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Non-pegylated liposomal doxorubicin and docetaxel in metastatic breast cancer: final results of a phase II trial

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Abstract

Background

Non-pegylated liposomal doxorubicin (NPLD) has demonstrated equivalent antitumor activity to conventional doxorubicin and a significantly lower risk of cardiotoxicity when given as single agent or in combination with cyclophosphamide, but there is limited experience with the combination of NPLD and taxanes. This phase II study was performed to evaluate the efficacy and safety of the NPLD and docetaxel in patients with metastatic breast cancer.

Patients and methods

A total of 51 patients were treated with NPLD (60 mg/m2) and docetaxel (75 mg/m2) in 3-weeks intervals for up to eight cycles.

Results

The overall response rate was 50% and 78% of patients derived a clinical benefit. Median time to progression and overall survival were 10.0 months (95% CI, 6.9–13.1 months) and 25 months (95% CI, 22.1–29.8 months), respectively. Median duration of response was 12.0 months (95% CI 7.1–16.9). The treatment was generally well tolerated and associated with toxicities that were consistent with the known side-effects of the individual agents and of anthracycline/taxane combinations. There were no symptomatic cardiac averse events and mild asymptomatic LVEF changes were reported in five patients.

Conclusions

The combination of NPLD and docetaxel is well tolerated and has high antitumour activity in MBC patients.

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Acknowledgments

This study was supported by grants from Cephalon Pharma, Germany, Aventis Pharmaceutical, Germany and Amgen Pharmaceutical, Germany.

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Authors and Affiliations

  1. Department of Medical Oncology, Charing Cross Hospital, Imperial College London, Fulham Palace Road, London, W6 8RF, UK

    Peter Schmid

  2. Department of Obstetrics and Gynecology, Sana Hospital Lichtenberg, Berlin, Germany

    J. Krocker & D. Elling

  3. Department of Obstetrics and Gynecology, University of Ulm, Ulm, Germany

    R. Kreienberg

  4. Clinic for Gynaecological Oncology, Berlin, Germany

    P. Klare & K. Kittel

  5. Department of Obstetrics and Gynecology, Ludwig Maximilians University Munich, Munich, Germany

    H. Sommer

  6. Clinic for Gynaecological Oncology, Fürstenwalde, Germany

    G. Heinrich

  7. Department of Obstetrics and Gynecology, Hospital Chemnitz, Chemnitz, Germany

    T. Steck

  8. Department of Obstetrics and Gynecology, Charité University Medical Center, Berlin, Germany

    W. Lichtenegger

  9. Department of Obstetrics and Gynecology, University Hospital Essen, Essen, Germany

    S. Kümmel

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  1. Peter Schmid
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  2. J. Krocker
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Correspondence to Peter Schmid.

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Schmid, P., Krocker, J., Kreienberg, R. et al. Non-pegylated liposomal doxorubicin and docetaxel in metastatic breast cancer: final results of a phase II trial. Cancer Chemother Pharmacol 64, 401–406 (2009). https://doi.org/10.1007/s00280-008-0887-3

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  • DOI: https://doi.org/10.1007/s00280-008-0887-3

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