Phase II study of single-agent pegylated liposomal doxorubicin HCl (PLD) in metastatic breast cancer after first-line treatment failure.
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.
Mlineritsch
B
B
Innere Medizin 3, Onkologische Abteilung, St. Johanns-Spital Salzburg, Austria. b.mlineritsch@lks.at
Mayer
P
P
Rass
C
C
Reiter
E
E
Russ
G
G
Vesenmayer
G
G
Oberaigner
W
W
Hausmaninger
H
H
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
D000903:Antibiotics, Antineoplastic; D003692:Delayed-Action Preparations; D011092:Polyethylene Glycols; D004317:Doxorubicin