In a nutshell
This study aimed to investigate the safety and effectiveness of alisertib combined with induction chemotherapy in patients with high-risk acute myeloid leukemia.
This study concluded that this combination was safe and effective in these patients.
Alisertib is a type of targeted therapy called an aurora A kinase (AAK) inhibitor. It has previously been used in lymphoma. It is an experimental therapy.
In acute myeloid leukemia (AML), levels of AAK are increased. AAK leads to a multiplication of cancerous cells. Therefore, an AAK inhibitor may be useful in AML. It is not known if AAK inhibitor alisertib is safe and effective in patients with AML.
Methods & findings
This study involved 39 previously untreated patients with high-risk AML. 49% of patients had secondary AML and 8% had therapy-related AML. Patients received alisertib combined with 7+3 induction chemotherapy. 7+3 induction chemotherapy involved cytarabine (Ara-C) and idarubicin (Idamycin). The average follow-up was 13.7 months.
64% of patients achieved a remission. 51% of these achieved complete remission (CR; no signs of cancer). 13% achieved CR with incomplete neutrophil (white blood cells) or platelet count recovery.
41% of patients experienced severely low white blood cell levels and fever. 33% experienced severe thrombocytopenia (low blood platelet level). 28% of patients experienced anemia (low red blood cell count). 23% experienced loss of appetite and 10% experienced mouth sores.
The bottom line
This study concluded that alisertib combined with induction chemotherapy is safe and effective in previously untreated high-risk AML patients.
The fine print
This was a phase 2 study with a small number of participants and a short follow-up. Further larger studies are needed.
Published By :
The Lancet. Haematology
Dec 11, 2019