Implementation of a High-Dose Cytarabine Outpatient Program for Acute Myeloid Leukemia Patients in a Limited-Source Setting

Background: The management of acute myeloid leukemia (AML) patients usually requires long inpatient treatments that can affect the limited care facilities, the quality of life, and increases healthcare costs. Additionally, leukemia treating centers in developing countries face limited sources to deliver high-dose chemotherapies as inpatient treatments. Therefore, several reports have established the feasibility and safety of outpatient consolidation. We aimed to implement a high-dose cytarabine outpatient program for AML in a limited-source institution at a public center in Peru.Methods: We conducted a prospective pilot study starting in January 2019 and ending before the COVID-19 Pandemic in March 2020. Eligible patients were ≥ age 14, met inclusion criteria for inpatient induction regimens, were without active infection, and had the following: normal chest x-ray and biochemistry, complete remission after one cycle of 7+3 induction. Logistical requirements included a 3-hours distance residence near the treatment center, caregiver support, trained nursing staff, infusion room capacity, and participation in follow-up. Patients received prophylactic antimicrobials such as oral levofloxacin, fluconazole, and acyclovir and were admitted to the hospital for predetermined complications of therapy (fever, G3-4 toxicity, febrile neutropenia, bleeding or refractory thrombocytopenia). Risk stratification was based on conventional cytogenetics and multiplex PCR using Leukemia.net criteria.

Results: Forty-two patients were included during the study period. The median age was 38 years (16-63) and Female/Male ratio 4:3. According to Leukemia.net, 24% were classified as high, 50% intermediate and 26% as low risk group. Including FLT3 mutations in 26% of cases. Twenty-two and 20 subjects received 1-2 and 3-4 cycles of ambulatory HiDAC, respectively. About one-third of cases had emergency admissions during consolidation and 74% complete at least 3 cycles of cytarabine. Only 4 patients underwent sibling-donor allo-SCT. Sixty-four percent experienced relapses, and at 2 years follow-up only 21 subjects were alive. Median OS was 15 months, a better survival was shown among patients who received 3-4 cycles of ambulatory HiDAC (2-year OS 18 vs 23%, p=0.031).

Conclusion: Our pilot study shows the feasibility to deliver HiDAC as outpatient consolidation in selected AML cases in a limited setting. Additionally, a high rate of relapses and poor survival was noted in our cohort that requires further consideration.