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Updated data compares DOXIL (R)/CAELYX (TM) (doxorubicin HCl liposome injection) to Topotecan

Bridgewater, NJ, November 4, 2003 Researchers have presented updated data comparing DOXIL/CAELYX (doxorubicin HCl liposome injection) to topotecan HCl in patients with recurrent ovarian cancer. These data, from a randomized, controlled, multi-center, open-label, Phase III clinical study, were presented during a poster session at the 12th meeting of the Federation of European Cancer Societies (ECCO 12) in Copenhagen, Denmark.1

The National Cancer Institute estimates that in 2003, 25,000 American women will be diagnosed with ovarian cancer, and 14,000 women will die from it.2 This analysis compared DOXIL and topotecan another common treatment for recurrent ovarian cancer in epithelial ovarian cancer patients whose disease recurred after or did not respond to first-line, platinum-based chemotherapy. The primary objective of this long-term follow up analysis was to measure the overall survival and progression-free survival of these patients.

Researchers reported the median overall survival was three weeks longer for patients treated with DOXIL compared to those treated with topotecan (63 and 60 weeks, respectively, HR 0.82 [95 percent CI = 0.68 to 1.00]; p = 0.05). In addition, the overall progression-free survival was 16.1 weeks for DOXIL compared to 17.0 weeks topotecan (HR 0.88 [95 percent CI = 0.73 to 1.06]; p = 0.171).

Among platinum-sensitive patients (those who had a PFS interval of greater than six months after first-line, platinum-based chemotherapy), the median survival of patients receiving DOXIL was 112 weeks versus 77 weeks for patients receiving topotecan (HR 0.63 [95 percent CI = 0.47 to 0.85]; p = 0.002). DOXIL patients also saw a significant advantage in median PFS versus those receiving topotecan (28.9 and 23.1 weeks, respectively, HR = 0.76 [95 percent CI = 0.58 to 1.00]; p = 0.046).

In the subset of patients with platinum-refractory disease (those whose disease progressed during in
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