title: Phase II study of single-agent pegylated liposomal doxorubicin HCl (PLD) in metastatic breast cancer after first-line treatment failure.
abstract: OBJECTIVE
  Aim of this study was to evaluate the clinical benefit and the toxicity of pegylated liposomal doxorubicin.
  
  
  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.
  
  
  CONCLUSIONS
  PLD is a well-tolerated, second-line monotherapy with a high rate of clinical benefit.
authors.affiliation: Innere Medizin 3, Onkologische Abteilung, St. Johanns-Spital Salzburg, Austria. b.mlineritsch@lks.at
authors.forename: B
authors.initials: B
authors.lastname: Mlineritsch
authors.forename: P
authors.initials: P
authors.lastname: Mayer
authors.forename: C
authors.initials: C
authors.lastname: Rass
authors.forename: E
authors.initials: E
authors.lastname: Reiter
authors.forename: G
authors.initials: G
authors.lastname: Russ
authors.forename: G
authors.initials: G
authors.lastname: Vesenmayer
authors.forename: W
authors.initials: W
authors.lastname: Oberaigner
authors.forename: H
authors.initials: H
authors.lastname: Hausmaninger
mesh_terms: D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D001317:Austria / Q000453:epidemiology; D001859:Bone Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality* / Q000556:secondary; D001943:Breast Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality*; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality* / Q000556:secondary; D008207:Lymphatic Metastasis; D008875:Middle Aged; D011092:Polyethylene Glycols; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D003692:Delayed-Action Preparations; D011092:Polyethylene Glycols; D004317:Doxorubicin