MEDLINE]
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