Abstract
AML-310: Prognostic Value of CRh in Acute Myeloid Leukemia Treated with Venetoclax and Decitabine
Clinical lymphoma, myeloma and leukemia, Vol.21(Suppl 1), pp.S303-S304
09/2021
DOI: 10.1016/S2152-2650(21)01721-3
Abstract
Recent FDA approvals of novel therapies and hypomethylating agents/venetoclax (HMA-ven) has transformed AML therapy. CR with partial hematological recovery (CRh), defined as bone marrow blasts < 5%, ANC > 0.5×109/L, and platelet count >50×109/L, was used as a surrogate marker for efficacy due to limited data on HMA-ven. We evaluated the impact of CRh on pts treated with 10-day decitabine and venetoclax (DEC10-VEN, NCT03404193).
Patients with newly diagnosed AML aged >60 years or patients with secondary AML and antecedent hematological disorder were included. Decitabine 20 mg/m2 IV for 10 days with oral venetoclax 400 mg daily was administered for induction and decitabine (5 days) with daily venetoclax for consolidation. Responses initially recorded were complete response (CR), CR with incomplete hematologic recovery (CRi), and morphologically leukemia-free state (MLFS), according to ELN 2017 criteria. Pts who achieved CRi and MLFS were re-classified to CRh. Outcomes evaluated were overall survival (OS) and event-free survival (EFS). Full protocol and interim results have been published (DiNardo et al. Lancet Haematol. 2020;7:e724–36)
From January 2018 to February 2021, 125 patients (79 [63%] newly diagnosed, 46 [37%] secondary AML) with a median age of 71 yrs (range 48–89) were included. 69 (55%) pts achieved CR, 11 (8%) pts achieved CRh, 14 (11%) pts achieved CRi, 10 (8%) pts achieved MLFS, and 21 (17%) pts were refractory. Of the 11 CRh pts, 8 (73%) patients were previously classified as CRi and 3 (27%) as MLFS. Among pts achieving CR, the median OS was 24.5 mo, and median EFS was 18.0 mo. CRh was achieved with a median of 1 (range 1–3) cycles. Median OS of CRh vs CRi was 16.9 vs 5.8 mo (HR: 0.47, 95% CI: 0.19–1.13, p=.06), and CRh vs MLFS was 16.9 vs 6.2 mo (HR: 0.34, 95% CI: 0.13–0.93, p=.007). Median EFS of pts with CRh vs CRi was 14.1 vs 5.8 mo (HR: 0.49, 95%CI: 0.21–1.14, p=.08); CRh vs MLFS was 14.1 vs 6.2 mo (HR: 0.37, 95% CI: 0.14–1.01, p=.016). Pts achieving CRh had durable remission with a duration of response of 6.0 vs 2.5 mo with CRi and 1 mo with MLFS.
In pts with newly diagnosed and secondary AML treated with DEC10-VEN, pts achieving CRh had a trend toward improved OS and EFS compared with CRi or MLFS.
Details
- Title: Subtitle
- AML-310: Prognostic Value of CRh in Acute Myeloid Leukemia Treated with Venetoclax and Decitabine
- Creators
- Maria Siddiqui - The University of Texas MD Anderson Cancer CenterAbhishek Maiti - The University of Texas MD Anderson Cancer CenterNaval Daver - The University of Texas MD Anderson Cancer CenterTapan Kadia - The University of Texas MD Anderson Cancer CenterCaitlin Rausch - The University of Texas MD Anderson Cancer CenterYesid Alvarado - The University of Texas MD Anderson Cancer CenterMaro Ohanian - The University of Texas MD Anderson Cancer CenterKoji Sasaki - The University of Texas MD Anderson Cancer CenterNicholas Short - The University of Texas MD Anderson Cancer CenterKoichi Takahashi - The University of Texas MD Anderson Cancer CenterMusa Yilmaz - The University of Texas MD Anderson Cancer CenterFarhad Ravandi - The University of Texas MD Anderson Cancer CenterHagop Kantarjian - The University of Texas MD Anderson Cancer CenterCourtney DiNardo - The University of Texas MD Anderson Cancer CenterMarina Konopleva - The University of Texas MD Anderson Cancer Center
- Resource Type
- Abstract
- Publication Details
- Clinical lymphoma, myeloma and leukemia, Vol.21(Suppl 1), pp.S303-S304
- DOI
- 10.1016/S2152-2650(21)01721-3
- ISSN
- 2152-2650
- eISSN
- 2152-2669
- Publisher
- Elsevier Inc
- Language
- English
- Date published
- 09/2021
- Academic Unit
- Internal Medicine
- Record Identifier
- 9984920678402771
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