Is It Equivalent? Evaluation Of The Clinical Activity Of Single Agent Lipodox (R) Compared To Single Agent Doxil (R) In Ovarian Cancer Treatment

Background: In response to the critical shortage of liposomal doxorubicin (Doxil (R)) in the United States, the Food and Drug Administration (FDA) approved temporary importation of doxorubicin hydrochloride liposome (Lipodox (R)). The objective was to compare toxicity and clinical activity of Lipodox (R) with Doxil (R).Methods: Recurrent ovarian cancer patients who received Lipodox (R) were compared 3: 1 to matched control Doxil (R) patients who had received Doxil (R). 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 (R) patients was compared to 120 matched control Doxil (R) patients. In this study, 17 (42.5%) of the Lipodox (R) patients were switched to Doxil (R). The overall response rate Lipodox (R) was 4.3% (1/23) compared to 18% (20/111) in matched control Doxil (R) patients. In the platinum-sensitive patients, 100% progressed in the Lipodox (R) group compared to 78.4% in matched control Doxil (R) patients. The mean time to progression was 4.1 +/- 2.8 months for Lipodox (R) and 6.2 +/- 7.2 months in control Doxil (R) s (p = 0.25). Toxicity was similar in the Lipodox (R) group and control Doxil (R) group.Conclusion: Lipodox (R) for treatment of recurrent ovarian cancer did not appear to have equivalent efficacy compared to Doxil (R). A prospective clinical study is warranted before Lipodox (R) can be deemed equivalent substitution for Doxil (R).