Alisertib plus induction chemotherapy in previously untreated patients with high-risk, acute myeloid leukaemia: A single-arm, phase 2 trial
The Lancet Haematology Dec 18, 2019
Brunner AM, Blonquist TM, DeAngelo DJ, et al. - Researchers here investigated the activity of alisertib combined with 7 + 3 induction chemotherapy in previously untreated patients with high-risk acute myeloid leukemia. In this single-arm, phase 2 trial, patients were recruited from the Dana–Farber/Harvard Cancer Center in the USA. Patients were eligible if they had prior untreated acute myeloid leukemia, an Eastern Cooperative Oncology Group performance status of 0–2, and were at high risk of disease as marked by the presence of an adverse-risk karyotype, the presence of secondary acute myeloid leukemia originating from previous myelodysplastic syndrome or myeloproliferative neoplasm, the presence of therapy-related acute myeloid leukemia, or being 65 years or older. A total of 39 eligible patients were enrolled from Dec 31, 2015, to Aug 1, 2017. Enrolled patients were provided 7 + 3 induction chemotherapy of continuous infusion of cytarabine (100 mg/m2 per day on days 1–7) and an intravenous bolus of idarubicin (12 mg/m2 per day on days 1–3). On days 8–15, oral alisertib (30 mg) was provided twice per day. Outcomes infer the activity and safety of alisertib combined with induction chemotherapy in previously untreated patients with high-risk acute myeloid leukemia. During the median follow-up of 13·7 months, they observed composite remission in 64%, with 20 (51%) of 39 patients attaining complete remission and five (13%) attaining complete remission with incomplete neutrophil or platelet count recovery. Febrile neutropenia, neutropenia, thrombocytopenia, anorexia, and oral mucositis were the most common grade 3 or 4 adverse events.
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