Frampton James E, Keating Gillian M
Adis International Inc., 770 Township Line Road, Suite 300, Yardley, Pennsylvania 19067, USA.
BioDrugs. 2005;19(6):405-7. doi: 10.2165/00063030-200519060-00008.
Pegfilgrastim (Neulasta), the sustained-duration form of filgrastim (recombinant human granulocyte colony-stimulating factor [G-CSF]), is created by the addition of a polyethylene glycol (PEG) moiety to filgrastim. Its approved indication in the US is to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy.A single subcutaneous injection of pegfilgrastim once per chemotherapy cycle was more effective than placebo as an adjunct to moderately myelosuppressive chemotherapy for breast cancer, no less effective than daily injections of filgrastim as an adjunct to highly myelosuppressive chemotherapy for breast cancer, and as effective as daily filgrastim as an adjunct to chemotherapy for lymphoma (predominantly non-Hodgkin lymphoma [NHL]) and acute myeloid leukemia. Pegfilgrastim has also successfully supported delivery of dose-dense chemotherapy, stem cell mobilization, and stem cell transplantation after high-dose chemotherapy in patients with non-myeloid or myeloid malignancies. By offering a convenient alternative to daily filgrastim, once-per-cycle administration of pegfilgrastim has the potential to simplify the management of chemotherapy-induced neutropenia, further improve patient health-related quality of life, and reduce total treatment costs in breast cancer and NHL, and possibly other cancer settings. Pegfilgrastim should, likewise, permit simplification of G-CSF-based stem cell mobilization and transplantation procedures.
聚乙二醇化重组人粒细胞集落刺激因子(Neulasta)是重组人粒细胞集落刺激因子(G-CSF)的长效剂型,通过将聚乙二醇(PEG)部分添加到重组人粒细胞集落刺激因子中制成。其在美国获批的适应症是降低接受骨髓抑制性化疗的非髓系恶性肿瘤患者发生发热性中性粒细胞减少所表现的感染发生率。在乳腺癌的中度骨髓抑制性化疗中,每化疗周期皮下注射一次聚乙二醇化重组人粒细胞集落刺激因子作为辅助治疗比安慰剂更有效;在乳腺癌的高强度骨髓抑制性化疗中,其效果不低于每日注射重组人粒细胞集落刺激因子;在淋巴瘤(主要是非霍奇金淋巴瘤[NHL])和急性髓系白血病的化疗中,其效果与每日注射重组人粒细胞集落刺激因子相同。聚乙二醇化重组人粒细胞集落刺激因子还成功支持了非髓系或髓系恶性肿瘤患者在剂量密集化疗、干细胞动员以及大剂量化疗后的干细胞移植。通过为每日注射重组人粒细胞集落刺激因子提供一种方便的替代方案,聚乙二醇化重组人粒细胞集落刺激因子每周期给药一次有可能简化化疗引起的中性粒细胞减少的管理,进一步改善患者与健康相关的生活质量,并降低乳腺癌和NHL以及可能其他癌症治疗环境中的总治疗成本。同样,聚乙二醇化重组人粒细胞集落刺激因子应该能够简化基于G-CSF的干细胞动员和移植程序。