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Safety Profile of Midostaurin in Older Patients With AML

By: Vanessa A. Carter, BS
Posted: Wednesday, January 13, 2021

The multikinase inhibitor midostaurin has been approved as a treatment for adults with newly diagnosed FLT3-mutated acute myeloid leukemia (AML). Jorge Sierra, MD, of the Jose Carreras Leukemia Research Institute, Barcelona, and colleagues analyzed the safety of midostaurin combined with chemotherapy in patients aged 60 or older. Their findings, presented at the 2020 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 632), demonstrated the safety profile is similar for all age groups.

This phase IIIb, open-label, multicenter study enrolled 318 patients with newly diagnosed AML who were eligible for chemotherapy. All patients had an FLT3 ITD or TKD mutation and an Eastern Cooperative Oncology Group performance status of at most 2. Participants were administered either 7 + 3 100 to 200 mg/m2/day of cytarabine for 7 days plus 60 to 90 mg/m2/day of daunorubicin or 12 mg/m2/day for 3 days of idarubicin (80.4%) or a 5 + 2 reduced regimen of the same agents (19.6%). Each participant received 50 mg of midostaurin twice a day, for days 8 through 28, every 28 days, for 12 cycles.

A total of 301 patients received treatment. The median age of patients was 59, with 47.2% of participants aged 60 or older.

FLT3-ITD and FLT3-TKD mutations occurred in 82.7% and 17.6% of patients, respectively. Overall, 80.7% of participants achieved complete remission with or without incomplete hematologic recovery, regardless of age or regimen. Compared with younger patients, older patients had a higher incidence of grade 3 or greater adverse events (78.6% vs. 90.8%), serious adverse events (35.8% vs. 51.4%), adverse events leading to dose interruption or adjustment (30.2% vs. 43%), and treatment-related adverse events (73.6% vs. 78.2%). A total of 10% of participants died of their disease, most being older patients.

Disclosure: For full disclosures of the study authors, visit ash.confex.com.



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