A phase ii pilot trial incorporating bevacizumab into dose-dense doxorubicin and cyclophosphamide followed by paclitaxel in patients with lymph node positive breast cancer: A trial coordinated by the Eastern Cooperative Oncology Group

K. D. Miller, A. O'neill, E. A. Perez, A. D. Seidman, G. W. Sledge

Research output: Contribution to journalArticlepeer-review

19 Scopus citations

Abstract

Background: E2104 was designed to evaluate the safety of two different strategies incorporating bevacizumab into anthracycline-containing adjuvant therapy as a precursor to a definitive randomized phase III trial. Patients and methods: Patients were sequentially assigned to one of two treatment arms. In addition to dose-dense doxorubicin and cyclophosphamide followed by paclitaxel (Taxol) (ddAC→T), all patients received bevacizumab (10 mg/kg every 2 weeks × 26) initiated either concurrently with AC (Arm A: ddBAC→BT→B) or with paclitaxel (Arm B: ddAC→BT→B). The primary end point was incidence of clinically apparent cardiac dysfunction (CHF). Results: Patients enrolled were 226 in number (Arm A 104, Arm B 122). Grade 3 hypertension, thrombosis, proteinuria and hemorrhage were reported for 12, 2, 2 and <1% of patients, respectively. Two patients developed grade 3 or more cerebrovascular ischemia. Three patients in each arm developed CHF. There was no significant difference between arms in the proportion of patients with an absolute decrease in left ventricular ejection fraction of >15% or >10% to below the lower limit of normal post AC or post bevacizumab. Conclusions: Incorporation of bevacizumab into anthracycline-containing adjuvant therapy does not result in prohibitive cardiac toxicity. The definitive phase III trial (E5103) was activated with systematic and extensive cardiac monitoring to define the true impact of bevacizumab on cardiac function.

Original languageEnglish (US)
Pages (from-to)331-337
Number of pages7
JournalAnnals of Oncology
Volume23
Issue number2
DOIs
StatePublished - Feb 2012

Keywords

  • Angiogenesis
  • Breast cancer
  • Cardiomyopathy
  • Clinical trial
  • Vascular endothelial growth factor

ASJC Scopus subject areas

  • Hematology
  • Oncology

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