Division of Medical Oncology, Department of Hematology-Oncology, Hospital Clínic de Barcelona, University of Barcelona, Spain.
Crit Rev Oncol Hematol. 2011 Mar;77(3):198-200. doi: 10.1016/j.critrevonc.2011.01.006.
The MONITOR-GCSF study is an international, prospective, observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the use of biosimilar filgrastim in the prophylaxis of febrile neutropenia in chemotherapy-treated cancer patients. The background and methodology of this study are described in an article published concurrently in this journal. As important amendments have been made to the protocol, and the purpose of the prior article was to serve as a resource for future referencing, we detail these amendments in this present article: explicit statement about the use of biosimilar filgrastim for both primary and secondary prophylaxis of chemotherapy-induced febrile neutropenia in the objectives and methodology of the study; length of observation; the addition of stage III and stage IV ovarian cancer and multiple myeloma to the tumor types studied; and the deletion of dose dense chemotherapy regimens as an exclusion criterion.
MONITOR-GCSF 研究是一项国际性、前瞻性、观察性、药物流行病学研究，旨在评估与生物类似粒细胞集落刺激因子在化疗治疗癌症患者预防发热性中性粒细胞减少症中的使用相关的多层次因素和结局。该研究的背景和方法在同期发表在本杂志上的一篇文章中进行了描述。由于方案有重要修订，且之前的文章旨在作为未来参考的资源，因此我们在本文中详细介绍这些修订：在研究的目的和方法中明确提出使用生物类似粒细胞集落刺激因子进行化疗引起的发热性中性粒细胞减少症的一级和二级预防；观察时间长度；将 III 期和 IV 期卵巢癌和多发性骨髓瘤添加到研究的肿瘤类型中；以及删除剂量密集化疗方案作为排除标准。
