生物类似物非格司亭治疗模式与发热性中性粒细胞减少症预防：法国一项针对实体瘤患者的前瞻性多中心研究（ZOHé 研究）。
Biosimilar filgrastim treatment patterns and prevention of febrile neutropenia: a prospective multicentre study in France in patients with solid tumours (the ZOHé study).
机构信息
Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse - Oncopole, 1 avenue Irène Joliot-Curie, 31059, Toulouse Cedex 9, France.
Institut Jean Godinot, Reims, France.
出版信息
BMC Cancer. 2018 Nov 16;18(1):1127. doi: 10.1186/s12885-018-4986-1.
BACKGROUND
The ZOHé study was a prospective, non-interventional, multicentre study in France to assess the use of biosimilar filgrastim Zarzio® (Sandoz filgrastim) in routine clinical practice in patients at risk of neutropenia-inducing chemotherapy (CT).
METHODS
Patients ≥ 18 years undergoing CT for a malignant disease and with a first prescription for Zarzio® were enrolled in two cohorts according to tumour type: solid tumour or haematological malignancy; results from the solid tumour cohort are reported here. Analyses primarily described the prescription and use of Zarzio® in current practice, and also included identification of factors linked to prescription for primary prophylaxis and comparison of Zarzio® use in relation to European Organisation for Research and Treatment of Cancer (EORTC) guidelines.
RESULTS
Responses were obtained from 125 physicians and 1179 patients with solid tumours, allowing robust statistical analysis of the data. Use of Zarzio® in clinical practice was relatively standardised and followed label indication. The patient profile was in line with EORTC guidelines for granulocyte colony-stimulating factor (G-CSF) febrile neutropenia (FN) prophylaxis, and the majority of patients had ≥ 1 EORTC factor(s) for increased risk of febrile neutropenia. Some patients (10.8%) received Zarzio® despite receiving CT regimens categorised in guidelines as low (< 10%) FN risk ('over prophylaxis'). Nearly half of patients' CT regimens did not have a recommended FN risk category. Zarzio® was commonly initiated as primary prophylaxis; initiation in Cycle ≥ 2 of the current line of CT was associated more with a history of neutropenia. The safety profile of Zarzio® was confirmed.
CONCLUSIONS
Use of Zarzio® in routine clinical practice is generally in line with EORTC guidelines for prophylaxis of CT-induced neutropenia. Patient-related risk factors appear to be a stronger driver of clinicians' decision to initiate Zarzio® than CT risk category for FN. The intrinsic risk of FN associated with a specific CT protocol is often miscategorised by physicians. In contrast to earlier reports of underuse of G-CSF prophylaxis, over prophylaxis is observed in a small subgroup of patients with FN risk of < 10%.
背景
ZOHé 研究是一项在法国进行的前瞻性、非干预性、多中心研究，旨在评估生物类似粒细胞集落刺激因子（Zarzio®，山德士）在接受致中性粒细胞减少化疗（CT）的高危患者的常规临床实践中的使用情况。
方法
年龄≥18 岁、因恶性疾病接受 CT 且首次处方 Zarzio®的患者根据肿瘤类型入组至两个队列：实体瘤或血液恶性肿瘤；本报告仅报告实体瘤队列的结果。分析主要描述了当前实践中 Zarzio®的处方和使用情况，还包括确定与预防性处方相关的因素，并比较了 Zarzio®的使用情况与欧洲癌症研究与治疗组织（EORTC）指南的关系。
结果
125 名医生和 1179 名实体瘤患者回复了问卷，允许对数据进行稳健的统计学分析。临床实践中 Zarzio®的使用相对标准化，符合标签指示。患者特征符合 EORTC 粒细胞集落刺激因子（G-CSF）预防发热性中性粒细胞减少症（FN）的指南，大多数患者有≥1 个 EORTC 因素（FN 风险增加）。一些患者（10.8%）尽管接受的 CT 方案在指南中被归类为 FN 风险较低（<10%），但仍接受 Zarzio®治疗（过度预防）。近一半的患者的 CT 方案没有推荐的 FN 风险类别。Zarzio®通常作为一线预防药物使用；在当前 CT 线的≥2 周期开始治疗与中性粒细胞减少症病史更相关。Zarzio®的安全性得到了证实。
结论
Zarzio®在常规临床实践中的使用通常符合 EORTC 指南预防 CT 诱导的中性粒细胞减少症。与 FN 风险类别相比，患者相关的危险因素似乎是临床医生决定开始使用 Zarzio®的更重要驱动因素。医生通常会错误地将与特定 CT 方案相关的 FN 固有风险归类。与早期报告的 G-CSF 预防不足相反，在 FN 风险<10%的一小部分患者中观察到过度预防。
Zotero 插件