Venetoclax with Decitabine Versus Decitabine Monotherapy in Elderly Acute Myeloid Leukemia: A Propensity Score Matched Analysis

Kwag, Daehun; Bang, Su Yeon; Lee, Jong Hyuk; Min, Gi June; Park, Silvia; Yoon, Jihyun; Lee, Sung‐Eun; Eom, Ki‐Seong; Kim, Yoo-Jin; Lee, Seok; Kim, Hee-Je; Min, Chang‐Ki; Cho, Seok-Goo; Lee, Jong Wook; Cho, Byung-Sik

doi:10.1182/blood-2022-171105

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“…Based on these results, this combination has become a standard of care for newly diagnosed AML patients unfit for induction chemotherapy. Although a direct comparison in a randomized phase III trial is lacking, the association of VEN with DEC showed superiority when compared to DEC monotherapy in a propensity score-matched analysis, yielding an estimated median OS of 13.4 months vs. 8.3 months, and response rates of 70.3% vs. 24.3% for VEN-DEC and DEC respectively (15). These results unveiled the attractive possibility of testing VEN in association with HMAs in R/R AML.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of venetoclax plus hypomethylating agents in relapsed/refractory acute myeloid leukemia: a multicenter real-life experience

Angotzi,

Lessi,

Leoncin

et al. 2024

Front. Oncol.

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Venetoclax (VEN) has been shown to play a synergistic effect in combination with hypomethylating agents (HMAs) in the frontline treatment of acute myeloid leukemia (AML). However, the potential role of this therapy in the relapsed/refractory (R/R) AML setting, still needs to be further unveiled. The aim of the current study was to retrospectively outline the safety profile, response and survival outcomes of R/R AML patients treated with VEN in association with HMAs. Clinical, biological, and molecular data were collected from 57 patients with R/R AML treated with VEN combined with azacitidine or decitabine between 2018 and 2023. The median age of patients was 63 years, 38 (66.7%) received treatment for relapsed disease while 19 (33.3%) for refractory disease, 5 (8.7%) were treated for molecular relapse. A consistent proportion of the cohort was represented by patients with unfavorable prognostic factors such as complex karyotype (36.8%), secondary AML (29.8%), previous exposure to HMAs (38.6%), and relapse after allogeneic stem cell transplant (22.8%). A total of 14 patients achieved CR (24.6%), 3 (5.3%) CRi, 3 (5.3%) MLFS, and 3 (5.3%) PR, accounting for an ORR of 40.4%. The CR/CRi rate was higher in the group treated with azacitidine than in the group treated with decitabine (37.8% vs. 15%). The median OS was 8.2 months, reaching 20.1 months among responding patients. VEN-HMAs treatment allowed to bridge to allogeneic stem cell transplantation 11 (23.9%) of eligible patients, for which a median OS of 19.8 months was shown. On multivariate analysis, ECOG performance status ≥2, complex karyotype and not proceeding to allogeneic stem cell transplantation after therapy with VEN-HMAs were the factors independently associated with shorter OS. Patients treated with the azacitidine rather than the decitabine containing regimen generally displayed a trend toward superior outcomes. The major toxicities were prolonged neutropenia and infections. In conclusion, this study showed how VEN-HMAs could represent an effective salvage therapy in patients with R/R AML, even among some of those patients harboring dismal prognostic features, with a good toxicity profile. Further prospective studies are thus warranted.

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Section: Introductionmentioning

confidence: 99%