Characterization of a multidisciplinary team’s role in hospital discharge for patients receiving hypomethylating agents with venetoclax as induction therapy for acute myeloid leukemia

Pervitsky, Vera; Guglielmo, Julie; Moskoff, Benjamin; Kneen, Roxie; Leija, Carol; Sawicky, Deborah; Krackeler, Margaret Li; Jonas, Brian A.; Beechinor, Ryan J.

doi:10.1007/s00520-023-07664-z

Cited by 1 publication

(1 citation statement)

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“…Azole agents are CYP3A4 enzyme inhibitors and are thus able to affect VEN metabolism. A reduction in the metabolism of VEN can, in turn, lead to the hyper-dosage of this drug, with a subsequent higher risk of tumor lysis syndrome (TLS), a potential complication already reported in early chronic lymphocytic leukemia trials and in the VIALE-A trial [ 14 , 46 ]. To avoid this problem, some authors suggest reducing the dose of VEN by at least 75% before starting antifungal prophylaxis [ 45 , 47 , 48 ].…”

Section: Discussionmentioning

confidence: 99%

Venetoclax with Hypomethylating Agents in Newly Diagnosed Acute Myeloid Leukemia: A Systematic Review and Meta-Analysis of Survival Data from Real-World Studies

Ucciero,

Pagnoni,

Scotti

et al. 2023

Cancers

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In recent years, the association of venetoclax (VEN) with hypomethylating agents (HMAs) significantly improved the outcome of patients with newly diagnosed acute myeloid leukemia (AML) who were unfit for intensive chemotherapy and became the standard of care after the publication of the pivotal RCT VIALE-A. However, it is still not clear to what extent the results observed in the VIALE-A apply to a real-world setting. For this reason, we carried out a systematic review and meta-analysis of real-world studies on newly diagnosed patients with AML, ineligible for intensive induction chemotherapy, receiving first-line VEN+HMA. We then compared their results in term of survival with those from the VIALE-A. Kaplan-Meier curves were extracted from all included studies and individual survival data was reconstructed. We then estimated a pooled survival curve and compared it with the results of the VIALE-A using the log-rank test. We also conducted a secondary analysis including only studies considering VEN plus azacytidine (AZA) as treatment, as this was the schedule originally used in the VIALE-A. Nineteen real-world studies met the inclusion criteria and were included in the systematic review. Most of them reported a worse survival than the VIALE-A. The pooled survival curve was similar to that reported in the VIALE-A during the first three months of treatment but diverged thereafter (p-value = 0.0001). The pooled median survival among the real-world studies was 9.37 months (95%CI 8.81–10.5), substantially lower than that reported in the VIALE-A (14.7 months; 95%CI 11.9–18.7). Results slightly increased when the analysis was restricted to the studies using VEN+AZA as treatment (median survival: 11.5 months; 95%CI 10.2–14.8). Survival of newly diagnosed AML patients treated with VEN+HMAs in a real-world setting seems to be lower than previously reported in the VIALE-A, while the effect of VEN+AZA is more in line with expected results. Future studies are needed to evaluate whether this apparent discrepancy is due to the different characteristics of enrolled patients or to a non-optimal adherence to therapy, and whether alternative regimens can provide better results in terms of safety and effectiveness.

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