Safety and efficacy outcomes with erythropoiesis-stimulating agents in patients with breast cancer: a meta-analysis

Safety and efficacy outcomes with erythropoiesis-stimulating agents in patients with breast cancer: a meta-analysis
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DOI:
10.1093/annonc/mdu579
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发表时间:
2015-04-01
期刊:
影响因子:
50.5
通讯作者:
Leyland-Jones, B.
Leyland-Jones, B.
中科院分区:
医学1区
文献类型:
--
作者:
Aapro, M.;Moebus, V.;Leyland-Jones, B.

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背景:在一项使用促红细胞生成素(epoetin α, epoetin β, darbepoetin α,生物类似药)的对照试验的荟萃分析中,提出了促红细胞生成素(ESA)与接受化疗的乳腺癌患者的总生存期和疾病进展相关结局的新数据。患者和方法:文献检索确定了1997年1月至2014年3月的报告。我们使用Amgen, Inc.或Janssen研究的公司数据库,并发表其他研究的数据。计算随机效应优势比(ORs)来比较随机分到ESA组的患者和随机分到对照组的患者的结果。结果:ESA组2346例患者中有571例(24%)死亡,对照组2367例患者中有523例(22%)死亡[OR, 1.20;95%置信区间(CI) 1.03-1.40]。进行敏感性分析以探讨个别研究的影响,排除一项研究(BEST)导致死亡的OR为1.12 (95% CI 0.94-1.34)。在7项报告进展相关终点的研究中(N = 4197; ESA N = 2088;对照N = 2109), ESA与对照的OR为1.01 (95% CI 0.87-1.16)。结论:在合并了ESA在乳腺癌患者中使用的最新结果后,生存风险和无进展生存与先前发表的数据保持一致。
Background: New data on erythropoiesis-stimulating agents (ESAs) regarding overall survival and disease progression-related outcomes in patients with breast cancer receiving chemotherapy are presented in a meta-analysis of controlled trials of ESA use (epoetin alpha, epoetin beta, darbepoetin alpha, biosimilars).Patients and methods: A literature search identified reports from January 1997 through March 2014. We used company databases for Amgen, Inc., or Janssen studies and published data for other studies. Random-effects odds ratios (ORs) were calculated to compare results for patients randomized to ESA with those randomized to control.Results: Deaths were reported for 571 of 2346 patients (24%) in the ESA groups and 523 of 2367 patients (22%) in the control groups [OR, 1.20; 95% confidence interval (CI) 1.03-1.40]. Sensitivity analyses were conducted to explore the effects of individual studies and exclusion of one study (BEST) resulted in an OR for death of 1.12 (95% CI 0.94-1.34). In seven studies reporting progression-related end points (N = 4197; ESA n = 2088; control n = 2109), the OR was 1.01 (95% CI 0.87-1.16) for ESA compared with control.Conclusions: After incorporating recent results of ESA use in patients with breast cancer, risks of survival and progression-free survival remain consistent with previously published data.