We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Gilteritinib versus chemotherapy in Japanese patients with FLT3-mutated relapsed/refractory acute myeloid leukemia.
- 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
- 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.
- Subjects
JAPAN; ACUTE myeloid leukemia; JAPANESE people; OVERALL survival; FEBRILE neutropenia; PLATELET count
- Publication
International Journal of Clinical Oncology, 2021, Vol 26, Issue 11, p2131
- ISSN
1341-9625
- Publication type
Article
- DOI
10.1007/s10147-021-02006-7