de Castro Javier, Ordóñez Amalio, Isla Dolores, Sánchez Alfredo, Arrivi Antonio, Manzano José Luis, Barón Manuel González
Servicio de Oncología Médica, Hospital Universitario La Paz (Madrid), Paseo de la Castellana, 261, 28046, Madrid, Spain.
Cancer Chemother Pharmacol. 2007 Jan;59(1):35-42. doi: 10.1007/s00280-006-0251-4. Epub 2006 Jul 28.
Anaemia is common during platinum-based chemotherapy. This study aimed to evaluate the efficacy and safety of epoetin beta in the prevention of severe anaemia in patients with solid tumours receiving concomitant platinum therapy.
In this open-label, single-arm study, patients (n = 255) with solid tumours and haemoglobin (Hb) levels </= 13 g/dl (men) or </= 12 g/dl (women) received epoetin beta 450 IU/kg ( approximately 30,000 IU) weekly until 4 weeks after their last platinum-based chemotherapy cycle.
An anaemia prevention response [defined as patients with a Hb response (increase in Hb level > 1 g/dl from baseline) plus patients whose Hb levels remained +/- 1 g/dl of baseline throughout the study] was observed in 234 patients (92%). Response to epoetin beta was rapid. Of the 159 patients achieving a Hb response, 139 (87%) had Hb levels > 1 g/dl of baseline within 4 weeks of treatment initiation. Mean Hb levels had improved from 10.8 +/- 1.0 g/dl at baseline to 12.2 +/- 1.8 g/dl by the final visit. Quality of life measured by linear analogue scale assessment significantly (P < 0.01) improved in patients achieving a Hb response (n = 159).
Epoetin beta effectively prevents anaemia in most patients with solid tumours receiving concurrent platinum-based chemotherapy.
在铂类化疗期间贫血很常见。本研究旨在评估β-促红细胞生成素预防接受铂类联合治疗的实体瘤患者严重贫血的疗效和安全性。
在这项开放标签、单臂研究中，实体瘤患者（n = 255），血红蛋白（Hb）水平男性≤13 g/dl或女性≤12 g/dl，每周接受450 IU/kg（约30,000 IU）的β-促红细胞生成素，直至最后一个铂类化疗周期后4周。
234例患者（92%）观察到贫血预防反应[定义为Hb有反应的患者（Hb水平较基线升高>1 g/dl）加上在整个研究过程中Hb水平维持在基线±1 g/dl的患者]。对β-促红细胞生成素的反应迅速。在159例Hb有反应的患者中，139例（87%）在开始治疗后4周内Hb水平高于基线1 g/dl。末次访视时平均Hb水平从基线时的10.8±1.0 g/dl提高到12.2±1.8 g/dl。通过线性模拟量表评估测量的生活质量在Hb有反应的患者（n = 159）中显著（P < 0.01）改善。
β-促红细胞生成素能有效预防大多数接受铂类同步化疗的实体瘤患者的贫血。
