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The Breast Avastin Trial: phase II study of bevacizumab maintenance therapy after induction chemotherapy with docetaxel and capecitabine for the first-line treatment of patients with locally recurrent or metastatic breast cancer

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Abstract

Background

Therapeutic approach for patients with metastatic breast cancer (MBC) is still controversial. This study was conducted to assess the efficacy and safety of bevacizumab in combination with docetaxel plus capecitabine as first-line treatment for MBC. The feasibility of bevacizumab maintenance therapy in this setting was also evaluated.

Patients and methods

In this single-arm, multicenter phase II study, patients received bevacizumab 15 mg/kg and docetaxel 60 mg/m2 on day 1, plus capecitabine 900 mg/m2 twice daily on days 1–14 every 21 days. Treatment was administered for up to 6 cycles, then bevacizumab continued until progressive disease. The primary end point was progression-free survival (PFS); secondary end points were tumor response rate, overall survival, and toxicity.

Results

Seventy-nine eligible patients were treated with bevacizumab in combination with docetaxel plus capecitabine. The overall response rate was 61 %, with a complete response rate of 8 % and a median duration of response of 10 months. At a median follow-up of 28 months, the median PFS was 11 months. Fifty-two (65 %) patients received bevacizumab maintenance therapy for a median duration of 7 months (range 1 to 33+). Neutropenia was the most common grade 3–4 toxicity (28.1 % of patients), and two fatal adverse events occurred (septic shock and gastrointestinal perforation).

Conclusions

Bevacizumab in combination with docetaxel and capecitabine demonstrates significant activity and quite acceptable toxicity profile as first-line treatment of MBC. Subsequent maintenance therapy with bevacizumab is feasible for a long period of stable disease. Results deserve confirmation.

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Acknowledgments

We thank all of the patients and Institutions involved in this study. The authors also thank Silvio Cavuto and Debora Formisano (S. Maria Nuova Hospital, Reggio Emilia) for statistical analysis. Medical writing assistance was provided by Andrea Bothwell in Science Communications, Springer Healthcare.

Conflict of interest

The authors declared that they have no conflict of interest.

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Authors and Affiliations

  1. Oncology Unit, Department of Oncology, Azienda Ospedaliera ASMN, Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy

    G. Bisagni, M. Panebianco, R. Gnoni, G. Moretti & C. Boni

  2. Medical Oncology Unit, Azienda Ospedaliero-Universitaria, Parma, Italy

    A. Musolino & A. Ardizzoni

  3. Medical Oncology Unit, Department of Senology, Istituto per lo studio e la cura dei tumori Fondazione “G. Pascale”, Naples, Italy

    A. De Matteis & F. Nuzzo

  4. Medical Oncology Department, Santa Maria della Misericordia Hospital, Perugia, Italy

    S. Gori

  5. Medical Oncology Unit, S.S. Trinità Hospital, Sora, Frosinone, Italy

    T. Gamucci

  6. Department of Oncology Unit, Istituti Ospitalieri Cremona, Cremona, Italy

    R. Passalacqua

Authors
  1. G. Bisagni
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  2. A. Musolino
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  3. M. Panebianco
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  4. A. De Matteis
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  5. F. Nuzzo
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  6. A. Ardizzoni
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  7. S. Gori
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  8. T. Gamucci
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  9. R. Passalacqua
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  10. R. Gnoni
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  11. G. Moretti
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  12. C. Boni
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Corresponding author

Correspondence to G. Bisagni.

Additional information

This study was conducted on behalf of the Italian Oncology Group for Clinical Research (GOIRC).

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Bisagni, G., Musolino, A., Panebianco, M. et al. The Breast Avastin Trial: phase II study of bevacizumab maintenance therapy after induction chemotherapy with docetaxel and capecitabine for the first-line treatment of patients with locally recurrent or metastatic breast cancer. Cancer Chemother Pharmacol 71, 1051–1057 (2013). https://doi.org/10.1007/s00280-013-2100-6

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  • DOI: https://doi.org/10.1007/s00280-013-2100-6

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