Early Real-World First-Line Treatment With Venetoclax Plus HMAs Versus HMA Monotherapy Among Patients With AML in a Predominately US Community Setting.

Autor: Gershon A; Genentech, Inc., South San Francisco, CA. Electronic address: gershon.anda@gene.com., Ma E; Genentech, Inc., South San Francisco, CA., Xu T; F. Hoffmann-La Roche Ltd, Basel, Switzerland., Montez M; Genentech, Inc., South San Francisco, CA., Naqvi K; Genentech, Inc., South San Francisco, CA., Ku G; Genentech, Inc., South San Francisco, CA., Cheng WW; AbbVie, Inc., North Chicago, IL., Flahavan EM; Roche Products Ltd., Welwyn Garden City, UK., Kota V; Georgia Cancer Center at Augusta University, Augusta, GA., Greenwald DR; University of California, Los Angeles Health Hematology Oncology, Santa Barbara, CA, USA.
Jazyk: angličtina
Zdroj: Clinical lymphoma, myeloma & leukemia [Clin Lymphoma Myeloma Leuk] 2023 May; Vol. 23 (5), pp. e222-e231. Date of Electronic Publication: 2023 Feb 11.
DOI: 10.1016/j.clml.2023.02.002
Abstrakt: Background: Venetoclax in combination with hypomethylating agents (HMAs) is standard-of-care in patients with newly diagnosed acute myeloid leukemia (AML) who are ≥ 75 years old or unfit for intensive chemotherapy. We examined early real-world treatment experience among patients with AML receiving venetoclax+HMAs or HMA monotherapy.
Patients and Methods: This retrospective cohort study used an electronic health record-derived, deidentified, United States nationwide database comprised of patient-level structured and unstructured data, curated via technology-enabled abstraction. Patients with an AML diagnosis on or after January 1, 2014, who had ≥ 2 clinic visits, and initiated treatment with venetoclax+HMAs from June 1, 2018 to March 31, 2021, or HMA monotherapy from January 1, 2016 to May 31, 2018, were included. Kaplan-Meier analysis was used to estimate time to last administration (TTLA) and overall survival (OS).
Results: Overall, 619 patients treated with venetoclax+HMAs and 480 treated with HMA monotherapy were selected from the database. Median age at diagnosis was 76 and 78 years, respectively, most patients were treated in community practice (83.4% and 89.4%, respectively), and almost half had secondary AML (47.2% and 47.3%, respectively). Adjusted analyses showed both significantly longer TTLA (3.6 months vs. 2.3 months; hazard ratio [HR] = 0.69 [95% confidence interval (CI), 0.60-0.80], P< .0001) and OS (9.3 months vs. 5.9 months; HR = 0.71 [95% CI, 0.61-0.82], P < .0001) in patients treated with venetoclax+HMAs versus HMA monotherapy, respectively.
Conclusion: This study shows benefit in real-world outcomes of venetoclax+HMAs relative to HMA monotherapy in patients with newly diagnosed AML, using a predominantly community-based database.
Competing Interests: Disclosure AG, EM, MM, KN, GK: Genentech, Inc (E); F. Hoffmann-La Roche Ltd (OI). TX, EMF: F. Hoffmann-La Roche Ltd (E/OI). WWHC: AbbVie, Inc (E) VK: Incyte, Inc. (RF); Pfizer, Inc., Novartis, Inc (C/A). DRG: Genentech, Inc./F. Hoffmann-La Roche Ltd (C/A); ADC Therapeutics, Jazz Pharmaceuticals, Genentech, Inc./F. Hoffmann-La Roche Ltd. (Other: speakers’ bureau); Bristol Myers Squibb (SAB).
(Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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