Volovat Constantin, Gladkov Oleg A, Bondarenko Igor M, Barash Steve, Buchner Anton, Bias Peter, Adar Liat, Avisar Noa
Centrul de Oncologie Medicala, Iasi, Romania.
Chelyabinsk Regional Clinical Oncology Center, Chelyabinsk, Russia.
Clin Breast Cancer. 2014 Apr;14(2):101-8. doi: 10.1016/j.clbc.2013.10.001. Epub 2013 Oct 25.
Recombinant granulocyte colony-stimulating factors (G-CSFs) reduce the incidence and duration of chemotherapy-induced neutropenia and febrile neutropenia when given as adjunct therapy to patients receiving myelosuppressive chemotherapy. Balugrastim is a long-acting G-CSF composed of a genetic fusion between recombinant human serum albumin and G-CSF. We compared the efficacy and safety of balugrastim and pegfilgrastim, a long-acting pegylated recombinant G-CSF, in patients with breast cancer who were scheduled to receive chemotherapy.
In this double-blind randomized phase III trial, patients with ≥ 1.5 × 10(9) neutrophils/L were randomly assigned to subcutaneous injections of balugrastim 40 mg (n = 153) or pegfilgrastim 6 mg (n = 151). The primary efficacy end point was the duration of severe neutropenia (DSN) (days with an absolute neutrophil count [ANC] < 0.5 × 10(9) cells/L) during cycle 1. Efficacy analyses were performed in the per-protocol (PP) population. In a separate open-label single-arm study, newly recruited patients (n = 77) received balugrastim 40 mg and were included in the safety analysis.
The mean DSN in cycle 1 was 1.1 days in the balugrastim group and 1.0 days in the pegfilgrastim group (95% confidence interval [CI], -0.13-0.37). Two and 4 patients, respectively, had febrile neutropenia during cycle 1. Twenty percent of patients in the balugrastim group and 19% in the pegfilgrastim group had adverse events (AEs) considered to be related to study medication; 3.9% and 4.7% of patients, respectively, experienced serious AEs.
This study demonstrates the comparable safety and efficacy profile of balugrastim and pegfilgrastim and the noninferiority of balugrastim for reduction in DSN. There were no unexpected safety events.
重组粒细胞集落刺激因子（G-CSFs）作为接受骨髓抑制性化疗患者的辅助治疗药物时，可降低化疗引起的中性粒细胞减少症和发热性中性粒细胞减少症的发生率及持续时间。巴卢司亭是一种长效G-CSF，由重组人血清白蛋白和G-CSF基因融合而成。我们比较了巴卢司亭和培非司亭（一种长效聚乙二醇化重组G-CSF）在计划接受化疗的乳腺癌患者中的疗效和安全性。
在这项双盲随机III期试验中，中性粒细胞计数≥1.5×10⁹/L的患者被随机分配皮下注射40mg巴卢司亭（n = 153）或6mg培非司亭（n = 151）。主要疗效终点是第1周期严重中性粒细胞减少症（DSN）的持续时间（绝对中性粒细胞计数[ANC]<0.5×10⁹个细胞/L的天数）。在符合方案（PP）人群中进行疗效分析。在一项单独的开放标签单臂研究中，新招募的患者（n = 77）接受40mg巴卢司亭，并纳入安全性分析。
巴卢司亭组第1周期的平均DSN为1.1天，培非司亭组为1.0天（95%置信区间[CI]，-0.13 - 0.37）。第1周期分别有2例和4例患者发生发热性中性粒细胞减少症。巴卢司亭组20%的患者和培非司亭组19%的患者发生被认为与研究药物相关的不良事件（AE）；分别有3.9%和4.7%的患者发生严重AE。
本研究证明了巴卢司亭和培非司亭具有相当的安全性和疗效，且巴卢司亭在降低DSN方面不劣于培非司亭。未发生意外的安全事件。
