<i>Evaluation of 5-Day Vs. 10-Day Decitabine in Combination with Venetoclax in Newly Diagnosed AML Patients Ineligible for Induction Chemotherapy</i>

Pérez, Julie; Tinajero, Jose; Ngo, Dat; Zhang, Jianying; Koller, Paul; Agrawal, Vaibhav; Pourhassan, Hoda; Malki, Monzr M. Al; Salhotra, Amandeep; Ali, Haris; Aribi, Ahmed; Sandhu, Karamjeet S.; Arslan, Shukaib; Otoukesh, Salman; Amanam, Idoroenyi; Artz, Andrew S.; Becker, Pamela S.; Stewart, Forrest; Smith, Eileen; Curtin, Peter T.; Forman, Stephen J.; Nakamura, Ryotaro; Pullarkat, Vinod; Marcucci, Guido; Stein, Anthony S.; Aldoss, Ibrahim; Ball, Brian

doi:10.1182/blood-2022-170867

Cited by 2 publications

(1 citation statement)

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“…Here, therapy with VEN-AZA also resulted in a trend towards longer OS compared to VEN-DEC (25 months vs. 5.4 months; p = 0.13) (31). One reason for the poor performance of VEN-DEC observed in our analysis might have also been the 5-day schedule employed for DEC, since pharmacodynamic evidence suggests that a 10-day schedule, by increasing the exposure of AML blasts to DEC, may produce high response rates as shown in a phase I and a phase II trial in R/R AML (40)(41)(42). Noteworthy, as reported in a retrospective study by Maiti et.…”

Section: Discussionmentioning

confidence: 70%

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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