In a nutshell
This study aimed to investigate if the combination of dasatinib and decitabine was safe and effective in patients with advanced chronic myeloid leukemia.
This study concluded that this treatment is safe and effective in these patients.
Treatment of advanced-phase chronic myeloid leukemia (CML) remains unsatisfactory. Single-agent targeted therapies such as tyrosine kinase inhibitors (TKIs) are not sufficient for these patients. Dasatinib (Sprycel) is a TKI used to treat CML. Decitabine (Dacogen) is a chemotherapy used to treat myelodysplastic syndromes and acute myeloid leukemia.
It was unknown if the combination of dasatinib and decitabine was safe and effective in patients with advanced CML.
Methods & findings
This study involved 30 patients with advanced CML. 7 patients had accelerated-phase CML, 19 had blast-phase CML and 4 had Philadelphia-chromosome positive acute myeloid leukemia. Patients received a combination treatment of decitabine and dasatinib. Patients were followed up for an average of 43 months.
48% of patients achieved a major hematologic response (blood cell count returns to normal). 22% achieved a minor hematologic response. Of all patients with a hematologic response, 44% achieved a major cytogenetic response (amount of Philadelphia positive cells reduces). 33% of patients achieved a major molecular response (low level of BCR-ABL gene which is found in cancerous cells).
The average overall survival (OS) was 13.8 months. The OS was still ongoing (not reached) at follow-up for patients who achieved hematologic response compared to 4.65 months for patients who did not respond to treatment.
28 patients (93%) experienced serious blood related side effects. These included low blood cell counts. 70% of patients experienced serious non-blood related side effects such as infections or bleeding.
The bottom line
This study concluded that the combination of decitabine and dasatinib is a safe and effective regimen in advanced CML.
The fine print
This study received funding from Bristol-Myers Squibb, the manufacturer of dasatinib. This study had a very small number of participants. Further studies using this treatment combination are needed.
Published By :
American Journal of Hematology
Jul 18, 2020