Imported Doxorubicin Similar to US FDA-Approved Brand in Relapsed/Refractory Ovarian Cancer

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Researchers retrospectively evaluated the electronic medical charts of patients who received either doxorubicin formulation.
Researchers retrospectively evaluated the electronic medical charts of patients who received either doxorubicin formulation.

In 2012, a commonly used drug for the treatment of recurrent or refractory ovarian cancer, known by the brand name Doxil®, ran out. These supply issues prompted the US Food and Drug Administration (FDA) to approve the emergency importation of a different formulation of the drug, this one known by the brand name Lipodox.

Both drugs utilized the agent doxorubicin, but the latter had not been approved by the US FDA and was not clinically confirmed to be the equivalent to Doxil before its emergency use. The first study to access the clinical outcomes of the 2 drug formulations in treating recurrent or refractory ovarian cancer was published in the Journal of Hematology Oncology Pharmacy.

The researchers retrospectively evaluated the electronic medical charts of patients who received either treatment. A total of 40 patients were included in the study; 16 received Doxil, 20 received Lipodox, and 4 received both Doxil and Lipodox.

Using the Response Evaluation Criteria in Solid Tumors, no significant difference in response rate was determined between patients treated with Doxil and those treated with Lipodox. Time to progression, determined objectively based on imagining or symptomatic progression, was 213 days for the Lipodox group and 123 days for the Doxil group.

Further studies are needed to determine if there is a benefit to receiving both drugs. “In our study, only 4 patients received both drugs, which was too small a sample to analyze,” wrote the authors. “If more patients are analyzed in future research, it would be interesting to see if there is benefit in receiving both Doxil and Lipodox.” In the meantime, the results of this study suggest that either drug could be used in the event of future drug shortages.

Reference

Shen E, Amerine LB, Gardiner M. Comparing outcomes in patients with recurrent or refractory ovarian cancer managed with 1 of 2 versions of pegylated liposomal doxorubicin at an academic medical center. J Hematol Oncol Pharm. 2018;8:4.
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