Dp026 | Outpatient Vs Inpatient Management of Hma-ven Treated Patients: Hospitalization During the First Cycle Is Needed? a Retrospective, Multicentric Experience.
Year: 2025
Type: article
Abstract: The combined therapy of hypomethylating agents (HMA) and venetoclax (VEN) has become the standard of care for chemotherapy-ineligible acute myeloid leukemia (AML) patients.Despite the lack of evidence, hospitalization is recommended for at least the first cycle of therapy.We retrospectively collected data from seven centers in North-Eastern Italy, aiming to evaluate the impact of outpatient and inpatient management during induction of HMA-VEN treatment in terms of cumulative infection (cIR) and first-cycle (1°cIR) infection rate, complications-related hospitalization rate (cHR), non-relapse early mortality rate within the first two months (NR-EMR) and overall survival (OS). We report on 241 patients affected by AML, treated frontline (FL,n=175) or at relapse (RR, n=66) with HMA-VEN, who completed at least one cycle of therapy. The median follow-up for the entire cohort was 25.8 months (range 1-61.8). One-hundred-thirty-six patients (56.4%) received the first cycle as inpatient (IN) whereas 105 (44.6%) were treated as outpatient (OUT). Patients' clinical characteristics and outcomes are resumed in Table 1. Of note, 71(52.2%) patients in the IN group and 44 (41.9%) in the OUTgroup received fluoroquinolones prophylaxis. TLS incidence was low and similar in the two groups [IN = 2.2% (3/136) vs OUT = 2.9% (3/105)]. During the first cycle, 20 out of 105 OUT pts (19%) required hospitalization for complications. One of these patients had fatal septic shock, while 3 patients died within 2 months from subsequent infective or hemorrhagic complications that occurred during hospitalization. The other 16 patients had a full recovery and proceeded with at least another cycle. Median OS was comparable between the two groups (IN 12.7 vs OUT 14 months, p=0.3). Univariate analysis showed a relevant difference in terms of 1°cIR [52.9% (72/136) vs. 33.3% (35/105); p=0.002] while overall cIR was similar [75% (102/136) vs 70.6% (77/105), p=0.4] for IN and OUT group, respectively. In all cycles, cHR was 39 % (n=41/105) in the OUT group vs 28.7% (n=39/136) in the IN group (p=0.09). NR-EMR did not differ significantly [IN= 2.2% (3/136) vs OUT= 5.7% (6/105); p=0.1]. Similarly, all-causes EMR was comparable [IN= 16.9% (23/136) vs OUT= 19% (20/105); p=0.6]. To our knowledge, this is the largest retrospective study on the topic. As suggested in previous papers, these data highlight the safety of outpatient management during the induction phase of patients receiving HMA-VEN therapy.
Authors: E. Tamellini, E. Marchetti, C. Ancora, F. Angotzi, D. Facchinelli, F. Capraro, G. Battaglia, A. Sperotto, M. Gottardi, M. Tiribelli, M. Leoncin, E. De Bellis, C. Gurrieri
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7093123533
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