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.
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。