Evidence from clinical trials suggests that Caelyx, a pegylated liposomal formulation of doxorubicin, is among the most active second-line agents in the treatment of advanced ovarian cancer. Phase II studies with Caelyx given at a dose of 50 mg/m<sup>2</sup> every 3 or 4 weeks to patients with platinum-refractory disease reported response rates of approximately 25% and a median time to progression of about 6 months. In the third-line setting Caelyx achieved 17% responses among patients who were refractory to platinum, paclitaxel, and topotecan. Characteristic adverse effects of Caelyx were mucositis and palmar-plantar erythrodysesthesia (foot-hand syndrome) which however could be easily controlled with dose reductions or delays. Preliminary results from a randomized phase III trial suggest that Caelyx is equipotent with topotecan as second-line treatment. Several phase I/II studies of two- or three-drug combinations of Caelyx with other cytotoxic agents have recently been initiated. In the future, Caelyx is likely to be integrated even into first-line protocols for advanced ovarian cancer.
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