Safety and Feasibility of Outpatient Liposomal Daunorubicin and Cytarabine (Vyxeos) Induction and Management in Patients with Secondary AML

▪ Introduction: Liposomal daunorubicin and cytarabine (Vyxeos®) improves overall survival and remission rates compared to conventional daunorubicin and cytarabine (7+3) induction in older patients with secondary acute myeloid leukemia (AML). The safety profiles are similar, despite prolonged time to neutrophil and platelet count recovery with liposomal daunorubicin and cytarabine (Lancet et al, JCO 2018). There are other potential benefits of the liposomal combination, such as the feasibility of outpatient (OP) administration which can improve patient satisfaction and healthcare costs. Herein we show preliminary results of a pilot program based on OP liposomal daunorubicin and cytarabine administration to safely decrease inpatient (IP) days, with close OP monitoring throughout treatment phase until recovery. Methods: The objective of this study is to compare the IP hospital days between patients induced with liposomal daunorubicin and cytarabine in the Inpatient/Outpatient (IPOP) program vs. IP setting. The IPOP program involves administration of chemotherapy and close monitoring of patients in the OP setting who receive traditionally IP chemotherapy regimens. All patients received liposomal daunorubicin and cytarabine induction at a dose of daunorubicin 44 mg/m2 and cytarabine 100 mg/m2 via intravenous infusion over 90 minutes on days 1, 3 and 5. Patients were excluded for IPOP liposomal daunorubicin and cytarabine if they had signs or symptoms of active infection, cardiopulmonary disease, at risk for tumor lysis syndrome, ECOG > 2 or did not have an appropriate caregiver or transportation to the cancer center. Eligible patients received liposomal daunorubicin and cytarabine in the IPOP program and were monitored at least every other day until count recovery. Patients who developed complications such as febrile neutropenia were hospitalized with the goal of de-escalating antibiotic therapy and when appropriate, discharged to IPOP for continued care. Ineligible patients for IPOP treatment received IP liposomal daunorubicin and cytarabine induction and discharged to OP care prior to count recovery if clinically appropriate. A t-test of unequal variance was utilized to determine statistical significance between number of IP days between IPOP and IP groups. Results: Over the study period, 12 patients received induction therapy with liposomal daunorubicin and cytarabine. Seven patients (58%) received IPOP induction and 5 received IP induction (Median age: 72,