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Open Access Highly Accessed Research article

Maintenance bevacizumab beyond first-line paclitaxel plus bevacizumab in patients with Her2-negative hormone receptor-positive metastatic breast cancer: efficacy in combination with hormonal therapy

Alessandra Fabi1*, Michelangelo Russillo1, Gianluigi Ferretti1, Giulio Metro1, Cecilia Nisticò1, Paola Papaldo1, Ferdinando De Vita2, Giuliana D’Auria3, Antonello Vidiri4, Diana Giannarelli5 and Francesco Cognetti1

Author affiliations

1 Division of Medical Oncology A, Regina Elena National Cancer Institute, Via Elio Chianesi 53, Rome, Italy

2 Division of Medical Oncology, Second University of Naples School of Medicine, II Policlinico, Naples, Italy

3 Division of Medical Oncology, Belcolle Hospital, Viterbo, Italy

4 Diagnostic Imaging Department, Regina Elena National Cancer Institute, Rome, Italy

5 Service of Biostatistics, Regina Elena National Cancer Institute, Rome, Italy

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Citation and License

BMC Cancer 2012, 12:482  doi:10.1186/1471-2407-12-482

Published: 19 October 2012

Abstract

Background

Data on efficacy of bevacizumab (B) beyond first-line taxane -including regimen (BT) as first-line treatment are lacking. Although preclinical results that anti-angiogenic agents combined with hormonal therapy (HT) could be active, no clinical data exist about combination of maintenance Bevacizumab (mBev) with HT.

Methods

Thirty-five patients who experienced a response after first-line BT, were given mBev at the dose of 15 mg/kg every 3 weeks. Among 30 pts with hormonal receptor-positive metastatic breast cancer (MBC), 20 (66.6%) received HT with mBev (mHTBev). Objective of the study was the outcome and safety of mBev and in two groups of patients receiving HT or not.

Results

Complete response and partial response was achieved/maintained in 4 (11.4%) and 13 (37.1%) patients, respectively (overall response rate: 48.5%). Clinical benefit was obtained on 23 patients (65.7%). Median of mBev PFS and clinical benefit were 6.8 months (95% CI: 0.8-12.7) and 17.1 months (95% CI :12.2-21.9), respectively. Median PFS of patients who received mHTBev was longer than mBev without HT (13 months and 4.1 months, respectively, p = 0.05). The most common severe toxicities were proteinuria (11.4%) and hypertension (8.5%). No additional toxicity was observed with HTBev.

Conclusion

Maintenance bevacizumab with or without anti-hormonal therapy in patients with hormone receptor positive breast cancer is tolerable and associated with long-term clinical outcome; these results encourage the strategy of prolonging bevacizumab until progression in combination with anti-hormonal agents.

Keywords:
Maintenance Bevacizumab; Antiangiogenic agents; HER2 negative metastatic breast cancer