Muluneh Benyam, Buhlinger Kaitlyn, Deal Allison M, Zeidner Joshua F, Foster Matthew C, Jamieson Katarzyna Joanna, Bates Jill, Van Deventer Hendrik W
Department of Pharmacy, University of North Carolina Medical Center, Chapel Hill, NC; University of North Carolina Eshelman School of Pharmacy, Chapel Hill, NC.
Department of Pharmacy, University of North Carolina Medical Center, Chapel Hill, NC.
Clin Lymphoma Myeloma Leuk. 2018 Jan;18(1):e13-e18. doi: 10.1016/j.clml.2017.09.016. Epub 2017 Sep 22.
Salvage regimens for patients with relapsed/refractory acute myeloid leukemia (rrAML) lack comparative data for superiority. Thus, we conducted a retrospective analysis of clofarabine-based (GCLAC; granulocyte colony-stimulating factor [filgrastim], clofarabine, high-dose cytarabine) versus cladribine-based (CLAG; cladribine, cytarabine, granulocyte colony-stimulating factor [filgrastim]) regimens in rrAML.
We identified 41 consecutive patients with rrAML who had received either GCLAC or CLAG from 2011 to 2014. The primary outcome measure was the complete remission (CR) rate defined according to the International Working Group criteria. The secondary outcomes included the proportion of patients who underwent allogenic stem cell transplantation and the rate of relapse-free survival and overall survival.
We found no significant differences in the baseline characteristics of the patients treated with GCLAC (n = 22) or CLAG (n = 19). The outcomes with these 2 regimens were not significantly different. Patients treated with GCLAC had a CR/CR with incomplete blood count recovery rate of 64% compared with 47% for the patients treated with CLAG (P = .36). Of the GCLAC patients, 45% underwent allogeneic stem cell transplantation compared with 26% of the CLAG patients (P = .32). The median relapse-free survival after GCLAC and CLAG was 1.59 years and 1.03 years, respectively (P = .75). The median overall survival after GCLAG and CLAG was 1.03 years and 0.70 years, respectively (P = .08). The drug costs were significantly different for GCLAC versus CLAG. Using an average wholesale price, the cost per patient per cycle was $60,821.60 for GCLAC and $4910.60 for CLAG.
A single-institutional retrospective analysis found no significant differences in the outcomes between GCLAC and CLAG for rrAML patients, although formal comparisons should be performed in a randomized clinical trial. The cost of GCLAC was greater than that of CLAG, which should be considered when evaluating the choice for the salvage chemotherapy options.
复发/难治性急性髓系白血病（rrAML）患者的挽救治疗方案缺乏优越性的对比数据。因此，我们对rrAML患者中基于氯法拉滨的方案（GCLAC；粒细胞集落刺激因子[非格司亭]、氯法拉滨、大剂量阿糖胞苷）与基于克拉屈滨的方案（CLAG；克拉屈滨、阿糖胞苷、粒细胞集落刺激因子[非格司亭]）进行了回顾性分析。
我们确定了2011年至2014年期间连续接受GCLAC或CLAG治疗的41例rrAML患者。主要结局指标是根据国际工作组标准定义的完全缓解（CR）率。次要结局包括接受异基因干细胞移植的患者比例、无复发生存率和总生存率。
我们发现接受GCLAC治疗的患者（n = 22）和接受CLAG治疗的患者（n = 19）的基线特征无显著差异。这两种方案的结局无显著差异。接受GCLAC治疗的患者CR/血细胞计数未完全恢复的CR率为64%，而接受CLAG治疗的患者为47%（P = 0.36）。在接受GCLAC治疗的患者中，45%接受了异基因干细胞移植，而接受CLAG治疗的患者为26%（P = 0.32）。GCLAC和CLAG治疗后的无复发生存期中位数分别为1.59年和1.03年（P = 0.75）。GCLAG和CLAG治疗后的总生存期中位数分别为1.03年和0.70年（P = 0.08）。GCLAC与CLAG的药物成本存在显著差异。按照平均批发价格，GCLAC方案每位患者每周期的成本为60821.60美元，CLAG方案为4910.60美元。
一项单机构回顾性分析发现，对于rrAML患者，GCLAC和CLAG方案的结局无显著差异，尽管应在随机临床试验中进行正式比较。GCLAC的成本高于CLAG，在评估挽救化疗方案的选择时应予以考虑。
