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Follow-up of patients with R/R FLT3-mutation–positive AML treated with gilteritinib in the phase 3 ADMIRAL trial
DC Field | Value | Language |
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dc.contributor.author | Perl, Alexander E. | - |
dc.contributor.author | Larson, Richard A. | - |
dc.contributor.author | Podoltsev, Nikolai A. | - |
dc.contributor.author | Strickland, Stephen | - |
dc.contributor.author | Wang, Eunice S. | - |
dc.contributor.author | Atallah, Ehab | - |
dc.contributor.author | Schiller, Gary J. | - |
dc.contributor.author | Martinelli, Giovanni | - |
dc.contributor.author | Neubauer, Andreas | - |
dc.contributor.author | Sierra, Jorge | - |
dc.contributor.author | Montesinos, Pau | - |
dc.contributor.author | Récher, Christian | - |
dc.contributor.author | Yoon, Sung-Soo | - |
dc.contributor.author | Hosono, Naoko | - |
dc.contributor.author | Onozawa, Masahiro | - |
dc.contributor.author | Chiba, Shigeru | - |
dc.contributor.author | Kim, Hee-Je | - |
dc.contributor.author | Hasabou, Nahla | - |
dc.contributor.author | Lu, Qiaoyang | - |
dc.contributor.author | Tiu, Ramon | - |
dc.contributor.author | Levis, Mark J. | - |
dc.date.accessioned | 2022-08-22T09:06:48Z | - |
dc.date.available | 2022-08-22T09:06:48Z | - |
dc.date.created | 2022-06-29 | - |
dc.date.issued | 2022-06 | - |
dc.identifier.citation | Blood, Vol.139 No.23, pp.3366-3375 | - |
dc.identifier.issn | 0006-4971 | - |
dc.identifier.uri | https://hdl.handle.net/10371/184310 | - |
dc.description.abstract | © 2022 American Society of HematologyThe phase 3 ADMIRAL (NCT02421939; Study ID: 2215-CL-0301) trial showed superior overall survival in patients with relapsed/refractory FLT3-mutation–positive acute myeloid leukemia (AML) randomized 2:1 to receive the oral FMS-like tyrosine kinase 3 inhibitor gilteritinib vs those randomized to receive salvage chemotherapy (SC). Here we provide a follow-up of the ADMIRAL trial 2 years after the primary analysis to clarify the long-term treatment effects and safety of gilteritinib in these patients with AML. At the time of this analysis, the median survival follow-up was 37.1 months, with deaths in 203 of 247 and 97 of 124 patients in the gilteritinib and SC arms, respectively; 16 gilteritinib-treated patients remained on treatment. The median overall survival for the gilteritinib and SC arms was 9.3 and 5.6 months, respectively (hazard ratio, 0.665; 95% confidence interval [CI], 0.518, 0.853; two-sided P = .0013); 2-year estimated survival rates were 20.6% (95% CI, 15.8, 26.0) and 14.2% (95% CI, 8.3, 21.6). The gilteritinib-arm 2-year cumulative incidence of relapse after composite complete remission was 75.7%, with few relapses occurring after 18 months. Overall, 49 of 247 patients in the gilteritinib arm and 14 of 124 patients in the SC arm were alive for ≥2 years. Twenty-six gilteritinib-treated patients remained alive for ≥2 years without relapse; 18 of these patients underwent transplantation (hematopoietic stem cell transplantation [HSCT]) and 16 restarted gilteritinib as post-HSCT maintenance therapy. The most common adverse events of interest during years 1 and 2 of gilteritinib therapy were increased liver transaminase levels; adverse event incidence decreased in year 2. Thus, continued and post-HSCT gilteritinib maintenance treatment sustained remission with a stable safety profile. These findings confirm that prolonged gilteritinib therapy is safe and is associated with superior survival vs SC. This trial was registered at www.clinicaltrials.gov as #NCT02421939. | - |
dc.language | 영어 | - |
dc.publisher | American Society of Hematology | - |
dc.title | Follow-up of patients with R/R FLT3-mutation–positive AML treated with gilteritinib in the phase 3 ADMIRAL trial | - |
dc.type | Article | - |
dc.identifier.doi | 10.1182/blood.2021011583 | - |
dc.citation.journaltitle | Blood | - |
dc.identifier.wosid | 000813042600007 | - |
dc.identifier.scopusid | 2-s2.0-85129375801 | - |
dc.citation.endpage | 3375 | - |
dc.citation.number | 23 | - |
dc.citation.startpage | 3366 | - |
dc.citation.volume | 139 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Yoon, Sung-Soo | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
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