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Clinical Trial
. 2010 Jan 5:10:2.
doi: 10.1186/1471-2407-10-2.

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

Jens Huober  1 , Werner Fett, Arnd Nusch, Michael Neise, Marcus Schmidt, Arthur Wischnik, Steffen Gerhardt, Thomas Goehler, Hans-Joachim Lück, Andreas Rost
Affiliations
Clinical Trial

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

Jens Huober et al. BMC Cancer. .

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.

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Figures

Figure 1
Figure 1
Overall and Progression-Free Survival. (A) Kaplan-Meier estimates of overall survival and progression-free survival in patients treated with PLD for metastatic breast cancer. (B) Kaplan-Meier estimates of overall survival and progression-free survival in anthracycline-pretreated patients treated with PLD for metastatic breast cancer.
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