Spaëth Dominique, Desablens Bernard, Rodon Philippe, Mennecier Bertrand, Oudard Stéphane, Moullet Isabelle, Ghomari Kamel, Bergougnoux Loïc, Bleuzen Pascal, Jenabian Arash, Ifrah Norbert
Centre d'Oncologie de Gentilly, Nancy, France.
Oncology. 2008;74(1-2):112-8. doi: 10.1159/000139139. Epub 2008 Jun 12.
This study aimed to provide further clinical evidence for the efficacy and safety of epoetin beta once weekly across a wide range of cancer types.
This was a multicenter, open-label, prospective, single-arm study in patients with either a solid tumor or non-myeloid hematological malignancy, receiving or scheduled to receive further chemotherapy. Patients received epoetin beta 30,000 IU subcutaneously once weekly for 16 weeks. The primary efficacy endpoint was the change in hemoglobin (Hb) level according to the patient's baseline Hb level.
A total of 691 patients were included in the intent-to-treat population. Epoetin beta effectively increased Hb levels (a mean increase from baseline of 1.1 g/dl by week 4 and 2.2 g/dl by week 12). Hb response was achieved in 60.4% of all patients and 61.2% of those with baseline Hb <11 g/dl. Hb response was similar in patients with solid tumors (60.5%) and non-myeloid hematological malignancies (60.2%). Type of chemotherapy and baseline platelet count were independent predictive factors for response. Epoetin beta treatment was well tolerated.
Epoetin beta 30,000 IU once weekly effectively increases Hb levels, is well tolerated and has similar efficacy in anemic patients with solid tumors or non-myeloid hematological malignancies.
本研究旨在为β-促红细胞生成素每周一次在多种癌症类型中的疗效和安全性提供进一步的临床证据。
这是一项多中心、开放标签、前瞻性、单臂研究，纳入实体瘤或非髓系血液系统恶性肿瘤患者，这些患者正在接受或计划接受进一步化疗。患者每周皮下注射一次30,000 IU的β-促红细胞生成素，共16周。主要疗效终点是根据患者基线血红蛋白（Hb）水平计算的Hb水平变化。
意向性治疗人群共纳入691例患者。β-促红细胞生成素有效提高了Hb水平（第4周时Hb水平较基线平均升高1.1 g/dl，第12周时升高2.2 g/dl）。所有患者中有60.4%达到Hb反应，基线Hb<11 g/dl的患者中有61.2%达到Hb反应。实体瘤患者（60.5%）和非髓系血液系统恶性肿瘤患者（60.2%）的Hb反应相似。化疗类型和基线血小板计数是反应的独立预测因素。β-促红细胞生成素治疗耐受性良好。
每周一次30,000 IU的β-促红细胞生成素可有效提高Hb水平，耐受性良好，在实体瘤或非髓系血液系统恶性肿瘤贫血患者中具有相似的疗效。
