Abstract：
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 via 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.
For over 20 years, treatment with pegfilgrastim (a therapy that supports the growth of immune cells) has been used in patients with cancer to prevent febrile neutropenia (FN) – an unwanted effect of cancer treatment or chemotherapy. FN is defined as the loss of healthy immune cells and development of fever possibly due to an infection. Patients with FN may be very ill or may die, depending on the seriousness of the condition. However, treatment with pegfilgrastim reduces the occurrence of FN and improves survival.Treatment guidelines recommend that pegfilgrastim should be given 24 h after chemotherapy, requiring patients to travel to the hospital on the next day of chemotherapy. Some patients may choose the less helpful option of receiving pegfilgrastim on the same day of chemotherapy to avoid travel. This need led to the development of an on-body injector (OBI) device that is applied on the skin on the last day of chemotherapy and administers pegfilgrastim approximately 27 h after chemotherapy. The highly reliable OBI ensures timely delivery of therapy with a success rate of 99.9%, reduces the travel burden, and helps in following the recommended guidelines for pegfilgrastim administration. For two decades, pegfilgrastim has played a significant role in the treatment and prevention of FN, and the new OBI device provides the required treatment support for improving patient care.
For over 20 years, treatment with pegfilgrastim (a therapy that supports the growth of immune cells) has been used in patients with cancer to prevent febrile neutropenia (FN) – an unwanted effect of cancer treatment or chemotherapy. FN is defined as the loss of healthy immune cells and development of fever possibly due to an infection. Patients with FN may be very ill or may die, depending on the seriousness of the condition. However, treatment with pegfilgrastim reduces the occurrence of FN and improves survival.Treatment guidelines recommend that pegfilgrastim should be given 24 h after chemotherapy, requiring patients to travel to the hospital on the next day of chemotherapy. Some patients may choose the less helpful option of receiving pegfilgrastim on the same day of chemotherapy to avoid travel. This need led to the development of an on-body injector (OBI) device that is applied on the skin on the last day of chemotherapy and administers pegfilgrastim approximately 27 h after chemotherapy. The highly reliable OBI ensures timely delivery of therapy with a success rate of 99.9%, reduces the travel burden, and helps in following the recommended guidelines for pegfilgrastim administration. For two decades, pegfilgrastim has played a significant role in the treatment and prevention of FN, and the new OBI device provides the required treatment support for improving patient care.
摘要：
化疗引起的发热性中性粒细胞减少症（FN）是一种医疗紧急情况，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％的高死亡风险相关。由于化疗方案的骨髓毒性和骨髓功能受损，骨髓性恶性肿瘤患者的FN相关住院率高于实体瘤患者。FN通过引起化疗剂量减少和延迟而增加癌症的负担。在接受化疗的患者中，首次使用粒细胞集落刺激因子（G-CSF）非格司亭可降低FN的发生率和持续时间。Filgrastim后来演变成pegfilgrastim，比非格司亭具有更长的半衰期，并且与较低的严重中性粒细胞减少症相关，化疗剂量减少，治疗延迟。自2002年初批准以来，已有900万患者接受了pegfilgrastim。pegfilgrastim体内注射器（OBI）是一种创新的设备，可在化疗后约27小时内自动注射pegfilgrastim。根据临床推荐的预防FN，从而消除了第二天去医院的需要。自2015年推出以来，已有100万癌症患者使用OBI接受了pegfilgrastim。随后，该设备已在美国（US）获得批准，欧洲联盟,拉丁美洲,和日本,通过研究和上市后承诺证明设备的可靠性。最近在美国进行的一项前瞻性观察性研究表明，OBI大大改善了临床推荐的pegfilgrastim治疗的依从性和依从性；通过OBI接受pegfilgrastim的患者的FN发生率低于接受FN预防替代方案的患者。这篇综述讨论了导致OBI发展的G-CSF的演变，目前在临床上预防G-CSF的建议，继续有证据支持第二天的pegfilgrastim管理，OBI使患者护理的改善成为可能。
20多年来,pegfilgrastim（一种支持免疫细胞生长的疗法）已用于癌症患者，以预防发热性中性粒细胞减少症（FN）-癌症治疗或化疗的不良作用。FN被定义为健康免疫细胞的损失和可能由于感染引起的发烧的发展。FN患者可能病重或死亡,取决于病情的严重性。然而,pegfilgrastim治疗可减少FN的发生并提高生存率。治疗指南建议化疗后24小时给予pegfilgrastim，要求患者在化疗的第二天前往医院。一些患者可能会选择在化疗的同一天接受pegfilgrastim，以避免旅行。这种需求导致了体内注射器（OBI）设备的开发，该设备在化疗的最后一天应用于皮肤上，并在化疗后约27小时施用pegfilgrastim。高度可靠的OBI确保及时提供治疗，成功率为99.9％，减轻旅行负担，并有助于遵循pegfilgrastim管理的建议指南。二十年来,pegfilgrastim在FN的治疗和预防中发挥了重要作用，新的OBI设备为改善患者护理提供了所需的治疗支持。
20多年来,pegfilgrastim（一种支持免疫细胞生长的疗法）已用于癌症患者，以预防发热性中性粒细胞减少症（FN）-癌症治疗或化疗的不良作用。FN被定义为健康免疫细胞的损失和可能由于感染引起的发烧的发展。FN患者可能病重或死亡,取决于病情的严重性。然而,pegfilgrastim治疗可减少FN的发生并提高生存率。治疗指南建议化疗后24小时给予pegfilgrastim，要求患者在化疗的第二天前往医院。一些患者可能会选择在化疗的同一天接受pegfilgrastim，以避免旅行。这种需求导致了体内注射器（OBI）设备的开发，该设备在化疗的最后一天应用于皮肤上，并在化疗后约27小时施用pegfilgrastim。高度可靠的OBI确保及时提供治疗，成功率为99.9％，减轻旅行负担，并有助于遵循pegfilgrastim管理的建议指南。二十年来,pegfilgrastim在FN的治疗和预防中发挥了重要作用，新的OBI设备为改善患者护理提供了所需的治疗支持。
