abstract
BACKGROUND:
In
response to the
critical shortage of liposomal doxorubicin (Doxil®) in
the United States, the Food and Drug Administration (FDA) approved
temporary importation of doxorubicin hydrochloride liposome (Lipodox®).
The objective was to
compare toxicity and clinical activity of Lipodox®
with Doxil®.
METHODS:
Recurrent
ovarian cancer patients who received Lipodox® were compared 3:1 to
matched control Doxil® patients who had received Doxil®. Patients were
matched based on age, stage, dose, platinum sensitivity, and prior
treatments from an existing de-identified database. Patients receiving
combination regimens were excluded.
RESULTS:
The
data from
40 Lipodox® patients was compared to 120 matched control
Doxil® patients.
In this study, 17 (42.5%) of the Lipodox® patients were
switched to Doxil®. The
overall response rate Lipodox® was 4.3% (1/23)
compared to 18% (20/111) in matched control Doxil® patients.
In the
platinum-sensitive patients, 100% progressed in the Lipodox® group
compared to 78.4% in matched control Doxil® patients. The mean time to
progression was 4.1 ± 2.8 months for Lipodox® and 6.2 ± 7.2 months in
control Doxil®s (p = 0·25). Toxicity was similar in the Lipodox® group
and control Doxil® group.
CONCLUSION:
Lipodox®
for treatment of recurrent ovarian cancer did not appear to have
equivalent efficacy compared to Doxil®. A prospective clinical study is
warranted before Lipodox® can be deemed equivalent substitution for
Doxil®.
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