Global Research & Development, Amgen Inc., Thousand Oaks, CA, USA.
Global Medical Affairs, Amgen Inc., Thousand Oaks, CA, USA.
Curr Med Res Opin. 2023 May;39(5):707-718. doi: 10.1080/03007995.2023.2196197. Epub 2023 Apr 8.
Chemotherapy-induced febrile neutropenia (FN) is a medical emergency that may occur in patients with malignancies receiving myelosuppressive chemotherapy. FN requires early therapeutic intervention since it is associated with increased hospitalizations and high mortality risk of 5%-20%. FN-related hospitalizations are higher in patients with myeloid malignancies than in those with solid tumors due to the myelotoxicity of chemotherapy regimens and the compromised bone marrow function. FN increases the burden of cancer by causing chemotherapy dose reductions and delays. The administration of the first granulocyte colony-stimulating factor (G-CSF) filgrastim reduced the incidence and duration of FN in patients undergoing chemotherapy. Filgrastim later evolved into pegfilgrastim, which has a longer half-life than filgrastim and is associated with a lower rate of severe neutropenia, chemotherapy dose reduction, and treatment delay. Nine million patients have received pegfilgrastim since its approval in early 2002. The pegfilgrastim on-body injector (OBI) is an innovative device facilitating the time-released auto-injection of pegfilgrastim approximately 27 h after chemotherapy, as clinically recommended for the prevention of FN, thus eliminating the need for a next-day hospital visit. Since its introduction in 2015, one million patients with cancer have received pegfilgrastim using the OBI. Subsequently, the device was approved in the United States (US), European Union, Latin America, and Japan, with studies and a postmarketing commitment demonstrating device reliability. A recent prospective observational study conducted in the US demonstrated that the OBI substantially improved the adherence to and compliance with clinically recommended pegfilgrastim therapy; patients receiving pegfilgrastim the OBI experienced a lower incidence of FN than those receiving alternatives for FN prophylaxis. This review discusses the evolution of G-CSFs leading to the development of the OBI, current recommendations for G-CSF prophylaxis in the clinic, continued evidence supporting next-day pegfilgrastim administration, and improvements in patient care made possible with the OBI.
化疗引起的发热性中性粒细胞减少症（FN）是一种医疗急症，可能发生在接受骨髓抑制化疗的恶性肿瘤患者中。FN 需要早期治疗干预，因为它与住院率增加和 5%-20%的高死亡率相关。由于化疗方案的骨髓毒性和骨髓功能受损，髓样恶性肿瘤患者的 FN 相关住院率高于实体瘤患者。FN 通过导致化疗剂量减少和延迟，增加了癌症负担。粒细胞集落刺激因子（G-CSF）的首次给药，如非格司亭，降低了接受化疗患者 FN 的发生率和持续时间。非格司亭后来演变为培非格司亭，其半衰期长于非格司亭，与严重中性粒细胞减少症、化疗剂量减少和治疗延迟的发生率较低相关。自 2002 年初批准以来，已有 900 万名患者接受了培非格司亭治疗。培非格司亭体部注射剂（OBI）是一种创新装置，可在临床推荐预防 FN 时，大约在化疗后 27 小时进行时间释放自动注射培非格司亭，从而消除次日住院的需要。自 2015 年推出以来，已有 100 万名癌症患者使用 OBI 接受了培非格司亭治疗。随后，该设备在美国、欧盟、拉丁美洲和日本获得批准，研究和上市后承诺证明了设备的可靠性。最近在美国进行的一项前瞻性观察性研究表明，OBI 极大地提高了临床推荐的培非格司亭治疗的依从性和顺应性；接受 OBI 治疗的患者 FN 发生率低于接受其他 FN 预防方案的患者。本文讨论了 G-CSF 的发展导致 OBI 的开发，目前临床 G-CSF 预防的建议，支持次日给予培非格司亭的持续证据，以及 OBI 带来的患者护理改善。
