Budziszewska Bożena Katarzyna, Salomon-Perzyński Aleksander, Pruszczyk Katarzyna, Barankiewicz Joanna, Pluta Agnieszka, Helbig Grzegorz, Janowska Anna, Kuydowicz Marta, Bołkun Łukasz, Piszcz Jarosław, Patkowska Elżbieta, Wątek Marzena, Małecki Piotr, Kościołek-Zgódka Sylwia, Cichocka Edyta, Charliński Grzegorz, Irga-Staniukiewicz Anna, Zaucha Jan Maciej, Piekarska Agnieszka, Gromek Tomasz, Hus Marek, Wójcik Karol, Raźny Małgorzata, Sędzimirska Mariola, Puła Bartosz, Giebel Sebastian, Grosicki Sebastian, Wierzbowska Agnieszka, Lech-Marańda Ewa
Department of Hematology, Institute of Hematology and Transfusion Medicine, 02-776 Warsaw, Poland.
Centre of Postgraduate Medical Education, 01-813 Warsaw, Poland.
Cancers (Basel). 2021 Aug 20;13(16):4189. doi: 10.3390/cancers13164189.
Acute myeloid leukemia (AML) in older unfit patients is a therapeutic challenge for clinical hematologists. We evaluated the efficacy and safety of a novel low-intensity regimen consisting of low-dose cytarabine and cladribine (LD-AC+cladribine) in first-line treatment of elderly (≥60 years) AML patients not eligible for intensive chemotherapy (IC) who had either the Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2 or the hematopoietic cell transplantation comorbidity index (HCT-CI) score ≥3. The induction phase included two cycles of LD-AC+cladribine. Patients who achieved at least partial remission (PR) received maintenance treatment with LD-AC alone. Overall, 117 patients with a median age of 70 years were enrolled. Adverse cytogenetics, ECOG PS ≥2 and HCT-CI score ≥3 was observed in 43.5%, 60%, and 58% of patients, respectively. The response rate (≥PR) was 54% (complete remission [CR], 32%; CR with incomplete hematologic recovery [CRi], 5%). A median overall survival (OS) was 21 and 8.8 months in CR/CRi and PR group, respectively. Advanced age (≥75 years) and adverse cytogenetics had a negative impact on OS. The 56-day mortality rate was 20.5%. In conclusion, LD-AC+cladribine is a beneficial therapeutic option with a predictable safety profile in elderly AML patients not eligible for IC.
老年体弱患者的急性髓系白血病（AML）对临床血液科医生来说是一项治疗挑战。我们评估了一种由小剂量阿糖胞苷和克拉屈滨组成的新型低强度方案（LD-AC+克拉屈滨）在一线治疗老年（≥60岁）不适合接受强化化疗（IC）的AML患者中的疗效和安全性，这些患者的东部肿瘤协作组体能状态（ECOG PS）≥2或造血细胞移植合并症指数（HCT-CI）评分≥3。诱导期包括两个周期的LD-AC+克拉屈滨。达到至少部分缓解（PR）的患者接受单独使用LD-AC的维持治疗。总体而言，纳入了117例中位年龄为70岁的患者。分别有43.5%、60%和58%的患者存在不良细胞遗传学、ECOG PS≥2和HCT-CI评分≥3。缓解率（≥PR）为54%（完全缓解[CR]，32%；伴有血液学不完全恢复的CR[CRi]，5%）。CR/CRi组和PR组的中位总生存期（OS）分别为21个月和8.8个月。高龄（≥75岁）和不良细胞遗传学对OS有负面影响。56天死亡率为20.5%。总之，LD-AC+克拉屈滨对于不适合接受IC的老年AML患者是一种有益的治疗选择，其安全性可预测。
