Session: 615. Acute Myeloid Leukemias: Commercially Available Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster II
Hematology Disease Topics & Pathways:
Acute Myeloid Malignancies, AML, Combination therapy, Diseases, Therapies, Adverse Events, Myeloid Malignancies
Methods Data of patients with MPN-BP and AML-MDS treated frontline with HMA+VEN in 20 hematological Italian Centers outside clinical trials were retrospectively collected and analysed. Patients treated with HMA + VEN as salvage therapy after induction failure/relapse were excluded. Composite overall response rate [ORR; complete remission (CR) + CR with incomplete hematologic recovery (iCR) + partial remission (PR) + hematological improvement (HI)], duration of response and overall survival (OS) were assessed.
Results: A total of 64 patients (41 MPN-BP and 23 AML-MDS) treated between 11/2018 and 5/2022 were included. Baseline characteristics at evolution and starting treatment for the whole cohort and according to previous disease are reported in the Table 1. Median interval from initial MPN/MDS diagnosis to evolution was 31.5 months [interquartile range (IQR) 16.0 – 108.1] in the entire cohort [42.0 months (IQR 22.0 – 124.9) in MPN-BP and 18.8 months (IQR 10.9 – 39.8) in AML-MDS]. Patients were treated for a median of 2 courses (IQR 2-6): HMA were administered at standard dosage, VEN daily dose in the 1st cycle was 50 mg in 6 patients (9.4%), 100 mg in 27 patients (42.2%), 200 mg in 8 patients (12.5%) and 400 mg in 23 patients (35.9%), respectively. On the whole, 50/64 patients (78.1%) had at least one hematological toxicity of grade 3-4: in particular, severe neutropenia (PMN < 0.5 x 109/l) was reported in 46 patients (71.8%). Twenty-nine patients (45.3%) had at least one infective episode during the treatment: pulmonary infections were reported in 18 patients (28.1%). Response to treatment is shown in the Table 1: ORR was 60.0% (60.5% in MPN-BP and 59.1% in AML-MDS, respectively). Median response duration of the whole cohort was 5.3 months (95%CI 2.2-8.4), without significant differences in MPN-BP and AML-MDS patients [4.8 (95%CI 3.2 – 6.5) and 7.8 (95%CI 2.8 – 12.8) months, respectively (p=0.467)]. After a median follow-up of 6.1 months (IQR xx – xx) from the start of combined regimen, 37 patients (57.8%) died, 2 (3.1%) were lost to follow-up and 25 (39.1%) were alive. Median overall survival (OS) of the whole cohort was 7.2 months (95%CI 4.8-9.7), without differences between MPN-BP and AML-MDS groups [8.0 (95%CI 5.0 – 10.9) and 6.8 (95%CI 4.3 – 9.3) months, respectively (p=0.717, Figure 1)]. Patients with any type of response to the combination regimen had a significantly longer OS compared to patients with progressive/stable disease [11.6 (95%CI 8.2 – 14.9) and 5.4 (95%CI 2.8 – 7.9) months, respectively (p=0.006)].
Conclusions: Our real-life data confirm that HMA + VEN combination could have a role in these two very challenging subsets of secondary AML, with achievement of ORR > 50% in patients unfit for intensive approaches: however, this treatment is affected by severe hematological and infective toxicities and the response duration is short, leading to a persistently poor median OS. Larger cohorts of patients and a longer follow-up are needed to assess factors predictive of CR/iCR achievement, while the addition of other targeted therapies should be explored.
Disclosures: Latagliata: BMS: Honoraria; Novartis: Honoraria. Abruzzese: BMS, Incyte, Novartis, Pfizer: Consultancy. Binotto: Novartis, BMS, Incyte, Pfizer: Honoraria. Crugnola: Amgen: Speakers Bureau; Novartis: Speakers Bureau. Curti: Jazz Pharma: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees.
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