1. ¹Department of Hematology and Oncology, Krankenhaus Nordwest, 60488 Frankfurt am Main, Frankfurt, Germany
2. ²Klinik Bad Trissl, Oberaudorf, Germany
3. ³Universitats-Frauenklinik/German BreastGroup, Frankfurt, Germany
4. ⁴Hämatologisch-Onkologische Praxis Altona, Hamburg, Germany
5. ⁵Krankenhaus Holweide, Köln, Germany
6. ⁶Klinikum Berlin-Buch, Berlin, Germany
7. ⁷Essex pharma, München, Germany
8. ⁸Frauenklinik Charité Campus Mitte, Berlin, Germany
9. ⁹Universitätsspital Zürich, Zürich, Switzerland

Correspondence: Dr S-E Al-Batran, E-mail: albatran@aol.com

Received 30 January 2006; Revised 6 April 2006; Accepted 6 April 2006; Published online 9 May 2006.

Abstract

This study evaluates the clinical benefit of pegylated liposomal doxorubicin (PLD) in patients with metastatic breast cancer (MBC), previously treated with conventional anthracyclines. Seventy-nine women with MBC previously treated with anthracyclines received PLD 50 mg m^-2 every 4 weeks. All patients were previously treated with chemotherapy and 30% of patients had 3 prior chemotherapies for metastatic disease. Patients were considered anthracycline resistant when they had disease progression on anthracycline therapy for MBC or within 6 months of adjuvant therapy. The overall clinical benefit rate (objective response+stable disease 24 weeks) was 24% (16.1% in patients with documented anthracycline resistance vs 29% in patients classified as having non-anthracycline-resistant disease). There was no difference with respect to the clinical benefit between patients who received PLD >12 months and those who received PLD 12 months since last anthracycline treatment for metastatic disease (clinical benefit 25 vs 24.1%, respectively). Median time to progression and overall survival were 3.6 and 12.3 months, respectively. The median duration of response was 12 months, and the median time to progression in patients with stable disease (any) was 9.5 months. Fourteen patients (17.7%) had a prolonged clinical benefit lasting 12 months. In conclusion, PLD was associated with an evident clinical benefit in anthracycline-pretreated patients with MBC.