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Gilteritinib versus salvage chemotherapy in predominantly Asian patients with relapsed/refractory FLT3-mutated acute myeloid leukemia: a regional analysis of COMMODORE in China, South-East Asia, and Russia

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机构: [1]Peking Univ Int Hosp, Dept Hematol, Beijing, Peoples R China [2]Peking Union Med Coll Hosp, Dept Hematol, Beijing, Peoples R China [3]Shanghai Jiao Tong Univ, Sch Med, Tongren Hosp, Dept Hematol, Shanghai, Peoples R China [4]Guangdong Prov Peoples Hosp, Dept Hematol, Guangzhou, Guangdong, Peoples R China [5]Peking Univ, Peoples Hosp, Dept Hematol, Beijing, Peoples R China [6]Fujian Med Univ, Union Hosp, Fujian Inst Hematol, Fuzhou 350001, Fujian, Peoples R China [7]Fujian Med Univ, Affiliated Hosp 2, Quanzhou, Peoples R China [8]Astellas China Investment Co Ltd, Beijing, Peoples R China [9]Astellas Pharma Inc, Tokyo, Japan [10]Almazov Natl Med Res Ctr, Personalized Med Ctr, St Petersburg, Russia [11]Pavlov Univ, RM Gorbacheva Res Inst, Dept Bone Marrow Transplantat Children 2, St Petersburg, Russia [12]Queen Elizabeth Hosp, Dept Hematol, Kota Kinabalu, Sabah, Malaysia [13]Mahidol Univ, Fac Med, Div Hematol, Dept Med,Siriraj Hosp, Bangkok, Thailand [14]Krasnoyarsk Reg Clin Hosp, Dept Hematol & Chemotherapy, Krasnoyarsk, Russia [15]Astellas Pharma Inc, Northbrook, IL USA [16]Chinese Acad Med Sci & Peking Union Med Coll, State Key Lab Expt Hematol, Natl Clin Res Ctr Blood Dis, Inst Hematol & Blood Dis Hosp, Tianjin, Peoples R China
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The COMMODORE study demonstrated the efficacy and safety of gilteritinib versus salvage chemotherapy (SC) treatment in a predominantly Asian population with relapsed/refractory (R/R) FMS-like tyrosine kinase 3 (FLT3)-mutated((mut+)) acute myeloid leukemia (AML); here we present an exploratory analysis of the study stratified by region (China, South-East Asia and Russia). COMMODORE was a Phase 3, open-label, randomized (1:1), multicenter trial. There were 151, 50, and 33 patients in the China, South-East Asia, and Russia cohorts, respectively. Patients treated with gilteritinib had prolonged median overall survival (OS) versus SC-treated patients in all regions (China: 10.0 vs. 5.7 months, HR [95% CI]: 0.614 [0.385, 0.981]; South-East Asia: 7.8 vs. 4.7 months, HR [95% CI]: 0.887 [0.427, 1.843]; Russia: 8.8 vs. 2.6 months, HR [95% CI]: 0.271 [0.111, 0.662]). Improvements in event-free survival (EFS) were observed in the gilteritinib versus SC arms across all cohorts (China: 2.1 vs. 0.8 months; HR [95% CI]: 0.645 [0.427, 0.974]; South-East Asia 2.4 vs. < 0.1 months; HR [95% CI]: 0.415 [0.208, 0.830]; Russia: 6.2 vs. 0.6 months; HR [95% CI]: 0.221 [0.080, 0.614]). Complete remission rates were numerically higher in the gilteritinib versus SC arm across all three regions. Gilteritinib compared with SC treatment improved OS and EFS with no new safety signals, reinforcing the known efficacy and safety profile of gilteritinib in patients with R/R FLT3(mut+) AML, and affirming the clinical benefit of gilteritinib in three different patient populations. ClinicalTrials.gov identifier: NCT03182244.

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大类 | 3 区 医学
小类 | 3 区 血液学
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大类 | 3 区 医学
小类 | 3 区 血液学
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出版当年[2023]版:
Q2 HEMATOLOGY
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Q2 HEMATOLOGY

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第一作者机构: [1]Peking Univ Int Hosp, Dept Hematol, Beijing, Peoples R China
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