Department of Medical Oncology, University Hospital Ghent, Ghent, Belgium.
Curr Med Res Opin. 2012 Jul;28(7):1079-87. doi: 10.1185/03007995.2012.698601. Epub 2012 Jun 21.
The CHOICE study was a prospective, multicentre, observational study designed to assess the level of adherence in current clinical practice to the European product label and the EORTC guidelines for the treatment of chemotherapy-induced anaemia with darbepoetin alfa (DA).
Hb levels and red blood cell (RBC) transfusion requirements were evaluated among 1900 patients with solid tumours in 11 European countries. The primary outcome measure was the proportion of patients with a target Hb level of ≥10-≤12 g/dL after 9 weeks' DA treatment.
The full analysis set (FAS) comprised 1887 patients (mean ± SD age 62.4 ± 11.4 years) divided into categories by baseline Hb < 9 g/dL (n = 281); 9-<10 g/dL (n = 770); 10-<11 g/dL (n = 695); ≥11 g/dL (n = 114). The proportion of patients who remained on the study at week 9 achieving the target Hb level was 37% (n = 60), 48% (n = 217), 54% (n = 210) and 38% (n = 23) in the subgroups with a baseline Hb level of <9 g/dL, 9-<10 g/dL, 10-<11 g/dL and ≥11 g/dL, respectively. In the <9 g/dL, 9-<10 g/dL, 10-<11 g/dL and ≥11 g/dL subgroups of the FAS, the number of patients maintaining Hb levels ≥10 g/dL after their first achievement of an Hb value of 10 g/dL was 95 (34%), 372 (48%), 476 (68%) and 87 (76%), respectively. The Kaplan-Meier percentages of patients who required an RBC transfusion from week 5 until end of treatment period were: 29%, 20%, 12% and 17% in the <9 g/dL, 9-<10 g/dL, 10-<11 g/dL and ≥11 g/dL subgroups, respectively. Kaplan-Meier percentages of patients reaching an Hb level of >13 g/dL were 10%, 9%, 21% and 29%, respectively. Potential bias could not be excluded due to the study's observational nature.
DA initiation and target Hb ranges adhered to current guidelines in the majority of patients. Furthermore, this study demonstrates faster achievement of the target range and reduced transfusion requirements are associated with initiation of DA at Hb levels of 9-<10 g/dL and 10-<11 g/dL rather than <9 g/dL.
CHOICE 研究是一项前瞻性、多中心、观察性研究，旨在评估当前临床实践中对欧洲产品标签和 EORTC 指南的遵循程度，这些指南用于治疗化疗引起的贫血，使用的药物是达贝泊汀 α（DA）。
在 11 个欧洲国家的 1900 名实体瘤患者中评估了血红蛋白（Hb）水平和红细胞（RBC）输血需求。主要观察指标为接受 9 周 DA 治疗后达到目标 Hb 水平（≥10-≤12g/dL）的患者比例。
全分析集（FAS）包括 1887 名患者（平均年龄 62.4±11.4 岁），根据基线 Hb<9g/dL（n=281）、9-<10g/dL（n=770）、10-<11g/dL（n=695）、≥11g/dL（n=114）进行分类。在第 9 周仍留在研究中的患者中，达到目标 Hb 水平的比例分别为 37%（n=60）、48%（n=217）、54%（n=210）和 38%（n=23），分别处于基线 Hb 水平<9g/dL、9-<10g/dL、10-<11g/dL和≥11g/dL亚组。在<9g/dL、9-<10g/dL、10-<11g/dL和≥11g/dL亚组中，首次达到 Hb 水平 10g/dL后维持 Hb 水平≥10g/dL的患者数量分别为 95（34%）、372（48%）、476（68%）和 87（76%）。从第 5 周到治疗结束，需要输血的患者的 Kaplan-Meier 百分比分别为：<9g/dL、9-<10g/dL、10-<11g/dL和≥11g/dL亚组中的 29%、20%、12%和 17%。达到 Hb 水平>13g/dL 的 Kaplan-Meier 百分比分别为 10%、9%、21%和 29%。由于研究的观察性质，不能排除潜在的偏倚。
在大多数患者中，DA 的起始和目标 Hb 范围符合当前指南。此外，本研究表明，更快地达到目标范围和减少输血需求与在 Hb 水平为 9-<10g/dL 和 10-<11g/dL 时而不是<9g/dL 时开始使用 DA 相关。
