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.
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Todisco Elisabetta, Papayannidis Cristina, Fracchiolla Nicola, Petracci Elisabetta, Zingaretti Chiara, Vetro Calogero, Martelli Maria Paola, Zappasodi Patrizia, Di Renzo Nicola, Gallo Susanna, Audisio Ernesta, Griguolo Davide, Cerchione Claudio, Selleri Carmine, Mattei Daniele, Bernardi Massimo, Fumagalli Monica, Rizzuto Giuliana, Facchini Luca, Basilico Claudia Maria, Manfra Ilenia, Borlenghi Erika, Cairoli Roberto, Salutari Prassede, Gottardi Michele, Molteni Alfredo, Martini Vincenza, Lunghi Monia, Fianchi Luana, Cilloni Daniela, Lanza Francesco, Abruzzese Elisabetta, Cascavilla Nicola, Rivellini Flavia, Ferrara Felicetto, Maurillo Luca, Nanni Jacopo, Romano Alessandra, Cardinali Valeria, Gigli Federica, Roncoroni Elisa, Federico Vincenzo, Marconi Giovanni, Volpi Roberta, Sciumè Mariarita, Tarella Corrado, Rossi Giuseppe, Martinelli Giovanni, AVALON Cooperative Group
Аннотация
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.