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Conducted in a real-world clinical setting with 48 patients treated with VEN plus azacytidine, showing substantial inter- and intra-individual plasma concentration variability. Higher VEN concentrations correlated with improved hematological responses, with median overall survival of 17.8 months and 1-/2-year survival rates of 51%/36.4%. Comparing 14-day versus 28-day VEN protocols indicates longer exposure improved benefit without increasing toxicities, supporting TDM to balance efficacy and safety.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/predicting-the-toxicity-efficacy-ratio-of-venetoclax-in-real-world-patients/430174/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/predicting-the-toxicity-efficacy-ratio-of-venetoclax-in-real-world-patients/430174.png","ImageObject",300,407,{"name":92,"@type":93},"River Wang","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-11-08","2026-09-29",true,{"@type":102,"interactionType":103,"userInteractionCount":34},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"Who were included in the study and what treatment did they receive?","Question",{"text":112,"@type":113},"The study enrolled 48 adult AML patients ineligible for intensive chemotherapy. All patients received Venetoclax (VEN) in combination with azacytididine in a real-world clinical setting.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How did VEN plasma exposure relate to treatment response and survival?",{"text":117,"@type":113},"Higher VEN plasma concentrations were associated with better hematological responses. The median overall survival was 17.8 months, with 1-year and 2-year survival rates of 51% and 36.4%, respectively.",{"name":119,"@type":110,"acceptedAnswer":120},"What was the difference between the 14-day and 28-day VEN protocols?",{"text":121,"@type":113},"Patients benefited from longer treatment durations, resulting in more courses administered. Plasma concentrations in the 14-day protocol were higher than in the 28-day protocol without an increase in toxicities.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},430174,1790792337,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":34,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":145,"preview_page_count":4},1099514067438,"https://ap-avatar.wpscdn.com/avatar/100002539ee87300030?x-image-process=image/resize,m_fixed,w_180,h_180&k=1780474512215547542","Annals of Hematology (2025) 104:6327–6337  \n[https://doi.org/10.1007/s00277-025-06531-7](https://doi.org/10.1007/s00277-025-06531-7)  \nRESEARCH  \nPredicting the toxicity-efficacy ratio of venetoclax in real-world patients  \nLoïc Osanno1,2 · Lucy Brocque1 · Laurent Bourguignon3,4 · Carla Delpech1 · Laure Farnault5 · Julien Colle5 · Pauline Roche5 · Jacques Chiaroni6,8 · Caroline Izard6,8 · Régis Costello5 · Mathilde Dacos1,2 · Caroline Solas9 · Chems Djezzar11 · Joseph Ciccolini2,7 · Thomas Cluzeau12 · Geoffroy Venton5,10 · Raphaëlle Fanciullino1,2  \nReceived: 9 December 2024 / Accepted: 21 July 2025 / Published online: 11 December 2025 © The Author(s) 2025  \nAbstract  \nThis study investigates the pharmacokinetic variability and exposure-response relationships of Venetoclax (VEN) in adult patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. The study was conducted ina real-world clinical setting and included 48 patients who were treated with VEN in combination with azacytidine. We found significant inter-individual variability of 68% and intra-individual variability of 39% in plasma VEN concentrations. In addition, higher VEN concentrations were associated with better hematological responses. Median overall survival for the entire cohort was 17.8 months, with 1-and 2-year survival rates of 51% and 36.4%, respectively. A comparison of the 14-day VEN and 28-day VEN protocols showed that patients benefited from longer treatment durations, which resulted in more courses being administered. Plasma concentrations in the 14-day VEN protocol were higher than in the 28-day VEN protocol (2330 + 1675 ng/mL vs. 1503 + 966 ng/mL, respectively) without an increase in toxicities. The optimal protocol would be 400 mg/14d if we consider survival as a function of the 1818ng/mL cutoff. These results highlight the importance of considering therapeutic drug monitoring (TDM) as a strategy to optimize treatment outcomes by balancing efficacy and safety.  \nKeywords Pharmacokinetic variability · Venetoclax · Acute myeloid leukemia · Therapeutic drug monitoring · Hematological toxicity  \nGeoffroy Venton and Raphaëlle Fanciullino contributed equally to this work.  \n􀀍 Laurent Bourguignon [laurent.bourguignon@chu-lyon.fr](laurent.bourguignon@chu-lyon.fr)  \nRaphaëlle Fanciullino  \n[raphaelle.fanciullino@ap-hm.fr](raphaelle.fanciullino@ap-hm.fr)  \n1 Pharmacie hôpital la Conception, APHM, Marseille, France  \n2 COMPO UMR Inserm 1068, CNRS UMR 7258, Aix Marseille Université, Marseille, France  \n3 Service de Pharmacie, Hospices Civils de Lyon, Groupement Hospitalier Nord, Lyon, France  \n4 Laboratoire de Biométrie et Biologie Évolutive, Univ Lyon, Université Claude Bernard Lyon 1, UMR CNRS 5558, Villeurbanne, France  \n5 Service d ’Hématologie et Thérapie Cellulaire, Centre Hospitalo-Universitaire de la Conception. Assistance Publique des Hôpitaux de Marseille, Marseille, France  \n6 Etablissement Français du Sang PACA Corse, Marseille, France  \n7 Laboratoire PRISM, Aix Marseille université, Marseille, France  \n8 Aix Marseille Université CNRS EFSADES UMR7268, Marseille, France  \n9 Laboratoire de Pharmacocinétique et Toxicologie, APHM, Hôpital La Timone, Unité des Virus Émergents (UVE: AixMarseille Univ-IRD 190-Inserm 1207), Marseille, France  \n10 Integrative molecular biology in hematopoiesis and leukemia, Equipe Labellisée Ligue Contre le Cancer, CRCM, Inserm UMR1068, CNRS UMR7258, Institut PaoliCalmettes, Aix Marseille Univ, , Marseille, France  \n11 Hospitalisation à Domicile, APHM, Hôpital de la Conception, Marseille, France  \n12 Département d’hématologie, Université Cote, D’azur, CHU de Nice, Nice, France  \nIntroduction  \nAcute myeloid leukemia (AML) is the most common typeof acute leukemia [1] . Survival rates are particularly poor in older patients aged 65–70 years. In addition, elderly people with frequent comorbidities account for 50% of AML patients [2, 3] . For years, the canonical treatment for AMLin the elderly has b","cbCaiq1gO9Y8AVep","https://ap.wps.com/l/cbCaiq1gO9Y8AVep","pdf",1266241,11,"English","# Abstract\n# Introduction\n## Real-world use of VEN+azacytidine in AML\n## Variability and dosing adjustments in exposure duration","[{\"question\":\"Who were included in the study and what treatment did they receive?\",\"answer\":\"The study enrolled 48 adult AML patients ineligible for intensive chemotherapy. All patients received Venetoclax (VEN) in combination with azacytididine in a real-world clinical setting.\"},{\"question\":\"How did VEN plasma exposure relate to treatment response and survival?\",\"answer\":\"Higher VEN plasma concentrations were associated with better hematological responses. The median overall survival was 17.8 months, with 1-year and 2-year survival rates of 51% and 36.4%, respectively.\"},{\"question\":\"What was the difference between the 14-day and 28-day VEN protocols?\",\"answer\":\"Patients benefited from longer treatment durations, resulting in more courses administered. Plasma concentrations in the 14-day protocol were higher than in the 28-day protocol without an increase in toxicities.\"}]","Predicting the toxicity-efficacy ratio of venetoclax in real-world patients | PDF",1790652115,28]