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培格非格司亭和每日粒细胞集落刺激因子:西班牙癌症患者的使用模式和中性粒细胞减少相关结局——LEARN 研究结果。

Pegfilgrastim and daily granulocyte colony-stimulating factor: patterns of use and neutropenia-related outcomes in cancer patients in Spain--results of the LEARN Study.

机构信息

Department of Oncology, Hospital Universitario Dr Peset, Valencia, Spain.

出版信息

Eur J Cancer Care (Engl). 2009 May;18(3):280-6. doi: 10.1111/j.1365-2354.2008.00959.x. Epub 2008 Dec 8.

Abstract

Daily granulocyte colony-stimulating factors [(G-CSFs); e.g. filgrastim, lenograstim] are frequently used to reduce the duration of chemotherapy-induced neutropenia (CIN) and the incidence of febrile neutropenia (FN) in cancer patients. A pegylated formulation of filgrastim, pegfilgrastim, which is administered once per cycle, was introduced in Spain in 2003. LEARN was a multi-centre, retrospective, observational study in Spain comparing patterns of use of daily G-CSF and pegfilgrastim, and CIN-related outcomes in adults with non-myeloid malignancies receiving myelosuppressive chemotherapy. Outcome measures were the percentage of patients receiving G-CSF for primary prophylaxis versus secondary prophylaxis/treatment, duration of treatment with G-CSF and incidence of CIN-related complications. Medical records from consecutive patients with documented pegfilgrastim (n = 75) or daily G-CSF (n = 111) use during 2003 were included. The proportion of patients receiving primary or secondary prophylaxis was comparable between the pegfilgrastim (39 and 48% respectively) and daily G-CSF (40 and 48% respectively) groups. However, there was a trend towards less frequent use to treat a neutropenic event such as FN or neutropenia in the pegfilgrastim group (17 versus 30% with daily G-CSF). Chemotherapy-induced neutropenia-related complications were less frequent in patients receiving pegfilgrastim (e.g. FN 11 versus 24% with daily G-CSF). This is the first study to show the potential benefits of pegfilgrastim over daily G-CSF in Spanish clinical practice.

摘要

每日粒细胞集落刺激因子[(G-CSF);例如非格司亭、培非格司亭]常用于减少癌症患者化疗引起的中性粒细胞减少症(CIN)的持续时间和发热性中性粒细胞减少症(FN)的发生率。一种聚乙二醇化的非格司亭制剂,培非格司亭,每周期给药一次,于 2003 年在西班牙推出。LEARN 是一项在西班牙进行的多中心、回顾性、观察性研究,比较了每日 G-CSF 和培非格司亭的使用模式,以及接受骨髓抑制化疗的非髓性恶性肿瘤成人的 CIN 相关结局。主要终点是接受 G-CSF 一级预防与二级预防/治疗的患者比例、G-CSF 治疗持续时间和 CIN 相关并发症发生率。纳入了 2003 年接受培非格司亭(n = 75)或每日 G-CSF(n = 111)治疗的患者的病历。培非格司亭(分别为 39%和 48%)和每日 G-CSF(分别为 40%和 48%)组接受一级或二级预防的患者比例相当。然而,培非格司亭组治疗 FN 或中性粒细胞减少等中性粒细胞减少事件的频率较低(17%比每日 G-CSF 组的 30%)。培非格司亭组的化疗相关中性粒细胞减少症相关并发症较少(如 FN 为 11%,每日 G-CSF 组为 24%)。这是第一项表明培非格司亭在西班牙临床实践中优于每日 G-CSF 的研究。

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