Recently the Food and Drug Administration (FDA) granted full approval for Doxil® for patients with recurrent ovarian cancer who have failed platinum-based chemotherapy.[1] Previously, Doxil® had only been indicated for patients with metastatic disease who had not responded to either platinum or taxane-based therapy.

The initial approval for Doxil® for treatment of recurrent ovarian cancer had been based on response rates. The new studies reviewed by the FDA included improvements in overall survival time and overall response rates. One trial included 474 women with recurrent ovarian cancer.[2] Patients were randomized to receive either Doxil® (50mg/m2) every 4 weeks or Hycamtin® (topotecan) (1.5mg/m2/day) for 5 consecutive days, every 3weeks. Results of the study indicated that although the time to disease progression was not significantly different between the two groups, overall survival was improved with Doxil® when compared to Hycamtin® (14.4 months vs. 13.7months). Overall response rates were 19.7% in the Doxil® group, compared to 17% among the Hycamtin® group. Researchers concluded that Doxil® appears to be a reasonable treatment alternative to Hycamtin® as a second-line therapy in ovarian cancer patients.

In a previous Spanish study, it was concluded that Doxil® was more cost-effective than Hycamtin® for patients with recurrent ovarian cancer and produced equivalent benefits.[3] These authors stated that the costs of the two drugs were equivalent, but that the costs of managing adverse events were higher for the Hycamtin®-treated patients (3304 euros) compared to the Doxil®-treated patients (967 euros). This analysis confirmed an American study published last year in the Annals of Oncology.[4]

Doxil® prescribing information can be obtained at: http://www.doxil.com/common/prescribing_information/DOXIL/PDF/DOXIL_PI_Booklet.pdf.

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