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Gilteritinib versus chemotherapy in Japanese patients with FLT3-mutated relapsed/refractory acute myeloid leukemia |
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| Authors: | Hosono Naoko Yokoyama Hisayuki Aotsuka Nobuyuki Ando Kiyoshi Iida Hiroatsu Ishikawa Takayuki Usuki Kensuke Onozawa Masahiro Kizaki Masahiro Kubo Kohmei Kuroda Junya Kobayashi Yukio Shimizu Takayuki Chiba Shigeru Nara Miho Hata Tomoko Hidaka Michihiro Fujiwara Shin-Ichiro Maeda Yoshinobu Morita Yasuyoshi Kusano Mikiko Lu Qiaoyang Miyawaki Shuichi Berrak Erhan Hasabou Nahla Naoe Tomoki |
| Affiliation: | 1.Department of Hematology and Oncology, Faculty of Medical Sciences, University of Fukui, Fukui, 910-1193, Japan ;2.Sendai Medical Center, Sendai, Japan ;3.Japanese Red Cross Narita Hospital, Narita, Japan ;4.Tokai University School of Medicine, Isehara, Japan ;5.NHO Nagoya Medical Center, Nagoya, Japan ;6.Kobe City Medical Center General Hospital, Hyogo, Japan ;7.NTT Medical Center Tokyo, Tokyo, Japan ;8.Hokkaido University, Sapporo, Japan ;9.Saitama Medical Center, Saitama Medical University, Kawagoe, Japan ;10.Aomori Prefectural Central Hospital, Aomori, Japan ;11.Kyoto Prefectural University of Medicine, Kyoto, Japan ;12.International University of Health and Welfare (IUHW), Mita Hospital, Tokyo, Japan ;13.Keio University School of Medicine, Tokyo, Japan ;14.University of Tsukuba, Tsukuba, Japan ;15.Akita University, Akita, Japan ;16.Nagasaki University, Nagasaki, Japan ;17.Kumamoto Medical Center, Kumamoto, Japan ;18.Jichi Medical University, Shimotsuke, Japan ;19.Okayama University Hospital, Okayama, Japan ;20.Kindai University, Osaka, Japan ;21.Astellas Pharma, Inc., Tokyo, Japan ;22.Astellas Pharma US, Inc., Northbrook, IL, USA ;23.Tokyo Metropolitan Ohtsuka Hospital, Tokyo, Japan ; |
| Abstract: | Background Until recently, no effective targeted therapies for FLT3-mutated (FLT3mut+) relapsed/refractory (R/R) acute myeloid leukemia (AML) were available in Japan. The FLT3 inhibitor, gilteritinib, was approved in Japan for patients with FLT3mut+ R/R AML based on the phase 3 ADMIRAL trial, which demonstrated the superiority of gilteritinib over salvage chemotherapy (SC) with respect to overall survival (OS; median OS, 9.3 vs 5.6 months, respectively; hazard ratio, 0.64 [95% confidence interval 0.49, 0.83]; P?Methods We evaluated the Japanese subgroup (n?=?48) of the ADMIRAL trial, which included 33 patients randomized to 120-mg/day gilteritinib and 15 randomized to SC. ResultsMedian OS was 14.3 months in the gilteritinib arm and 9.6 months in the SC arm. The complete remission/complete remission with partial hematologic recovery rate was higher in the gilteritinib arm (48.5%) than in the SC arm (13.3%). After adjustment for drug exposure, fewer adverse events (AEs) occurred in the gilteritinib arm than in the SC arm. Common grade?≥?3 AEs related to gilteritinib were febrile neutropenia (36%), decreased platelet count (27%), and anemia (24%). ConclusionFindings in Japanese patients are consistent with those of the overall ADMIRAL study population. |
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