1. Venetoclax-based combinations for acute myeloid leukemia: optimizing their use in Latin-America.
- Author
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Gómez-De León A, Demichelis-Gómez R, Pinedo-Rodríguez A, Enriquez-Vera D, Flores-Jiménez JA, Ceballos-López AA, Rodríguez-Mejorada M, Herrera Riojas MA, Ovilla-Martínez R, Báez-Islas P, Cota-Rangel X, Neme-Yunes Y, Inclán-Alarcón S, López-Flores NJ, Colunga-Pedraza PR, Rodríguez-Zúñiga AC, and Gómez-Almaguer D
- Subjects
- Adult, Antineoplastic Agents pharmacology, Bridged Bicyclo Compounds, Heterocyclic pharmacology, Female, Humans, Latin America, Male, Middle Aged, Sulfonamides pharmacology, Antineoplastic Agents therapeutic use, Bridged Bicyclo Compounds, Heterocyclic therapeutic use, Leukemia, Myeloid, Acute drug therapy, Sulfonamides therapeutic use
- Abstract
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.
- Published
- 2022
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