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. 2014 May 12:3:244.
doi: 10.1186/2193-1801-3-244. eCollection 2014.

Cardiac safety results from a phase II, open-label, multicenter, pilot study of two docetaxel-based regimens plus bevacizumab for the adjuvant treatment of subjects with node-positive or high-risk node-negative breast cancer

Sara A Hurvitz  1 , Linda D Bosserman  2 , David Chan  3 , Christopher T Hagenstad  4 , Frederick C Kass  5 , Frederick P Smith  6 , Gladys I Rodriguez  7 , Barrett H Childs  8 , Dennis J Slamon  1
Affiliations

Cardiac safety results from a phase II, open-label, multicenter, pilot study of two docetaxel-based regimens plus bevacizumab for the adjuvant treatment of subjects with node-positive or high-risk node-negative breast cancer

Sara A Hurvitz et al. Springerplus. .

Abstract

Purpose: Adding antiangiogenic therapy to standard chemotherapy has improved response rates and progression-free survival in metastatic breast cancer (BC) patients. This phase II study evaluated cardiac safety of bevacizumab with/without trastuzumab with two docetaxel-based regimens in early BC.

Methods: 127 women with non-metastatic node-positive or high-risk node-negative BC were enrolled. Women with human epidermal growth factor receptor 2 (HER2)-negative BC (n = 93) received docetaxel/doxorubicin/cyclophosphamide (TAC) + bevacizumab, while women with HER2-positive disease (n = 34) received docetaxel/carboplatin/trastuzumab (TCH) + bevacizumab, every 3 weeks for six cycles. Maintenance therapy with bevacizumab alone or bevacizumab plus trastuzumab, respectively, was given every 3 weeks for 52 weeks. The primary objective was to evaluate cardiac safety, as measured by the incidence of ≥ grade 3 clinical congestive heart failure (CHF); the secondary objective was assessment of safety and toxicity.

Results: At least one cardiac adverse event (AE; CHF, cardiomyopathy, or left ventricular dysfunction) was reported in 26.1% of TAC (n = 92) and 17.6% of TCH subjects (n = 34); there were no cardiac deaths. ≥ Grade 3 clinical CHF was observed in 4.3% in the TAC plus bevacizumab stratum and 0% in the TCH plus bevacizumab stratum. A ≥ grade 3 treatment-emergent AE (any kind) related to study treatment was observed in 59.8% in the TAC with bevacizumab and 52.9% in the TCH plus bevacizumab stratum.

Conclusion: Adding bevacizumab to a docetaxel-based regimen with trastuzumab did not appear to increase cardiotoxicity.

Trial registration: ClinicalTrials.gov Identifier: NCT00446030, registered March 8, 2007.

Keywords: Adverse events; Anthracyclines; Antiangiogenic; Congestive heart failure; Trastuzumab.

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Figures

Figure 1
Figure 1
Study design. Abbreviations: HER2/neu = human epidermal growth factor receptor-2; TAC = docetaxel, doxorubicin, cyclophosphamide; TCH = docetaxel, carboplatin, trastuzumab.
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