Sperr Wolfgang R, Herndlhofer Susanne, Gleixner Karoline, Girschikofsky Michael, Weltermann Ansgar, Machherndl-Spandl Sigrid, Sliwa Thamer, Poehnl Rainer, Buxhofer-Ausch Veronika, Strecker Karin, Hoermann Gregor, Knoebl Paul, Jaeger Ulrich, Geissler Klaus, Kundi Michael, Valent Peter
Department of Internal Medicine I, Division of Hematology and Hemostaseology, Medical University of Vienna, Wien, Austria.
Ludwig Boltzmann Cluster Oncology, Medical University of Vienna, Wien, Austria.
Am J Hematol. 2017 Oct;92(10):E567-E574. doi: 10.1002/ajh.24847. Epub 2017 Aug 17.
The aim of this study was to evaluate the efficacy and feasibility of intensified consolidation therapy employing fludarabine and ARA-C in cycle 1 and intermediate-dose ARA-C (IDAC) in cycles 2 through 4, in elderly acute myeloid leukemia (AML) patients and to analyze the effects of pegfilgrastim on the duration of neutropenia, overall toxicity, and hospitalization-time during consolidation in these patients. Thirty nine elderly patients with de novo AML (median age 69.9 years) who achieved complete remission (CR) after induction-chemotherapy were analyzed. To examine the effect of pegfilgrastim on neutropenia and hospitalization, we compared cycles 2 and 4 where pegfilgrastim was given routinely from day 6 (IDAC-P) with cycle 3 where pegfilgrastim was only administered in case of severe infections and/or prolonged neutropenia. All four planned cycles were administered in 23/39 patients (59.0%); 5/39 patients (12.8%) received 3 cycles, 3/39 (7.7%) 2 cycles, and 8/39 (20.5%) one consolidation-cycle. The median duration of severe neutropenia was 7 days in cycle 2 (IDAC-P), 11.5 days in cycle 3 (IDAC), and 7.5 days in cycle 4 (IDAC-P) (P < .05). Median overall survival was 1.1 years and differed significantly between patients aged <75 and ≥75 years (P < .05). The probability to be alive after 5 years was 32%. Together, intensified consolidation can be administered in AML patients ≥60, and those who are <75 may benefit from this therapy. Routine administration of pegfilgrastim during consolidation shortens the time of neutropenia and hospitalization in these patients.
本研究旨在评估在老年急性髓系白血病（AML）患者中，第1周期采用氟达拉滨和阿糖胞苷（ARA-C）以及第2至4周期采用中剂量阿糖胞苷（IDAC）进行强化巩固治疗的疗效和可行性，并分析培非格司亭对这些患者巩固治疗期间中性粒细胞减少持续时间、总体毒性和住院时间的影响。分析了39例初治AML老年患者（中位年龄69.9岁），这些患者在诱导化疗后达到完全缓解（CR）。为了研究培非格司亭对中性粒细胞减少和住院情况的影响，我们比较了第2周期和第4周期（从第6天起常规给予培非格司亭，即IDAC-P）与第3周期（仅在发生严重感染和/或长期中性粒细胞减少时给予培非格司亭）。39例患者中有23例（59.0%）接受了全部4个计划周期的治疗；5例（12.8%）接受了3个周期，3例（7.7%）接受了2个周期，8例（20.5%）接受了1个巩固周期。第2周期（IDAC-P）严重中性粒细胞减少的中位持续时间为7天，第3周期（IDAC）为11.5天，第4周期（IDAC-P）为7.5天（P＜0.05）。中位总生存期为1.1年，年龄＜75岁和≥75岁的患者之间存在显著差异（P＜0.05）。5年后的生存概率为32%。总之，强化巩固治疗可应用于≥60岁的AML患者，年龄＜75岁的患者可能从该治疗中获益。在巩固治疗期间常规给予培非格司亭可缩短这些患者的中性粒细胞减少时间和住院时间。
