Comparative Outcomes Group, Bristol, UK.
Department of Hematology-Oncology, University of Barcelona, Barcelona, Spain.
BioDrugs. 2020 Jun;34(3):255-263. doi: 10.1007/s40259-020-00411-4.
Febrile neutropenia (FN) is a serious complication of chemotherapy, which can cause significant morbidity and mortality, result in dose delays and reductions and, ultimately, reduce cancer survival. Over the past decade, the availability of biosimilar filgrastim (short-acting granulocyte colony-stimulating factor [G-CSF]) has transformed patient access, with clear evidence of clinical benefit at preventing FN at reduced costs. In 2019, seven biosimilar pegfilgrastims (long-acting G-CSFs) were licensed, creating optimal market conditions and choice for prescribers. FN affects up to 117 per 1000 cancer patients, with mortality rates in the range of 2-21%. By reducing FN incidence and improving chemotherapy relative dose intensity (RDI), G-CSF has been associated with a 3.2% absolute survival benefit. Guidelines recommend primary prophylaxis and that filgrastim be administered for 10-14 days, while pegfilgrastim is administered once per cycle. When taken according to the guidelines, pegfilgrastim and filgrastim are equally effective. However, in routine clinical practice, filgrastim is often under-dosed (< 7 days) and has been shown to be inferior to pegfilgrastim at reducing FN incidence, hospitalisations and maintaining RDI. Once-per-cycle administration with pegfilgrastim might also aid patient adherence. The introduction of biosimilar pegfilgrastim should instigate a rethink of neutropenia management. Biosimilar pegfilgrastim offers countries using biosimilar filgrastim opportunities to improve adherence and thus cancer survival, whilst offering economic benefits for countries using reference pegfilgrastim. These benefits can be realised in full if biosimilar pegfilgrastim becomes part of routine clinical practice supported by drug and therapeutic committees implementing guidelines with multidisciplinary support in the hospital.
发热性中性粒细胞减少症(FN)是化疗的一种严重并发症,可导致严重的发病率和死亡率,导致剂量延迟和减少,并最终降低癌症生存率。在过去的十年中,生物类似物非格司亭(短效粒细胞集落刺激因子[G-CSF])的出现改变了患者的可及性,具有降低成本预防 FN 的临床获益的明确证据。2019 年,七种生物类似物培非格司亭(长效 G-CSF)获得批准,为医生提供了最佳的市场条件和选择。FN 影响多达每 1000 名癌症患者 117 例,死亡率在 2-21%之间。通过降低 FN 的发生率和提高化疗相对剂量强度(RDI),G-CSF 与 3.2%的绝对生存获益相关。指南建议进行一级预防,并且应给予 10-14 天的非格司亭治疗,而培非格司亭则每周期给予一次。按照指南使用时,培非格司亭和非格司亭同样有效。然而,在常规临床实践中,非格司亭常常剂量不足(<7 天),并且已显示在降低 FN 的发生率、住院率和维持 RDI 方面劣于培非格司亭。培非格司亭的每周期一次给药也可能有助于提高患者的依从性。生物类似物培非格司亭的引入应促使重新思考中性粒细胞减少症的管理。生物类似物培非格司亭为使用生物类似物非格司亭的国家提供了改善依从性从而提高癌症生存率的机会,同时为使用参考培非格司汀的国家提供了经济效益。如果生物类似物培非格司亭成为常规临床实践的一部分,并在医院中得到药物和治疗委员会的支持,以及多学科支持来实施指南,这些益处就可以得到充分实现。