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Open Access Highly Accessed Research article

A multicentric observational trial of pegylated liposomal doxorubicin for metastatic breast cancer

Jens Huober1*, Werner Fett2, Arnd Nusch3, Michael Neise4, Marcus Schmidt5, Arthur Wischnik6, Steffen Gerhardt7, Thomas Goehler8, Hans-Joachim Lück9 and Andreas Rost10

Author Affiliations

1 Breast Center Kantonsspital, St Gallen, Switzerland

2 Oncological Practice, Wuppertal, Germany

3 Oncological Practice, Velbert, Germany

4 Oncological Practice, Krefeld, Germany

5 University of Mainz, Dept of Gynecology, Mainz, Germany

6 Clinical Center Augsburg, Augsburg, Germany

7 Oncological Practice, Gera, Germany

8 Oncological Practice, Dresden, Germany

9 Hannover Medical School, Hannover, Germany

10 Clinical Center Darmstadt, Darmstadt, Germany

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BMC Cancer 2010, 10:2  doi:10.1186/1471-2407-10-2

Published: 5 January 2010

Abstract

Background

Pegylated liposomal doxorubicin (PLD) is active in metastatic breast cancer. This observational study evaluated the efficacy and safety of PLD in patients treated during routine clinical practice.

Methods

Eligible patients had metastatic breast cancer and were treated with PLD according to the dose and schedule determined by their physician as part of routine practice. The primary objectives were to analyze the efficacy and toxicity of PLD therapy.

Results

125 patients were assessable. Median age was 62 years, 78% had performance status 0-1, and 60% had estrogen-receptor-positive disease. PLD treatment was second- or third-line in 69% of patients. Prior anthracyclines (adjuvant or metastatic) had been used in 56% of patients. The majority of patients (79%) received PLD every 4 weeks at a median dose of 40 mg/m2. Overall response rate was 43% in all patients and 34% in those previously treated with anthracyclines. The most common grade 3/4 adverse events were skin toxicity/hand-foot syndrome (6%), and leukopenia (3%).

Conclusions

This observational study supports the activity and tolerability of PLD in metastatic breast cancer as demonstrated in PLD clinical trials.