Provide long -term follow -up data fo r women treated in a randomized multicenter study of pegylated liposomal dox-orubicin compared with topotecan.P atients with epithelial ovarian cancer that recurred after o r failed to respond to firstline platinum -based chemotherapy were randomized to receive pegylated liposomal doxoru bicin 50mg /m 2 every28days(n =239)or topotecan 1.5mg /m 2 per day for 5days every 21days(n =235).Patients were stratified prospectively based on response to i nitial platinum -based chemotherapy as well as the presence or absence of bulky disease.Most patients had been previously treated with platinum and taxanes(74%in the pegylated liposomal doxorubicin group and 72%in the topotecan group).Survival data are mature:87%of patients have died(n =413).There was an 18%reduction in the ris k of death for patients treated with pegy lated liposomal doxoru-bicin(median survival 62.7weeks for pegylated liposomal doxorubicin and 59.7weeks for topotecan -treated pa-tients;HR =1.216;95%confidence in terval(CI )1.000-1.478;P =0.050).The hazard ratio for all randomized subjects(includes those randomized,but never treated;n =481)was 1.23(median survival 63.6weeks for pegylated liposomal doxorubicin and 57.0weeks for topotecan -treated patients;95%CI 1.01-1.50;P =0.038).For patients with platinum -sensitive dis-ease,there was a 30%reduction in the risk of death for the pegylated liposomal doxorubicin -t reated group(median survival 107.9weeks for pegylated l iposomal doxorubicin and 70.1weeks for topotecan -treate d patients;HR =1.432;95%CI 1.066-1.923;P =0.017).In pa-tients with platinum -refractory di sease,survival was similar between treatment groups.L ong -term follow -up demonstrates that treatmentwith pegylated liposomal dox-orubicin significantly prolongs su rvival compared with topotecan in patients with recurren t and refractory epithelial ovarian cancer.The survival benefi t is pronounced in pa-tients with platinumsensitive dise ase.
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