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PLD Extends Survival Among Advanced Ovarian Cancer Patients: Presented at CFS
By Charlene Laino
NEW YORK, NY -- November 15, 2004 -- Treatment with pegylated liposomal doxorubicin (PLD) significantly prolongs survival compared with topotecan in patients with recurrent and refractory epithelial ovarian cancer, a phase 3 study shows.
The survival benefit of PLD is pronounced in patients with platinum-sensitive disease, Alan N. Gordon, MD, clinical professor of obstetrical gynecology, University of Arizona, Phoenix, Arizona, reported here on November 11th at the Chemotherapy FOUNDATIONS Symposium XXII: Innovative Cancer Therapy for Tomorrow.
In the study, patients with epithelial ovarian cancer that recurred after or failed to respond to first-line platinum-based chemotherapy were randomized to receive 50 mg/m2 of PLD every 28 days or 1.5 mg/m2/day of topotecan for 5 days every 21 days. Most patients had been previously treated with platinum and taxanes: 74% in the PLD group and 72% in the topotecan arm.
Median overall survival among the 239 patients treated with PLD was 63 weeks, compared with 60 weeks for the 235 patients treated with topotecan, corresponding to a risk reduction of 18% (P =.032). Dr. Gordon noted that the survival data are mature, with less than 10% of patients still alive.
In patients with platinum-refractory disease, survival was similar between treatment groups, he said.
But among patients with platinum-sensitive disease, there was a 30% reduction in the risk of death for the PLD-treated group, Dr. Gordon reported. Specifically, the median survival was 108 weeks in the PLD arm versus 70 weeks for topotecan-treated patients (P =.017).
The curves "begin to diverge fairly early and maintain superiority for the patients treated with pegylated liposomal doxorubicin at time of initial relapse," he said.
"PLD is the only nonplatinum single agent to demonstrate a survival advantage [in these patients] and clearly should be the first nonplatinum agent of choice," Dr. Gordon said.
Johnson & Johnson Pharmaceutical Research & Development helped fund the study.
[Presentation title: Long-Term Survival Advantage for Recurrent Ovarian Cancer Patients Receiving Pegylated Liposomal Doxorubicin (PLD): Results of a Phase 3 Randomized Study. Abstract 32]
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