Abstract：
OBJECTIVE: The recommended dosage of pegylated recombinant human granulocyte-colony stimulating factor (PEG-rhG-CSF) for Western chemotherapy patients is 6 mg per cycle. However, for Eastern Asians, the optimal dose remains unknown.
METHODS: This open-label, randomized, non-inferiority trial (NCT05283616) enrolled Chinese female breast cancer patients receiving adjuvant chemotherapy. Participants were randomized to receive either 3 or 6 mg of PEG-rhG-CSF per cycle, stratified by body weight (BW; ≤60 kg vs. >60 kg). The primary endpoint was timely absolute neutrophil count (ANC) recovery before the second cycle of chemotherapy.
RESULTS: A total of 122 patients were randomized and 116 were included for efficacy analyses. The timely ANC recovery rate in the 3 mg arm was 89.8%, compared to 93.0% in the 6 mg arm (one-sided 95% confidence interval [CI] lower limit for difference: -11.7%), meeting the prespecified non-inferiority margin of 15%. The rate was 93.3% with PEG-rhG-CSF 3 mg and 96.6% with 6 mg in patients with BW ≤ 60 kg, and 86.2% and 89.3%, respectively, in those with BW > 60 kg. Although the incidence of severe neutropenia was similar across arms, the occurrence of excessively high ANC and white blood cell counts was higher in the 6 mg arm. No grade ≥3 adverse events related to PEG-rhG-CSF occurred.
CONCLUSIONS: Three milligrams of PEG-rhG-CSF per cycle provided non-inferior neutrophil protection and attenuated neutrophil overshoot compared to 6 mg doses. This low-dose regimen could be a new supportive care option for Chinese breast cancer patients receiving anthracycline-based adjuvant chemotherapy.
METHODS: This open-label, randomized, non-inferiority trial (NCT05283616) enrolled Chinese female breast cancer patients receiving adjuvant chemotherapy. Participants were randomized to receive either 3 or 6 mg of PEG-rhG-CSF per cycle, stratified by body weight (BW; ≤60 kg vs. >60 kg). The primary endpoint was timely absolute neutrophil count (ANC) recovery before the second cycle of chemotherapy.
RESULTS: A total of 122 patients were randomized and 116 were included for efficacy analyses. The timely ANC recovery rate in the 3 mg arm was 89.8%, compared to 93.0% in the 6 mg arm (one-sided 95% confidence interval [CI] lower limit for difference: -11.7%), meeting the prespecified non-inferiority margin of 15%. The rate was 93.3% with PEG-rhG-CSF 3 mg and 96.6% with 6 mg in patients with BW ≤ 60 kg, and 86.2% and 89.3%, respectively, in those with BW > 60 kg. Although the incidence of severe neutropenia was similar across arms, the occurrence of excessively high ANC and white blood cell counts was higher in the 6 mg arm. No grade ≥3 adverse events related to PEG-rhG-CSF occurred.
CONCLUSIONS: Three milligrams of PEG-rhG-CSF per cycle provided non-inferior neutrophil protection and attenuated neutrophil overshoot compared to 6 mg doses. This low-dose regimen could be a new supportive care option for Chinese breast cancer patients receiving anthracycline-based adjuvant chemotherapy.
摘要：
目的：西医化疗患者聚乙二醇化重组人粒细胞集落刺激因子(PEG-rhG-CSF)的推荐剂量为6mg/周期。然而,对于东亚人来说，最佳剂量仍然未知。
方法：这个开放标签，随机化，非劣效性试验（NCT05283616）纳入了接受辅助化疗的中国女性乳腺癌患者。参与者随机接受3或6毫克的PEG-rhG-CSF每周期，按体重分层(体重；≤60公斤与>60公斤)。主要终点是第二周期化疗前及时的中性粒细胞绝对计数（ANC）恢复。
结果：共有122例患者被随机分组，116例纳入疗效分析。3mg臂的及时ANC恢复率为89.8％，与6mg组的93.0%相比（单侧95%置信区间[CI]差异下限：-11.7%），满足15%的预设非劣效性。BW≤60kg的患者中，PEG-rhG-CSF3mg的发生率为93.3％，6mg的发生率为96.6％。86.2%和89.3%，分别,在那些与BW>60公斤。尽管严重中性粒细胞减少症的发病率在不同的手臂是相似的，在6mg组患者中，过高的ANC和白细胞计数的发生率更高。未发生与PEG-rhG-CSF相关的≥3级不良事件。
结论：与6mg剂量相比，每个周期3毫克的PEG-rhG-CSF提供了非下中性粒细胞保护和减少的中性粒细胞超调。对于接受蒽环类药物辅助化疗的中国乳腺癌患者，这种低剂量方案可能是一种新的支持性治疗选择。
方法：这个开放标签，随机化，非劣效性试验（NCT05283616）纳入了接受辅助化疗的中国女性乳腺癌患者。参与者随机接受3或6毫克的PEG-rhG-CSF每周期，按体重分层(体重；≤60公斤与>60公斤)。主要终点是第二周期化疗前及时的中性粒细胞绝对计数（ANC）恢复。
结果：共有122例患者被随机分组，116例纳入疗效分析。3mg臂的及时ANC恢复率为89.8％，与6mg组的93.0%相比（单侧95%置信区间[CI]差异下限：-11.7%），满足15%的预设非劣效性。BW≤60kg的患者中，PEG-rhG-CSF3mg的发生率为93.3％，6mg的发生率为96.6％。86.2%和89.3%，分别,在那些与BW>60公斤。尽管严重中性粒细胞减少症的发病率在不同的手臂是相似的，在6mg组患者中，过高的ANC和白细胞计数的发生率更高。未发生与PEG-rhG-CSF相关的≥3级不良事件。
结论：与6mg剂量相比，每个周期3毫克的PEG-rhG-CSF提供了非下中性粒细胞保护和减少的中性粒细胞超调。对于接受蒽环类药物辅助化疗的中国乳腺癌患者，这种低剂量方案可能是一种新的支持性治疗选择。
