Gilteritinib versus chemotherapy in Japanese patients with FLT3-mutated relapsed/refractory acute myeloid leukemia

Autor: Mikiko Kusano, Shin ichiro Fujiwara, Takayuki Shimizu, Masahiro Kizaki, Junya Kuroda, Kensuke Usuki, Erhan Berrak, Miho Nara, Shuichi Miyawaki, Tomoki Naoe, Kiyoshi Ando, Yoshinobu Maeda, Nobuyuki Aotsuka, Nahla Hasabou, Yukio Kobayashi, Qiaoyang Lu, Takayuki Ishikawa, Hisayuki Yokoyama, Tomoko Hata, Shigeru Chiba, Naoko Hosono, Masahiro Onozawa, Kohmei Kubo, Michihiro Hidaka, Yasuyoshi Morita, Hiroatsu Iida
Rok vydání: 2021
Předmět:
Zdroj: International Journal of Clinical Oncology
ISSN: 1437-7772
1341-9625
DOI: 10.1007/s10147-021-02006-7
Popis: 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. 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.
Databáze: OpenAIRE
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