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10. Phase II study of single-agent pegylated liposomal doxorubicin HCl (PLD) in metastatic breast cancer after first-line treatment failure.

Author

Mlineritsch B, Mayer P, Rass C, Reiter E, Russ G, Vesenmayer G, Oberaigner W, and Hausmaninger H

Subjects
Adult, Aged, Antibiotics, Antineoplastic administration & dosage, Austria epidemiology, Bone Neoplasms diagnosis, Bone Neoplasms secondary, Breast Neoplasms diagnosis, Delayed-Action Preparations administration & dosage, Disease-Free Survival, Female, Humans, Liver Neoplasms diagnosis, Liver Neoplasms secondary, Lymphatic Metastasis, Middle Aged, Polyethylene Glycols, Survival Analysis, Treatment Outcome, Bone Neoplasms drug therapy, Bone Neoplasms mortality, Breast Neoplasms drug therapy, Breast Neoplasms mortality, Doxorubicin administration & dosage, Liver Neoplasms drug therapy, Liver Neoplasms mortality
Abstract

Objectives: Aim of this study was to evaluate the clinical benefit and the toxicity of pegylated liposomal doxorubicin., Patients and Methods: Patients with metastatic breast cancer (n = 30) who failed a prior chemotherapy regimen for metastatic disease received 45 mg/m2 pegylated liposomal doxorubicin (PLD) every 4 weeks following prophylactic administration of metoclopramide (10 mg) and dexamethasone (8 mg)., Results: 29 of 30 patients were assessed for clinical benefit and time to progression. All patients were assessed for toxicity and analysis of overall survival. 9 patients (31%) had a partial response, and 16 patients (55%) responded with stable disease, resulting in a clinical benefit rate of 86% (n = 25). Median time to progression was 4 months (95% CI: 2.8-5.2), median duration of response was 7 months (95% CI: 4.7-8.2), and median survival was 12 months (95% CI: 6.7-17.2). Skin toxicity was the most common adverse event (30%, all < or = grade 2). Other toxicities were remarkably low in occurrence., Conclusion: PLD is a well-tolerated, second-line monotherapy with a high rate of clinical benefit., (Copyright 2004 S. Karger GmbH, Freiburg.)

Published
2004
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