Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer
Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer
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DOI：
10.1093/annonc/mdf130
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发表时间：
2002-06-01
影响因子：
50.5
通讯作者：
Liang, BC
中科院分区：
文献类型：
--
作者：
Holmes, FA;Jones, SE;Liang, BC
背景：中性粒细胞减少症在接受骨髓毒性化疗的患者中很常见。聚乙二醇非格司亭，一种持续时间非格司亭，是一种用于预防性中性粒细胞支持的每周期一次的疗法。 患者和方法：每 21 天接受四个周期的多柔比星/多西他赛化疗的女性，化疗后 24 小时接受聚乙二醇非格司亭或非格司亭，每个化疗周期单次皮下注射（聚乙二醇非格司亭 30、60 或 100 微克/公斤）或每天皮下注射注射（非格司亭 5 杯/公斤/天）。对安全性、有效性和药代动力学进行了分析。 结果：接受聚乙二醇非格司亭治疗的患者中，第 1 周期中 4 级中性粒细胞减少症的发生率分别为 95%、90% 和 74%。接受非格司亭治疗的患者分别为 30、60 和 100 微克/公斤，76%。第 1 周期中 4 级中性粒细胞减少症的平均持续时间，聚乙二醇非格司亭剂量为 2.7、2 和 1.3 天，非格司亭剂量为 1.6 天。聚乙二醇非格司亭的药代动力学是非线性的，并且依赖于剂量和中性粒细胞计数。培非格司亭血清浓度一直持续到中性粒细胞最低点出现，然后随着中性粒细胞开始恢复而迅速下降，这与中性粒细胞介导的自我调节清除机制一致。聚乙二醇非格司亭和非格司亭的安全性相似。结论：单次皮下注射聚乙二醇非格司亭 100 微克/公斤提供中性粒细胞支持，其安全性与多个化疗周期中每天皮下注射非格司亭相当。
Background: Neutropenia is common in patients receiving myelotoxic chemotherapy. Pegfilgrastim, a sustained-duration filgrastim is a once-per-cycle therapy for prophylactic neutrophil support.Patients and methods: Women, treated with four cycles of doxorubicin/docetaxel chemotherapy every 21 days, received pegfilgrastim or filgrastim 24 h after chemotherapy as a single subcutaneous injection per chemotherapy cycle (pegfilgrastim 30, 60 or 100 mug/kg) or daily subcutaneous injections (filgrastim 5 mug/kg/day). Safety, efficacy and pharmacokinetics were analyzed.Results: The incidence of grade 4 neutropenia in cycle 1 was 95, 90 and 74%, in patients who received pegfilgrastim. 30, 60 and 100 mug/kg, respectively, and 76% in patients who received filgrastim. Mean duration of grade 4 neutropenia in cycle 1 was 2.7, 2 and 1.3 days for doses of pegfilgrastim, and 1.6 days for filgrastim. The pharmacokinetics of pegfilgrastim were non-linear and dependent on both dose and neutrophil count. Pegfilgrastim serum concentration was sustained until the neutrophil nadir occurred then declined rapidly as neutrophils started to recover, consistent with a self-regulating neutrophil-mediated clearance mechanism. The safety profiles of pegfilgrastim and filgrastim were similar.Conclusions: A single subcutaneous injection of pegfilgrastim 100 mug/kg provided neutrophil support and a safety profile comparable to daily subcutaneous injections of filgrastim during multiple chemotherapy cycles.