TY - JOUR
T1 - Gilteritinib versus chemotherapy in Japanese patients with FLT3-mutated relapsed/refractory acute myeloid leukemia
AU - Hosono, Naoko
AU - Yokoyama, Hisayuki
AU - Aotsuka, Nobuyuki
AU - Ando, Kiyoshi
AU - Iida, Hiroatsu
AU - Ishikawa, Takayuki
AU - Usuki, Kensuke
AU - Onozawa, Masahiro
AU - Kizaki, Masahiro
AU - Kubo, Kohmei
AU - Kuroda, Junya
AU - Kobayashi, Yukio
AU - Shimizu, Takayuki
AU - Chiba, Shigeru
AU - Nara, Miho
AU - Hata, Tomoko
AU - Hidaka, Michihiro
AU - Fujiwara, Shin Ichiro
AU - Maeda, Yoshinobu
AU - Morita, Yasuyoshi
AU - Kusano, Mikiko
AU - Lu, Qiaoyang
AU - Miyawaki, Shuichi
AU - Berrak, Erhan
AU - Hasabou, Nahla
AU - Naoe, Tomoki
N1 - Funding Information:
SF has received personal fees from Astellas Pharma, Celgene, Chugai Pharmaceutical, Eisai, Kyowa Hakko Kirin, Nippon Shinyaku, Novartis, Ortho Clinical Diagnostics, Otsuka, and Pfizer, all outside the submitted work. SC has received financial support from Astellas Pharma, Ono Pharmaceutical Co, Kyowa-Kirin, Takeda Pharmaceuticals, Sanofi, Bristol-Myers Squibb, and Chugai Pharmaceutical. M Kizaki has received personal fees from Bristol-Myers Squibb, Celgene, Novartis Pharma, Janssen Pharma, and Sumitomo Dainippon Pharma, all outside the submitted work. M Kizaki also received grants and personal fees from Takeda, Kyowa Kirin, and Ono Pharmaceutical, as well as grants from Chugai Pharmaceutical and Daiichi-Sankyo, all outside the submitted work. TN has received personal fees from Eisai, Astellas Pharma, Nippon Shinyaku, Bristol-Myers Squibb, and Sysmex, all outside the submitted work. Y Maeda has received honoraria from Mundipharma, Kyowa-Kirin, Bristol-Myers Squibb, Chugai Pharma, Pfizer, Celgene, Novartis, and Pfizer. Y Maeda also received research funding from Astellas Pharma, Bristol-Myers Squibb, Takeda, Kyowa Kirin, and Chugai Pharmaceutical. TS has received grants from Astellas Pharma during the conduct of the study. TS also received personal fees from Eisai, Novartis, Kyowa Kirin, Takeda Pharmaceutical, Celgene, Bristol-Myers Squibb, Ono Pharmaceutical, Pfizer, Janssen Pharmaceutical, and Otsuka Pharmaceutical, all outside the submitted work. KU has received grants and personal fees from Astellas Pharma, Alexion Pharmaceuticals, AbbVie, Gilead, SymBio Pharmaceuticals, Daiichi Sankyo, Otsuka Pharmaceutical, Novartis, Bristol-Myers Squibb, Ono Pharmaceutical, Celgene, Takeda Pharmaceutical, Nippon, Boehringer Ingelheim, and Kyowa Kirin. KU also received grants from Sumitomo Dainippon Pharma, Chugai Pharmaceutical, Janssen Pharmaceutical, Mundipharma, Astellas-Amgen-Biopharma, Apellis Pharmaceuticals, Nippon Shinyaku, and Pfizer. KU also received personal fees from Eisai, MSD, SymBio Pharmaceuticals, PharmaEssentia Corp., and Yakult Honsha, all outside the submitted work. YK received grants, personal fees, and other support from Pfizer; YK also received personal fees from Astellas and Symbio, all outside the submitted work. JK has received other support from Astellas during the conduct of the study; JK has also received grants and personal fees from Astellas outside the submitted work. M Kusano, QL, EB, and N Hasabou are all employees of Astellas Pharma. N Hosono, HY, NA, KA, KK, TH, MH, MN, TI, MO, and Y Morita have no financial relationships to disclose.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/11
Y1 - 2021/11
N2 - 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 < 0.001). 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. Results: Median 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%). Conclusion: Findings in Japanese patients are consistent with those of the overall ADMIRAL study population.
AB - 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 < 0.001). 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. Results: Median 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%). Conclusion: Findings in Japanese patients are consistent with those of the overall ADMIRAL study population.
KW - Acute myeloid leukemia
KW - FLT3 inhibitor
KW - FLT3 mutations
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U2 - 10.1007/s10147-021-02006-7
DO - 10.1007/s10147-021-02006-7
M3 - Article
C2 - 34363558
AN - SCOPUS:85112031252
SN - 1341-9625
VL - 26
SP - 2131
EP - 2141
JO - International Journal of Clinical Oncology
JF - International Journal of Clinical Oncology
IS - 11
ER -