Trial eligibility, treatment patterns and outcome for venetoclax-based therapy in AML: a prospective cohort study.

Autor:	Wolach O; Institute of Hematology, Davidoff Cancer Center, Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel., Levi I; Soroka, Beer Sheva, Israel., Nachmias B; Hadassah Hebrew University Hospital, Jerusalem, Israel., Tavor S; Assuta Medical Center, Tel-Aviv, Israel., Amitai I; 6. Hematology Division, Chaim Sheba Medical Center, Ramat Gan, Israel., Ofran Y; Sharee Zedeq medical center, Jerusalem, Israel., Ganzel C; The Hematology department, Shaare Zedek Medical Center, Israel; Faculty of Medicine, Hebrew University of Jerusalem, Israel, Jerusalem, Israel., Zuckerman T; Rambam Health Care Campus, Technion B. Rappaport faculty of medicine, Haifa, Israel., Okasha D; Hematology Unit, Ha'Emek Medical Center, Afula, Israel., Hellmann I; Hematology Unit, Meir Medical Center, Kfar Saba, Israel., Tadmor T; Bnai Zion Medical Center, Haifa, Israel., Dally N; Ziv Medical Center, Zefat, Israel., Canaani J; Weill Medical College of Cornell University, New York, New York, United States., Stemer G; Galilee Medical Center, Nahariya, Israel., Grunspan M; AbbVie Inc, Hod-Hasharon, Israel., Berger AJ; AbbVie Inc, Hod-Hasharon, Israel., Frankel N; AbbVie Inc, Hod-Hasharon, Israel., Berelovich J; AbbVie Inc, Hod-Hasharon, Israel., Bleterman A; AbbVie Inc, Hod-Hasharon, Israel., Barak M; AbbVie Inc, Hod-Hasharon, Israel., Cohen R; AbbVie Inc, Hod-Hasharon, Israel., Moshe Y; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Jazyk:	angličtina
Zdroj:	Blood advances [Blood Adv] 2024 Dec 05. Date of Electronic Publication: 2024 Dec 05.
DOI:	10.1182/bloodadvances.2024014014
Abstrakt:	Venetoclax (Ven) plus hypomethylating agents are considered standard-of-care for patients with acute myeloid leukemia (AML) judged ineligible for intensive chemotherapy (IC). Real-world studies complement clinical trials, since patterns of patient selection, treatment-exposure and post-remission management may vary. This prospective observational multi-center study included 209 newly diagnosed IC-ineligible patients with a median age 75 years (interquartile range, 71-81 years). A high proportion of patients had secondary AML (53.7%), adverse-risk disease (35.3%), and complex karyotype (15.5%). At a median follow-up of 22.5 months (range 0.1-43), median overall-survival (mOS) was 11.7 months (95% Confidence Interval [CI] 9.9,15.4). Composite complete remission (CRc) was achieved in 65.2% (CR 44.4%; CRi 20.8%). Of responding patients, 21.1% underwent stem-cell transplantation. When stratified based on VIALE-A original eligibility criteria, mOS was 17.8 months for patients meeting eligibility criteria and 10.7 months for patients who did not (p=0.027). AML ontogeny (p=0.024), reduced kidney function (p=0.001), Charlson co-morbidity index (CCI; p=0.0017), ELN-risk (p=0.01) and body-mass index (p=0.0298) were significantly associated with OS. Multivariant Cox-regression analysis confirmed independent association of OS with AML ontogeny (p=0.012), CCI (p=0.033) and ELN-risk (p=0.019). Patients enrolled in the latter half of the study period demonstrated improved OS compared to those enrolled earlier (p=0.026). This prospective observational study highlights outcomes of patient subgroups, including those excluded from registration trials. (clinicaltrials.gov: #NCT03987958). (Copyright © 2024 American Society of Hematology.)
Databáze:	MEDLINE
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