In a nutshell
This study aimed to investigate the effectiveness and safety of clofarabine, cytarabine, and mitoxantrone (CLAM) in relapsed or refractory (unresponsive) acute myeloid leukemia.
This study concluded that this combination was safe and effective in these patients.
3+7 treatment is a standard treatment for AML and consists of an anthracycline (daunorubicin) and cytarabine. However, not all patients respond to this treatment.
Clofarabine (Clolar) is a treatment mainly used for acute lymphocytic leukemia in children. However, it is active in relapsed/refractory (r/r) acute myeloid leukemia (AML). Cytarabine (ara-C) and mitoxantrone (Novantrone) are chemotherapy drugs used in AML. CLAM treatment consists of clofarabine, cytarabine, and mitoxantrone. It was not known if CLAM was safe and effective in patients with AML who did not respond to 3+7 standard treatment.
Methods & findings
This study involved 52 patients with AML who were refractory to first-line 3 + 7 induction or relapsing after 3 + 7 induction and CLAM. All patients were treated with CLAM. Patients who achieved remission had received up to two cycles of CLAM.
The overall response rate (ORR) after the first cycle of CLAM was 90.4%. The rate of complete remission (CR) after the first cycle of CLAM was 69.2%. The rate of CR with incomplete hematologic recovery (CRi; complete disappearance of cancer but with still abnormal blood cell counts) was 21.2%.
22 patients with CR/CRi underwent allogeneic hemopoietic stem cell transplant (allo-HSCT). Allo-HSCT is where cells from a healthy donor are transplanted to a patient to replace healthy cells killed during cancer treatment.
The 2-year overall survival (OS) rate was 65.8%. 45.7% of patients did not relapse after 2 years. The 2-year event-free survival (EFS; survival without complications from AML) rate was 40.2%.
Patients who had CR after CLAM treatment and allo-HSCT experienced better OS. Patients who had allo-HSCT experienced better RFS and EFS. CR after CLAM resulted in a 2-year OS rate of 84.3%. CR after allo-HSCR resulted in a 2-year OS of 90%.
Serious neutropenia (low-level white blood cells) with and without fever and thrombocytopenia (low level of platelets) occurred in all patients. There were no treatment-related deaths.
The bottom line
This study concluded that CLAM was highly effective and safe in refractory/relapsed AML.
The fine print
This study had a small number of participants and a short follow-up period. Further larger studies are needed.
Published By :
Mar 18, 2020