Private Practice Hematology Medical Oncology, Finkenhain 8, 67661, Kaiserslautern, Germany.
Hematology, Oncology and Palliative Medicine Clinic, Klinikum Stuttgart, Stuttgart, Germany.
Support Care Cancer. 2021 May;29(5):2519-2527. doi: 10.1007/s00520-020-05711-7. Epub 2020 Sep 17.
Lipegfilgrastim has been shown to be non-inferior to pegfilgrastim for reduction of the duration of severe neutropenia (DSN) in breast cancer patients. This open-label, non-inferiority study assessed the efficacy and safety of lipegfilgrastim versus pegfilgrastim in elderly patients with aggressive B cell non-Hodgkin lymphoma (NHL) at high risk for chemotherapy-induced neutropenia.
One hundred and one patients (median age, 75 years) were randomized to lipegfilgrastim or pegfilgrastim (6 mg/cycle) during six cycles of R-CHOP21.
Lipegfilgrastim was non-inferior to pegfilgrastim for the primary efficacy endpoint, reduction of DSN in cycle 1. In the per-protocol population, mean (standard deviation) DSN was 0.8 (0.92) and 0.9 (1.11) days in the two groups, respectively; the adjusted mean difference between groups was - 0.3 days (95% confidence interval, - 0.70 to 0.19). Non-inferiority was also demonstrated in the intent-to-treat population. The incidence of severe neutropenia in cycle 1 was 51% (21/41) in the lipegfilgrastim group and 52% (23/44) in the pegfilgrastim group. Very severe neutropenia (ANC < 0.1 × 10/L) in cycle 1 was reported by 5 (12%) patients in the lipegfilgrastim group and 8 (18%) patients in the pegfilgrastim group. However, over all cycles, febrile neutropenia (strict definition) was reported by only 1 (2%) patient in each treatment group (during cycle 1 in the lipegfilgrastim group and cycle 6 in the pegfilgrastim group). The mean time to absolute neutrophil count recovery (defined as ≥ 2.0 × 10/L) was 8.3 and 9.4 days in the two groups, respectively. Serious adverse events occurred in 46% of patients in each group; none were considered treatment-related. Eight patients died during the study (2 in the lipegfilgrastim group, 5 in the pegfilgrastim group, and 1 who died before starting study treatment). No deaths occurred during the treatment period, and all were considered to be related to the underlying disease.
This study shows lipegfilgrastim to be non-inferior to pegfilgrastim for the reduction of DSN in elderly patients with aggressive B cell NHL receiving myelosuppressive chemotherapy, with a comparable safety profile.
ClinicalTrials.gov identifier NCT02044276; EudraCT number 2013-001284-23.
利培格司组在降低乳腺癌患者严重中性粒细胞减少症（DSN）持续时间方面已被证明不劣于培格司组。这项开放标签、非劣效性研究评估了利培格司组与培格司组在高危化疗诱导中性粒细胞减少的侵袭性 B 细胞非霍奇金淋巴瘤（NHL）老年患者中的疗效和安全性。
101 例患者（中位年龄，75 岁）在 6 个周期的 R-CHOP21 期间被随机分配至利培格司组或培格司组（6mg/周期）。
利培格司在主要疗效终点、第 1 周期 DSN 减少方面不劣于培格司。在方案人群中，两组的平均（标准差）DSN 分别为 0.8（0.92）和 0.9（1.11）天；组间调整平均差异为 -0.3 天（95%置信区间，-0.70 至 0.19）。意向治疗人群也显示了非劣效性。第 1 周期严重中性粒细胞减少症的发生率在利培格司组为 51%（21/41），在培格司组为 52%（23/44）。第 1 周期非常严重中性粒细胞减少症（ANC<0.1×10/L）在利培格司组报告了 5 例（12%），在培格司组报告了 8 例（18%）。然而，在所有周期中，发热性中性粒细胞减少症（严格定义）仅在每个治疗组的 1 例（利培格司组第 1 周期和培格司组第 6 周期）中报告。两组中性粒细胞绝对计数恢复（定义为≥2.0×10/L）的平均时间分别为 8.3 和 9.4 天。两组各有 46%的患者发生严重不良事件；均与治疗无关。8 例患者在研究期间死亡（利培格司组 2 例，培格司组 5 例，1 例在开始研究治疗前死亡）。在治疗期间无死亡发生，均被认为与基础疾病有关。
这项研究表明，在接受骨髓抑制化疗的侵袭性 B 细胞 NHL 老年患者中，利培格司在降低 DSN 方面不劣于培格司，且安全性相当。
ClinicalTrials.gov 标识符 NCT02044276；EudraCT 编号 2013-001284-23。
