Phase III, randomized study of the effects of parenteral iron, oral iron, or no iron supplementation on the erythropoietic response to darbepoetin alfa for patients with chemotherapy-associated anemia.
Phase III, randomized study of the effects of parenteral iron, oral iron, or no iron supplementation on the erythropoietic response to darbepoetin alfa for patients with chemotherapy-associated anemia.
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DOI：
10.1200/jco.2010.30.3644
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发表时间：
2011
期刊：
影响因子：
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通讯作者：
D. Steensma;J. Sloan;S. Dakhil;R. Dalton;S. Kahanic;D. Prager;P. Stella;K. Rowland;P. Novotny;C. Loprinzi
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文献类型：
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作者：
D. Steensma;J. Sloan;S. Dakhil;R. Dalton;S. Kahanic;D. Prager;P. Stella;K. Rowland;P. Novotny;C. Loprinzi
目的：功能性铁缺乏可能损害化疗相关性贫血（CAA）患者对促红细胞生成素（esa）的反应。本研究评估肠外铁联合给药是否能提高CAA患者的ESA疗效。患者和方法：这项前瞻性、多中心、随机试验纳入了502例血红蛋白（Hb）低于11 g/dL的非髓系恶性肿瘤化疗患者。所有患者每3周接受一次达贝泊汀治疗，随机分配每3周静脉注射葡萄糖酸铁187.5 mg，每天口服硫酸亚铁325 mg，或口服安慰剂16周。结果：两组患者的促红细胞生成反应率（即达到Hb≥12 g/dL或Hb较基线增加≥2 g/dL的患者比例）无差异：69.5% （95% CI, 61.9% - 76.5%）的IV铁治疗患者达到了促红细胞生成反应，而口服铁治疗组为66.9% (95% CI, 59.1% - 74.0%)，口服安慰剂组为65.0% (95% CI, 57.2% - 72.3%) （P = 0.75）。在需要红细胞输注的患者比例、生活质量的改变或给药达贝泊丁的剂量方面也没有差异。不良事件（ae）在静脉铁治疗组更常见：静脉铁治疗组中54% （95% CI, 46% - 61%）的患者发生了3级或以上的ae，而口服铁治疗组为44% (95% CI, 36% - 52%)，口服安慰剂治疗组为46% (95% CI, 38% - 54%) （P = 0.16）。结论：在CAA患者中，与口服铁或口服安慰剂相比，静脉滴注葡萄糖酸铁不能提供额外的益处。
PURPOSE Functional iron deficiency may impair response to erythropoiesis-stimulating agents (ESAs) in iron-replete patients with chemotherapy-associated anemia (CAA). This study evaluated whether coadministration of parenteral iron improves ESA efficacy in patients with CAA. PATIENTS AND METHODS This prospective, multicenter, randomized trial enrolled 502 patients with hemoglobin (Hb) less than 11 g/dL who were undergoing chemotherapy for nonmyeloid malignancies. All patients received darbepoetin alfa once every 3 weeks and were randomly assigned to receive either ferric gluconate 187.5 mg intravenously (IV) every 3 weeks, oral daily ferrous sulfate 325 mg, or oral placebo for 16 weeks. RESULTS There was no difference in the erythropoietic response rate (ie, proportion of patients achieving Hb ≥ 12 g/dL or Hb increase ≥ 2 g/dL from baseline): 69.5% (95% CI, 61.9% to 76.5%) of IV iron-treated patients achieved an erythropoietic response compared with 66.9% (95% CI, 59.1% to 74.0%) who received oral iron and 65.0% (95% CI, 57.2% to 72.3%) who received oral placebo (P = .75). There were also no differences in the proportion of patients requiring red cell transfusions, changes in quality of life, or the dose of darbepoetin administered. Adverse events (AEs) tended to be more common in the IV iron arm: grade 3 or higher AEs occurred in 54% (95% CI, 46% to 61%) of patients receiving IV iron compared with 44% (95% CI, 36% to 52%) who received oral iron and 46% (95% CI, 38% to 54%) who received oral placebo (P = .16). CONCLUSION In patients with CAA, addition of IV ferric gluconate to darbepoetin failed to provide additional benefit compared with oral iron or oral placebo.