埃非白美兰重组人粒细胞刺激因子在为接受骨髓毒性化疗的乳腺癌女性提供中性粒细胞支持方面不劣于培非格司亭：一项 2 期随机、多中心、开放性试验的结果。
Efbemalenograstim alfa not inferior to pegfilgrastim in providing neutrophil support in women with breast cancer undergoing myelotoxic chemotherapy: results of a phase 2 randomized, multicenter, open-label trial.
机构信息
UCLA School of Medicine, 100 UCLA Medical Plaza, Suite 550, Los Angeles, CA, 90095-6956, USA.
Dnepropetrovsk Medical Academy, Dnepropetrovsk, Ukraine.
出版信息
Support Care Cancer. 2024 Jan 9;32(2):91. doi: 10.1007/s00520-023-08260-x.
PURPOSE
Evaluate the safety and efficacy of efbemalenograstim alfa for neutrophil support in breast cancer patients undergoing myelosuppressive chemotherapy in a phase 2, dose-finding, open-label study (NCT01648322, ClinicalTrials.gov, 2012-07-19).
METHODS
232 patients received up to 4 cycles of chemotherapy, 141 patients with docetaxel + cyclophosphamide (TC) and 91 patients with docetaxel + doxorubicin + cyclophosphamide (TAC). Patients were randomized to efbemalenograstim alfa (80, 240, or 320 µg/kg [TC]; 240 or 320 µg/kg [TAC]) or pegfilgrastim (6 mg) on Day 2 of each cycle.
RESULTS
Efbemalenograstim alfa was non-inferior to pegfilgrastim in duration of moderate and severe neutropenia (absolute neutrophil count [ANC] < 1.0 × 10/L) in TAC Cycle 1 (mean [SD] of 2.1 [1.58] and 2.1 [1.46] days for 240 µg/kg and 320 µg/kg efbemalenograstim alfa, respectively, and 1.8 [1.28] days for pegfilgrastim), with a difference (95% CI) of 0.3 (-0.4, 1.1) days. ANC nadir occurred between Days 7-8 of TAC Cycle 1, with mean [SD] of 0.68 [1.064], 0.86 [1.407] and 0.78[1.283] × 10/L for 240 µg/kg, 320 µg/kg efbemalenograstim alfa and pegfilgrastim, respectively. Time to ANC recovery post nadir (defined as an ANC > 2.0 × 10/L after the expected ANC nadir) was 2.0-2.4 and 1.9 days for TAC patients treated with efbemalenograstim alfa and pegfilgrastim, respectively. No significant difference was found between any dose of efbemalenograstim alfa and pegfilgrastim in TAC Cycle 1 for incidence of moderate to severe neutropenia (76%-77% of patients) or incidence of severe neutropenia (ANC < 0.5 × 10/L; 63%-72%). Efbemalenograstim alfa exhibited similar safety profile to pegfilgrastim. Febrile neutropenia occurred in 4 (1.8%) patients, 2 patients each for 320 µg/kg efbemalenograstim alfa and pegfilgrastim, with no event considered related to study drug.
CONCLUSION
Efbemalenograstim alfa was comparable to pegfilgrastim in efficacy and safety.
GOV IDENTIFIER
NCT01648322.
目的
在一项 2 期、剂量发现、开放标签研究（NCT01648322，ClinicalTrials.gov，2012-07-19）中评估 efbemalenograstim alfa 在接受骨髓抑制化疗的乳腺癌患者中的中性粒细胞支持安全性和疗效。
方法
232 例患者接受了多达 4 个周期的化疗，141 例患者接受多西他赛+环磷酰胺（TC）治疗，91 例患者接受多西他赛+多柔比星+环磷酰胺（TAC）治疗。患者随机接受 efbemalenograstim alfa（80、240 或 320µg/kg[TC]；240 或 320µg/kg[TAC]）或培非格司亭（6mg），于每个周期的第 2 天给药。
结果
在 TAC 周期 1 中，efbemalenograstim alfa 在中重度中性粒细胞减少症（绝对中性粒细胞计数[ANC]＜1.0×10/L）的持续时间方面与培非格司亭无差异（240µg/kg 和 320µg/kg efbemalenograstim alfa 分别为 2.1[1.58]和 2.1[1.46]天，培非格司亭为 1.8[1.28]天），差异为 0.3（-0.4，1.1）天。TAC 周期 1 中 ANC 最低点发生在第 7-8 天，分别为 0.68[1.064]、0.86[1.407]和 0.78[1.283]×10/L，240µg/kg、320µg/kg efbemalenograstim alfa 和培非格司亭。ANC 最低点后恢复时间（定义为 ANC 预期最低点后＞2.0×10/L）为 TAC 患者接受 efbemalenograstim alfa 和培非格司亭治疗的 2.0-2.4 和 1.9 天。在 TAC 周期 1 中，任何剂量的 efbemalenograstim alfa 与培非格司亭相比，中重度中性粒细胞减少症（76%-77%的患者）或重度中性粒细胞减少症（ANC＜0.5×10/L；63%-72%）的发生率均无显著差异。efbemalenograstim alfa 表现出与培非格司亭相似的安全性特征。发热性中性粒细胞减少症发生在 4（1.8%）例患者中，2 例患者各接受 320µg/kg efbemalenograstim alfa 和培非格司亭治疗，无事件被认为与研究药物有关。
结论
efbemalenograstim alfa 在疗效和安全性方面与培非格司亭相当。
政府标识符
NCT01648322。
Zotero 插件