Aarts Maureen J, Vriens Birgit E, de Boer Maaike, Peters Frank P, Mandigers Caroline M, Dercksen M Wouter, Stouthard Jacqueline M, Tol Jolien, van Warmerdam Laurence J, van de Wouw Agnes J, Jacobs Esther M, van der Rijt Carin C D, Smilde Tineke J, van der Velden Annette W, Peer Nelly, Tjan-Heijnen Vivianne C G
Department of Medical Oncology, Maastricht University Medical Centre, GROW School for Oncology and Developmental Biology, Maastricht, The Netherlands.
Oncology. 2017;93(5):323-328. doi: 10.1159/000479067. Epub 2017 Aug 22.
The primary outcome of the current study is, whether there is a protective effect of prior chemotherapy or of prior granulocyte colony-stimulating factor (G-CSF) on the next cycle blood cell counts.
Hematologic toxicity was evaluated, based on a randomized phase III study in breast cancer patients (n = 167) with >20% risk of febrile neutropenia. The primary endpoint was the nadir blood cell counts for patients treated with G-CSF given during all 6 chemotherapy cycles or limited to the first 2 chemotherapy cycles only.
For the present analyses, 47 patients were eligible. In the G-CSF 1-6 arm, the median white blood cell count (WBC) and absolute neutrophil count (ANC) nadir slowly decreased from 10.8 × 109/L in cycle 1 to 7.5 × 109/L in cycle 6 and from 7.1 × 109/L to 5.5 × 109/L, respectively. The median WBC nadir in the G-CSF 1-2 arm decreased from 1.2 × 109/L in cycle 3 to 0.9 × 109/L in cycle 6 and the ANC nadir showed a grade 4 neutropenia of 0.1 × 109/L in cycles 3-6. All patients had ANC recovery to normal levels (≥1.5 × 109/L) without delay on day 1 of the next cycle.
We conclude that there is no protective effect of prior G-CSF or prior chemotherapy use on nadir blood cell counts in subsequent cycles.
本研究的主要结果是,既往化疗或既往使用粒细胞集落刺激因子(G-CSF)对下一周期血细胞计数是否具有保护作用。
基于一项针对发热性中性粒细胞减少风险>20%的乳腺癌患者(n = 167)的随机III期研究,评估血液学毒性。主要终点是在所有6个化疗周期或仅在前2个化疗周期给予G-CSF治疗的患者的最低点血细胞计数。
对于本次分析,47例患者符合条件。在G-CSF 1-6组中,白细胞计数(WBC)和绝对中性粒细胞计数(ANC)最低点中位数从第1周期的10.8×10⁹/L缓慢降至第6周期的7.5×10⁹/L,以及分别从7.1×10⁹/L降至5.5×10⁹/L。G-CSF 1-2组中WBC最低点中位数从第3周期的1.2×10⁹/L降至第6周期的0.9×10⁹/L,且ANC最低点在第3-6周期显示为4级中性粒细胞减少,为0.1×10⁹/L。所有患者在下一周期第1天ANC均无延迟地恢复至正常水平(≥1.5×10⁹/L)。
我们得出结论,既往使用G-CSF或既往化疗对后续周期的最低点血细胞计数没有保护作用。