Cladribine Combined with Low-Dose Cytarabine as Frontline Treatment for Unfit Elderly Acute Myeloid Leukemia Patients: Results from a Prospective Multicenter Study of Polish Adult Leukemia Group (PALG)

Author:

Budziszewska Bożena KatarzynaORCID,Salomon-Perzyński AleksanderORCID,Pruszczyk Katarzyna,Barankiewicz JoannaORCID,Pluta Agnieszka,Helbig Grzegorz,Janowska Anna,Kuydowicz Marta,Bołkun ŁukaszORCID,Piszcz Jarosław,Patkowska ElżbietaORCID,Wątek Marzena,Małecki Piotr,Kościołek-Zgódka Sylwia,Cichocka Edyta,Charliński GrzegorzORCID,Irga-Staniukiewicz Anna,Zaucha Jan Maciej,Piekarska Agnieszka,Gromek Tomasz,Hus Marek,Wójcik Karol,Raźny Małgorzata,Sędzimirska Mariola,Puła Bartosz,Giebel Sebastian,Grosicki SebastianORCID,Wierzbowska Agnieszka,Lech-Marańda Ewa

Abstract

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.

Funder

Institute of Hematology and Transfusion Medicine in Warsaw

Publisher

MDPI AG

Subject

Cancer Research,Oncology

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