Ratifying the efficacy and safety of intensive induction chemotherapy for acute myeloid leukaemia by the Australasian Leukaemia & Lymphoma Group consensus approach.
Aditya Tedjaseputra, Amanda Tey, Anastasios Nalpantidis, George Grigoriadis, Shaun Fleming, Shahla Vilcassim, Pasquale L Fedele, Michael Sze Yuan Low, Paul Yeh, Michael Gilbertson, Ashwini Bennett, Gareth P Gregory, Danielle Oh, Donna Gairns, Zane Kaplan, Sanjeev D Chunilal, Susan Brown, Stephen Opat, Chong C Chua, Jake Shortt
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引用次数: 0
Abstract
Background: After pharmaceutical benefits scheme approval of midostaurin for fms-like tyrosine kinase 3 (FLT3)-mutated acute myeloid leukaemia (AML) in 2018, the Australasian Leukaemia & Lymphoma Group (ALLG) proposed a consensus approach to AML induction with 7+3 chemotherapy (7 days of infusional cytarabine with three doses of anthracycline) to align with future clinical trial protocols.
Aims: To determine the efficacy and safety of idarubicin-based 7+3 induction ± midostaurin (per ALLG recommendations) in a real-world, tertiary hospital setting.
Methods: Data were prospectively collected for all patients assessed for front-line AML treatment. Disease risk and response assessments were defined by European LeukaemiaNet 2017 guidelines. Efficacy and safety endpoints included complete remission (CR) rates, composite CR rates, event-free survival (EFS), overall survival (OS), induction mortality, duration of cytopenias and intensive care unit (ICU) utilisation. Analysis was planned following completion of ≥50 inductions and 5-year aggregated experience.
Results: Between 2018 and 2023, 58 patients (median age 49 years) received 7+3 induction with CR and induction mortality rates of 88% (95% confidence interval (95% CI): 77-95%) and 1.7% (95% CI: 0-9%) respectively. At a median of 24.6 months of follow-up, median OS was 17.6 months for adverse-risk versus not reached for non-adverse-risk patients (P = 0.03). FLT3-mutated patients demonstrated an 89% CR rate (95% CI: 67%-99%) with comparable 4-year EFS (65%) and OS (68%) to FLT3-wild-type patients. Safety across 58 induction and 139 consolidation cycles was acceptable, with a single death and a 21% ICU admission rate (95% CI: 11%-33%) during induction.
Conclusions: Idarubicin-based 7+3 induction with contemporary supportive care yields good safety and CR rates, including in midostaurin-treated FLT3-mutated patients. Survival outcomes for adverse-risk AML patients remain suboptimal.
期刊介绍：
The Internal Medicine Journal is the official journal of the Adult Medicine Division of The Royal Australasian College of Physicians (RACP). Its purpose is to publish high-quality internationally competitive peer-reviewed original medical research, both laboratory and clinical, relating to the study and research of human disease. Papers will be considered from all areas of medical practice and science. The Journal also has a major role in continuing medical education and publishes review articles relevant to physician education.
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