Harousseau J L, Witz B, Lioure B, Hunault-Berger M, Desablens B, Delain M, Guilhot F, Le Prise P Y, Abgrall J F, Deconinck E, Guyotat D, Vilque J P, Casassus P, Tournilhac O, Audhuy B, Solary E
Departments of Hematology of University Hospital, Nantes, France.
J Clin Oncol. 2000 Feb;18(4):780-7. doi: 10.1200/JCO.2000.18.4.780.
Ten years after the first clinical studies, the clinical impact of myeloid growth factors in acute myeloid leukemia is still unclear. One of the objectives of the Groupe Ouest-Est Leucémies Aigues Myeloblastiques (GOELAM) 2 trial was to evaluate the benefit of granulocyte colony-stimulating factor (GCSF) given only after the two courses of intensive consolidation chemotherapy (ICC) used to maintain complete remission (CR).
One hundred ninety-four patients who were in CR after induction treatment were randomly assigned to receive G-CSF (100 patients) or no G-CSF (94 patients) after two courses of ICC (ICC 1, high-dose cytarabine plus mitoxantrone; ICC 2, amsacrine plus etoposide). G-CSF (filgrastim) was administered from the day after chemotherapy until granulocyte recovery at a daily dose of 5 microg/kg.
In the G-CSF group, the median duration of neutropenia (< 0.5 x 10(9)/L) was dramatically reduced, both after ICC 1 (12 v 19 days, P <.001) and after ICC 2 (20 v 28 days, P <.001). The median duration of hospitalization was also significantly shorter in the G-CSF group (24 v 27 days after ICC 1, P <.001; 29 v 34 days after ICC 2, P <. 001). The median duration of intravenous antibiotics was significantly reduced after ICC 1 and ICC 2, and the median duration of antifungal therapy was significantly reduced after ICC 1. However, the incidence of microbiologically documented infections, the toxic death rate, the 2-year disease-free survival, and the 2-year overall survival were not affected by G-CSF administration. Moreover, the median interval between ICC1 and ICC2 was reduced by only 2 days, and the number of patients undergoing ICC2 was not increased in the G-CSF arm.
G-CSF should be administered routinely after ICC to reduce the duration of neutropenia and hospitalization. However, G-CSF did not seem to significantly increase the feasibility of this two-course program or modify overall outcome.
在首次临床研究开展十年后，髓系生长因子在急性髓系白血病中的临床影响仍不明确。东西方急性髓系白血病协作组（GOELAM）2试验的目标之一是评估仅在用于维持完全缓解（CR）的两个疗程强化巩固化疗（ICC）后给予粒细胞集落刺激因子（GCSF）的益处。
194例诱导治疗后处于CR的患者在两个疗程的ICC（ICC 1，大剂量阿糖胞苷加米托蒽醌；ICC 2，安吖啶加依托泊苷）后被随机分配接受G-CSF（100例患者）或不接受G-CSF（94例患者）。G-CSF（非格司亭）从化疗后次日开始给药，直至粒细胞恢复，每日剂量为5μg/kg。
在G-CSF组，中性粒细胞减少（<0.5×10⁹/L）的中位持续时间在ICC 1后（12天对19天，P<0.001）和ICC 2后（20天对28天，P<0.001）均显著缩短。G-CSF组的中位住院时间也显著缩短（ICC 1后24天对27天，P<0.001；ICC 2后29天对34天，P<0.001）。ICC 1和ICC 2后静脉使用抗生素的中位持续时间显著缩短，ICC 1后抗真菌治疗的中位持续时间显著缩短。然而，微生物学证实的感染发生率、毒性死亡率、2年无病生存率和2年总生存率不受G-CSF给药的影响。此外，ICC1和ICC2之间的中位间隔仅缩短了2天，G-CSF组接受ICC2的患者数量未增加。
ICC后应常规给予G-CSF以缩短中性粒细胞减少和住院的持续时间。然而，G-CSF似乎并未显著提高这个两疗程方案的可行性或改变总体结局。
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