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Results from an observational trial with oral vinorelbine and trastuzumab in advanced breast cancer

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Abstract

Purpose

We evaluated the efficacy and tolerability of oral vinorelbine plus trastuzumab (OV + T) in Her2 positive advanced breast cancer as first line chemotherapy or after progressing on earlier treatment.

Patients and methods

Thirty consecutive patients (median age: 59 years) were included. Patients received OV in a dose of 60 mg/m2 on day 1 and 8, q = 21, without dose escalation. Trastuzumab was administered every 3 weeks at a dose of 6 mg/kg bodyweight after a loading dose of 8 mg/kg. Response was evaluated every three cycles using UICC criteria. Time to progression (TTP) and overall survival (OS) were estimated using the Kaplan–Meier product limit method. A multivariate analysis was performed to evaluate factors potentially influencing response rate and TTP.

Results

Median time of observation was 20 months. We observed a complete response in 18% of patients, partial remission in 50%, stable disease ≥ 6 months in 21%, and progressive disease in 11%. TTP was median 9 months. OS was not reached. Response rate and TTP were influenced by line of treatment only. The main toxicities consisted of neutropenia and nausea.

Conclusions

OV + T appears to be an effective and safe treatment option in advanced breast cancer at the dose and schedule chosen.

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Authors and Affiliations

  1. Department of Internal Medicine I, Division of Oncology, Medical University of Vienna, 18-20 Waehringer Guertel, A-1090, Vienna, Austria

    Rupert Bartsch, Catharina Wenzel, Gabriela Altorjai, Ursula Pluschnig, Gottfried J. Locker, Robert Mader, Christoph C. Zielinski & Guenther G. Steger

  2. Department of Surgery, Medical University of Vienna, Vienna, Austria

    Thomas Bachleitner-Hoffmann

  3. Department of Pathology, Medical University of Vienna, Vienna, Austria

    Margaretha Rudas

Authors
  1. Rupert Bartsch
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  2. Catharina Wenzel
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  3. Gabriela Altorjai
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  4. Ursula Pluschnig
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  5. Thomas Bachleitner-Hoffmann
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  6. Gottfried J. Locker
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  7. Margaretha Rudas
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  8. Robert Mader
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  9. Christoph C. Zielinski
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  10. Guenther G. Steger
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Corresponding author

Correspondence to Guenther G. Steger.

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Bartsch, R., Wenzel, C., Altorjai, G. et al. Results from an observational trial with oral vinorelbine and trastuzumab in advanced breast cancer. Breast Cancer Res Treat 102, 375–381 (2007). https://doi.org/10.1007/s10549-006-9342-5

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  • DOI: https://doi.org/10.1007/s10549-006-9342-5

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