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

Naoko Hosono, Hisayuki Yokoyama, Nobuyuki Aotsuka, Kiyoshi Ando, Hiroatsu Iida, Takayuki Ishikawa, Kensuke Usuki, Masahiro Onozawa, Masahiro Kizaki, Kohmei Kubo, Junya Kuroda, Yukio Kobayashi, Takayuki Shimizu, Shigeru Chiba, Miho Nara, Tomoko Hata, Michihiro Hidaka, Shin Ichiro Fujiwara, Yoshinobu Maeda, Yasuyoshi MoritaMikiko Kusano, Qiaoyang Lu, Shuichi Miyawaki, Erhan Berrak, Nahla Hasabou, Tomoki Naoe

Research output: Contribution to journalArticlepeer-review

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 < 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.

Original languageEnglish
Pages (from-to)2131-2141
Number of pages11
JournalInternational Journal of Clinical Oncology
Volume26
Issue number11
DOIs
Publication statusPublished - Nov 2021
Externally publishedYes

Keywords

  • Acute myeloid leukemia
  • FLT3 inhibitor
  • FLT3 mutations

ASJC Scopus subject areas

  • Surgery
  • Hematology
  • Oncology

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