聚乙二醇脂质体阿霉素与托泊替康治疗复发难治性卵巢上皮癌患者的长期生存优势比较:3期随机研究

来源 :世界核心医学期刊文摘(妇产科学分册) | 被引量 : 0次 | 上传用户:mxhdb
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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. Provide long -term follow-up data fo r women treated in a randomized multicenter study of pegylated liposomal dox-orubicin compared with topotecan. Patients with epithelial ovarian cancer that recurred after or failed to respond to first liner platinum-based chemotherapy were randomized to receive pegylated liposomal doxoru bicin 50 mg / m 2 every 28 days (n = 239) or topotecan 1.5 mg / m 2 per day for 5 days every 21 days (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. Patients were already 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 62.7 weeks for pegylated liposomal doxorubicin and 59.7 weeks 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 (including those randomized, but never treated; n = 481) was 1.23 (median survival 63.6 weeks for pegylated liposomal For patients with platinum -sensitive dis-ease, there was a 30% reduction in the risk of death for the pegylated liposomal doxorubicin-t (95% CI 1.01-1.50; P = 0.038) reated group (median survival 107.9 weeks for pegylated l iposomal doxorubicin and 70.1 weeks for topotecan -treate d patients; HR = 1.432; 95% CI 1.066-1.923; P = 0.017) .In pa-tients with platinum- refractory diase, survival was similar between treatment groups. L ong -term follow-up demonstrates that treatment with 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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