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. 2023 Apr 1;129(7):992-1004.
doi: 10.1002/cncr.34608. Epub 2023 Jan 24.

AVALON: The Italian cohort study on real-life efficacy of hypomethylating agents plus venetoclax in newly diagnosed or relapsed/refractory patients with acute myeloid leukemia

Elisabetta Todisco  1   2 , Cristina Papayannidis  3 , Nicola Fracchiolla  4 , Elisabetta Petracci  5 , Chiara Zingaretti  5 , Calogero Vetro  6 , Maria Paola Martelli  7 , Patrizia Zappasodi  8 , Nicola Di Renzo  9 , Susanna Gallo  10 , Ernesta Audisio  11 , Davide Griguolo  12 , Claudio Cerchione  13 , Carmine Selleri  14 , Daniele Mattei  15 , Massimo Bernardi  16 , Monica Fumagalli  17 , Giuliana Rizzuto  18 , Luca Facchini  19 , Claudia Maria Basilico  20 , Ilenia Manfra  21 , Erika Borlenghi  22 , Roberto Cairoli  23 , Prassede Salutari  24 , Michele Gottardi  25 , Alfredo Molteni  26 , Vincenza Martini  27 , Monia Lunghi  28 , Luana Fianchi  29 , Daniela Cilloni  30 , Francesco Lanza  31 , Elisabetta Abruzzese  32 , Nicola Cascavilla  33 , Flavia Rivellini  34 , Felicetto Ferrara  35 , Luca Maurillo  36 , Jacopo Nanni  3 , Alessandra Romano  6 , Valeria Cardinali  7 , Federica Gigli  1 , Elisa Roncoroni  8 , Vincenzo Federico  9 , Giovanni Marconi  13 , Roberta Volpi  5 , Mariarita Sciumè  4 , Corrado Tarella  1 , Giuseppe Rossi  22 , Giovanni Martinelli  13 ; AVALON Cooperative Group
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Free article

AVALON: The Italian cohort study on real-life efficacy of hypomethylating agents plus venetoclax in newly diagnosed or relapsed/refractory patients with acute myeloid leukemia

Elisabetta Todisco et al. Cancer. .
Free article

Abstract

Background: Venetoclax in combination with hypomethylating agents (HMA) is revolutionizing the therapy of acute myeloid leukemia (AML). However, evidence on large sets of patients is lacking, especially in relapsed or refractory leukemia.

Methods: AVALON is a multicentric cohort study that was conducted in Italy on patients with AML who received venetoclax-based therapies from 2015 to 2020. The study was approved by the ethics committee of the participating institution and was conducted in accordance with the Declaration of Helsinki. The effectiveness and toxicity of venetoclax + HMA in 190 (43 newly diagnosed, 68 refractory, and 79 relapsed) patients with AML are reported here.

Results: In the newly diagnosed AML, the overall response rate and survival confirmed the brilliant results demonstrated in VIALE-A. In the relapsed or refractory AML, the combination demonstrated a surprisingly complete remission rate (44.1% in refractory and 39.7% in relapsed evaluable patients) and conferred to treated patients a good expectation of survival. Toxicities were overall manageable, and most incidents occurred in the first 60 days of therapy. Infections were confirmed as the most common nonhematologic adverse event.

Conclusions: Real-life data show that the combination of venetoclax and HMA offers an expectation of remission and long-term survival to elderly, newly diagnosed patients, and to relapsed or chemoresistant AML, increasing the chance of cure through a different mechanism of action. The venetoclax + HMA combination is expected to constitute the base for triplet combinations and integration of target therapies. Our data contribute to ameliorate the understanding of venetoclax + HMA effectiveness and toxicities in real life.

Keywords: acute myeloid leukemia; hypomethylating agents; real-life data; relapsed and refractory AML; venetoclax.

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References

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