Department of Medical Oncology, University Hospital Ghent, Ghent, Belgium.
Curr Med Res Opin. 2011 May;27(5):987-94. doi: 10.1185/03007995.2011.562493. Epub 2011 Mar 9.
To evaluate adherence to European Organisation for Research and Treatment of Cancer (EORTC) and European Summary of Product Characteristic (SmPC) guidance on recommended haemoglobin (Hb) values in routine clinical practice use of darbepoetin alfa (DA) in cancer patients internationally.
This multicentre, prospective, observational study assessed DA use in 11 European countries. This interim analysis (IA) included ∼1300 breast, colorectal, ovarian or lung cancer patients receiving DA during any chemotherapy cycle. Hb level and red blood cell (RBC) transfusion requirement data were collected.
Of the 1290 patients (mean [SD] age 62.5 [11.1] years) included in this IA full analysis set, 499 had lung, 387 breast, 192 colorectal and 212 ovarian cancer. Mean baseline Hb levels were <10 g/dL. At week 9, 426 (33%) patients had a Hb level of 10-12 g/dL, 165 (13%) of >12 g/dL, 226 (18%) of <10 g/dL and 473 (37%) had missing Hb values. 54% of the 672 patients still on the study at week 9 with available Hb values had Hb values of 10-12 g/dL. For patients with a baseline Hb of <10 g/dL, the Kaplan-Meier (K-M) percentage of patients with Hb levels ≥10 g/dL from week 1 to end of treatment period (EOTP) was 86%. For these patients, the K-M% of patients with Hb levels >13 g/dL from week 1 to EOTP was 10%. The K-M% of patients requiring RBC transfusions from week 5 to EOTP was 26% for all patients. Seven patients reported treatment-related non-serious adverse drug reactions, four were thromboses.
This IA suggests most patients were treated according to European SmPC guidance. Hb evolution during the study is consistent with data from clinical trials, implying DA is effective in increasing Hb levels in chemotherapy-induced anaemia patients. Hb levels >13 g/dL were infrequent. Limitations are related to the observational nature of this study.
评估欧洲癌症研究与治疗组织（EORTC）和欧洲产品特性摘要（SmPC）关于在国际上癌症患者常规临床实践中使用达贝泊汀的推荐血红蛋白（Hb）值的指南的依从性。
这是一项多中心、前瞻性、观察性研究，评估了 11 个欧洲国家的达贝泊汀的使用情况。该中期分析（IA）包括约 1300 名接受任何化疗周期达贝泊汀治疗的乳腺癌、结直肠癌、卵巢癌或肺癌患者。收集 Hb 水平和红细胞（RBC）输血需求数据。
在本次 IA 的全分析集（FAS）中，纳入了 1290 名患者（平均[标准差]年龄 62.5[11.1]岁），其中 499 名为肺癌患者，387 名为乳腺癌患者，192 名为结直肠癌患者，212 名为卵巢癌患者。平均基线 Hb 水平＜10g/dL。在第 9 周时，426（33%）名患者的 Hb 水平为 10-12g/dL，165（13%）名患者的 Hb 水平＞12g/dL，226（18%）名患者的 Hb 水平＜10g/dL，473（37%）名患者的 Hb 水平缺失。在第 9 周时，672 名仍在研究中的可提供 Hb 值的患者中，有 54%的 Hb 值为 10-12g/dL。对于基线 Hb＜10g/dL 的患者，从第 1 周到治疗结束期（EOTP），Hb 水平≥10g/dL 的患者的 Kaplan-Meier（K-M）百分比为 86%。对于这些患者，从第 1 周到 EOTP，Hb 水平＞13g/dL 的患者的 K-M%为 10%。从第 5 周到 EOTP，所有患者需要 RBC 输血的 K-M%为 26%。7 名患者报告了与治疗相关的非严重药物不良反应，其中 4 名是血栓形成。
本次 IA 表明，大多数患者的治疗符合欧洲 SmPC 指南。研究期间的 Hb 演变与临床试验数据一致，这意味着达贝泊汀可有效提高化疗诱导性贫血患者的 Hb 水平。Hb 水平＞13g/dL 较为少见。该研究的局限性在于其观察性性质。
