Venetoclax-based combinations for acute myeloid leukemia: optimizing their use in Latin-America

Objectives: Venetoclax combinations are a new standard for patients with acute myeloid leukemia (AML). We aimed to evaluate the safety and efficacy of these combinations in a period of accelerated approval in Latin-America. Methods: This observational study evaluated adults with acute myeloid leukem...

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Published in:	Hematology (Luxembourg) Vol. 27; no. 1; pp. 249 - 257
Main Authors:	Gómez-De León, Andrés, Demichelis-Gómez, Roberta, Pinedo-Rodríguez, Alfredo, Enriquez-Vera, Daniel, Flores-Jiménez, Juan Antonio, Ceballos-López, Adrián Alejandro, Rodríguez-Mejorada, Margarita, Herrera Riojas, Miguel Angel, Ovilla-Martínez, Roberto, Báez-Islas, Pamela, Cota-Rangel, Xóchitl, Neme-Yunes, Yvette, Inclán-Alarcón, Sergio, López-Flores, Nelson J., Colunga-Pedraza, Perla R., Rodríguez-Zúñiga, Anna C., Gómez-Almaguer, David
Format:	Journal Article
Language:	English
Published:	England Taylor & Francis 31-12-2022 Taylor & Francis Group
Subjects:	Acute myeloid leukemia Adult Antineoplastic Agents - pharmacology Antineoplastic Agents - therapeutic use azacytidine BCL-2 inhibitor Bridged Bicyclo Compounds, Heterocyclic - pharmacology Bridged Bicyclo Compounds, Heterocyclic - therapeutic use cytarabine Female Humans Latin America Leukemia, Myeloid, Acute - drug therapy Male Middle Aged Sulfonamides - pharmacology Sulfonamides - therapeutic use venetoclax Latin America cytarabine azacytidine venetoclax Acute myeloid leukemia BCL-2 inhibitor
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Summary:	Objectives: Venetoclax combinations are a new standard for patients with acute myeloid leukemia (AML). We aimed to evaluate the safety and efficacy of these combinations in a period of accelerated approval in Latin-America. Methods: This observational study evaluated adults with acute myeloid leukemia who received venetoclax-based therapy in 11 public or private centers in Mexico and Peru for both newly diagnosed or relapsed and refractory AML. Results: Fifty patients were included; 28 with newly diagnosed (ND) AML and 22 with relapsed/refractory (RR) disease. ND patients were older (64 vs. 40 years; p < 0.001) with a lower functional capacity (ECOG ≥2 64.3% vs 9%; p < 0.001). Venetoclax was frequently combined with azacytidine (60%) and prophylactic azoles (82%) with a median maximum dose of 200 mg (range, 100-600 mg). Hematologic toxicities were common. Complete response rates including patients with incomplete hematopoietic recovery were 78.6% in ND and 45.5% in RR patients, with a median overall survival of 9.6 (95% CI 3.7-15.5) and 8 months (95% CI 4.8-11.2). Discussion: Our study showed a preferred use of venetoclax plus azacytidine over cyatrabine. Patients in the first-line setting were similar to those in the landmark studies, while most patients with relapsed disease had received prior intensive therapies. Responses were favorable, with a median survival in agreement to other reports, albeit shorter than that observed in the randomized phase-3 trials. Conclusion: Venetoclax-based therapy in AML was effective despite dose reductions and prophylactic antifungals in two middle-income countries outside of a clinical trial setting.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1607-8454 1607-8454
DOI:	10.1080/16078454.2021.2024940