P053 | SURVEY OF THE VERO STUDY SITES FOR AML TREATMENT WITH VENETOCLAX PLUS AZACITIDINE IN ITALY

BACKGROUND: In patients with newly diagnosed acute myeloid leukemia (AML) ineligible for intensive chemotherapy (IC), the combination of Venetoclax (VEN) with hypomethylating agents (azacitidine-Aza or decitabine) represents the cornerstone of the current treatment strategy. OBJECTIVE: The study aimed to collect real-world data on the management of AML patients ineligible for IC in Italian hematologic centers using VEN+Aza regimen. METHODS: A structured questionnaire was completed, through eCRF from Mar to Dec 2024,by the 28 sites participating in the VERO observational study across Italy (15 hospitals, 10 academic and 3 referral sites-IRCCS), consisting of 24 items, some with branched logic, divided into distinct sections: center characteristics, patient management, antifungal prophylaxis, routine VEN pre-treatment tests , approaches to diagnosis and management of adverse events (AEs), use of G-CSF, assessment of patients' quality of life and availability of home care services. RESULTS: Table 1 shows the survey results. All 28 sites report having consolidated experience in using VEN, regardless of the type of facility. The mean number of new diagnoses/year (38.1, median=35), the overall available hospital beds (21.4) together with the share (47.6%) dedicated to these patients indicate the high impact of AML on the daily practice. Patients are managed as outpatient in 39% of cases, while in 7% as an inpatient whereas in 54% by a mixed approach. Eighty-two % of the sites routinely use antifungal prophylaxis (mainly Posaconazole). Twenty-one % of the centers routinely perform a total body CT scan while 89% of the centers perform a complete cardiological screening (ECG and echocardiogram) before starting the treatment. G-CSF is used in 75% of the centers, but mainly in case of febrile neutropenia and/or severe neutropenia (19 sites), and as prophylaxis (6 sites). A TLS screening panel as per SmPC is performed in 86% of cases and a complete diagnostic work-up for febrile events is conducted by 86% of participants. CONCLUSION: The data show notable variability in the pre-treatment screening methods and in the management of AEs. Indeed, a considerable heterogeneity has been detected in the use of antifungal prophylaxis and G-CSF, highlighting a lack of uniformity in center-approach. In addition, few centers evaluate patients' quality of life at baseline and are supported by home care services, indicating the need to integrate this aspect into treatment paths.

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SHILAP Revista de lepidopterología
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2025-09-01
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Bariatric Surgery and Outcomes
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article

P053 | SURVEY OF THE VERO STUDY SITES FOR AML TREATMENT WITH VENETOCLAX PLUS AZACITIDINE IN ITALY

SHILAP Revista de lepidopterología
Bariatric Surgery and Outcomes
article

P053 | SURVEY OF THE VERO STUDY SITES FOR AML TREATMENT WITH VENETOCLAX PLUS AZACITIDINE IN ITALY

article en

Abstract

BACKGROUND: In patients with newly diagnosed acute myeloid leukemia (AML) ineligible for intensive chemotherapy (IC), the combination of Venetoclax (VEN) with hypomethylating agents (azacitidine-Aza or decitabine) represents the cornerstone of the current treatment strategy. OBJECTIVE: The study aimed to collect real-world data on the management of AML patients ineligible for IC in Italian hematologic centers using VEN+Aza regimen. METHODS: A structured questionnaire was completed, through eCRF from Mar to Dec 2024,by the 28 sites participating in the VERO observational study across Italy (15 hospitals, 10 academic and 3 referral sites-IRCCS), consisting of 24 items, some with branched logic, divided into distinct sections: center characteristics, patient management, antifungal prophylaxis, routine VEN pre-treatment tests , approaches to diagnosis and management of adverse events (AEs), use of G-CSF, assessment of patients' quality of life and availability of home care services. RESULTS: Table 1 shows the survey results. All 28 sites report having consolidated experience in using VEN, regardless of the type of facility. The mean number of new diagnoses/year (38.1, median=35), the overall available hospital beds (21.4) together with the share (47.6%) dedicated to these patients indicate the high impact of AML on the daily practice. Patients are managed as outpatient in 39% of cases, while in 7% as an inpatient whereas in 54% by a mixed approach. Eighty-two % of the sites routinely use antifungal prophylaxis (mainly Posaconazole). Twenty-one % of the centers routinely perform a total body CT scan while 89% of the centers perform a complete cardiological screening (ECG and echocardiogram) before starting the treatment. G-CSF is used in 75% of the centers, but mainly in case of febrile neutropenia and/or severe neutropenia (19 sites), and as prophylaxis (6 sites). A TLS screening panel as per SmPC is performed in 86% of cases and a complete diagnostic work-up for febrile events is conducted by 86% of participants. CONCLUSION: The data show notable variability in the pre-treatment screening methods and in the management of AEs. Indeed, a considerable heterogeneity has been detected in the use of antifungal prophylaxis and G-CSF, highlighting a lack of uniformity in center-approach. In addition, few centers evaluate patients' quality of life at baseline and are supported by home care services, indicating the need to integrate this aspect into treatment paths.

SHILAP Revista de lepidopterología
University of Modena and Reggio Emilia (IT), Università degli Studi del Piemonte Orientale “Amedeo Avogadro” (IT), Humanitas University (IT), Policlinico Umberto I (IT), Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT), AbbVie (United States) (US), Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT), Ospedale Antonio Cardarelli (IT), Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (IT), Azienda Ospedaliera Universitaria Integrata Verona (IT), Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IT), Azienda ospedaliera "Bianchi-Melacrino-Morelli" (IT), Ospedale Vincenzo Cervello (IT), Ospedale Papa Giovanni XXIII (IT), Ospedali Riuniti di Ancona (IT), Ospedale di Santo Spirito (IT), Azienda Ospedaliero Universitaria Ospedali Riuniti (IT), Azienda Ospedaliero-Universitaria Careggi (IT), Ospedale Santa Maria (IT), Azienda Ospedaliero Universitaria Maggiore della Carita (IT), Azienda Ospedaliero-Universitaria Cagliari (IT), Ospedale di Circolo di Busto Arsizio (IT), Ospedale di Belcolle (IT), Policlinico Universitario di Catania (IT), Ospedali Riuniti San Giovanni di Dio e Ruggi d'Aragona (IT), ​Advanced Systems Technology (United States) (US), Policlinico Tor Vergata (IT), Ospedale Policlinico San Martino (IT), Policlinico San Matteo Fondazione (IT), Ospedale Vito Fazzi (IT), Azienda Sanitaria Universitaria Integrata di Trieste (IT)
Openalex Percentile: Top 33%
Bariatric Surgery and Outcomes
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