Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.
Division of Biostatistics, German Cancer Research Center, Heidelberg, Germany.
Blood Cancer J. 2017 May 26;7(5):e564. doi: 10.1038/bcj.2017.45.
The aim of this cohort study was to compare a condensed schedule of consolidation therapy with high-dose cytarabine on days 1, 2 and 3 (HDAC-123) with the HDAC schedule given on days 1, 3 and 5 (HDAC-135) as well as to evaluate the prophylactic use of pegfilgrastim after chemotherapy in younger patients with acute myeloid leukemia in first complete remission. One hundred and seventy-six patients were treated with HDAC-135 and 392 patients with HDAC-123 with prophylactic pegfilgrastim at days 10 and 8, respectively, in the AMLSG 07-04 and the German AML Intergroup protocol. Time from start to chemotherapy until hematologic recovery with white blood cells >1.0 G/l and neutrophils >0.5 G/l was in median 4 days shorter in patients receiving HDAC-123 compared with HDAC-135 (P<0.0001, each), and further reduced by 2 days (P<0.0001) by pegfilgrastim. Rates of infections were reduced by HDAC-123 (P<0.0001) and pegfilgrastim (P=0.002). Days in hospital and platelet transfusions were significantly reduced by HDAC-123 compared with HDAC-135. Survival was neither affected by HDAC-123 versus HDAC-135 nor by pegfilgrastim. In conclusion, consolidation therapy with HDAC-123 leads to faster hematologic recovery and less infections, platelet transfusions as well as days in hospital without affecting survival.
本队列研究旨在比较强化治疗的浓缩方案与高剂量阿糖胞苷（HDAC-123，第 1、2 和 3 天）和 HDAC-135（第 1、3 和 5 天），以及评估在首次完全缓解的年轻急性髓细胞白血病患者中化疗后预防性使用培非格司亭。176 例患者接受 HDAC-135 治疗，392 例患者接受 HDAC-123 治疗，分别在 AMLSG 07-04 和德国 AML 联合组方案中预防性使用培非格司亭第 10 天和第 8 天。与 HDAC-135 相比，接受 HDAC-123 治疗的患者从化疗开始到白细胞>1.0G/l 和中性粒细胞>0.5G/l 恢复的时间中位数缩短了 4 天（P<0.0001，均），培非格司亭进一步缩短了 2 天（P<0.0001）。HDAC-123 降低了感染率（P<0.0001），培非格司亭（P=0.002）。与 HDAC-135 相比，HDAC-123 降低了住院天数和血小板输注。与 HDAC-135 相比，HDAC-123 治疗并未影响生存。结论：HDAC-123 强化治疗可更快地恢复血液学，减少感染、血小板输注和住院天数，而不影响生存。
