Posted: Thursday, June 17, 2021
At the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 7007), Jessica K. Altman, MD, of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, and colleagues presented their results on the safety and efficacy of aspacytarabine—a prodrug of cytarabine—as a first-line therapy for acute myeloid leukemia (AML). The investigators suggested that this therapy is, in fact, safe and effective for patients who are unable to receive standard chemotherapy, deeming it a “new tolerable AML chemotherapy backbone.”
This phase IIb, open-label study enrolled 46 patients with newly diagnosed AML who were unfit for standard chemotherapy. Participants who were eligible had secondary AML, therapy-related AML, and prior hypomethylating agent therapy. Patients received 4.5 g/m2/day of aspacytarabine in one to two induction courses and one to three consolidation courses.
The median patient age was 75 years; 63% of patients had de novo AML, and the remaining individuals had secondary AML. Six patients underwent previous hypomethylating agent therapy. With baseline median bone marrow blasts of 52%, 54% of patients had an adverse European LeukemiaNet score, and 29% had an intermediate score; 43% of patients had an Eastern Cooperative Oncology Group score of 2.
A majority of drug-related adverse events greater than grade 2 were infections and hematologic events, and the 30-day mortality rate was 11%. A total of 15 patients reached complete remission and hematologic recovery following one or two induction courses. Of the 43 patients evaluable for treatment efficacy, the complete remission rate was 39%; all of these patients had complete hematologic recovery in a median of 28 days. Of those complete responders who were evaluable for measurable residual disease, 63% were negative. The median overall survival and median duration of response among those with a complete remission were not reached at the time of this presentation.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.