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Clinical Outcomes and Characteristics of Patients (pts) with FLT3–Internal Tandem Duplication (FLT3-ITD)–Mutated Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) Undergoing Hematopoietic Stem Cell Transplant (HSCT) after Quizartinib (Q) or Salvage Chemotherapy (SC) in the Quantum-R Trial

S. Ganguly, J. Cortes, A. Krämer, M. Levis, G. Martinelli, A. Perl, N. Russell, M. Arunachalam et al.

Biology of Blood and Marrow Transplantation, 2020

4 citations

Abstract

Introduction In QuANTUM-R, the once-daily, oral, highly potent and selective FLT3 inhibitor Q improved clinical benefit vs SC (median overall survival [mOS], 6.2 vs 4.7 mo [HR, 0.76 (95% CI, 0.58-0.98); P = .02]) in R/R FLT3-ITD AML (NCT02039726). Before randomization, 25% (Q) and 23% (SC) of pts had 1 prior HSCT. Objective To describe post hoc analyses in pts who underwent subsequent HSCT during QuANTUM-R. Methods Pts with FLT3-ITD R/R AML received Q (60 mg [30-mg lead-in]) or SC. Pts in the Q arm could resume Q 30-100 d after HSCT. Decisions to proceed to HSCT and resume Q after HSCT were made per investigator discretion/institutional policy. Results Of 367 randomized pts, 85 in the Q arm underwent any subsequent HSCT (allogeneic HSCT [allo-HSCT], 84 [6 with and 78 w/o additional AML therapy]; autologous HSCT, 1), and 19 in the SC arm underwent any HSCT (5 with and 14 w/o additional AML therapy]). Q + SC pooled data showed a longer mOS (95% CI) in 104 pts with any HSCT vs 263 w/o (12.2 [10.0-24.1] vs 4.4 [4.1-4.9] mo; P Regardless of treatment, mOS was longer with any HSCT vs w/o (Q, 11.9 [10.2-25.1] vs 4.5 [4.1-5.4] mo; SC, 12.7 [6.1-NA] vs 4.0 [2.7-5.0] mo); respective 1-year OS rates were 50% vs 13% and 51% vs 12%. In the Q arm, mOS (95% CI) was longer in pts with a best response of CRc who resumed Q after allo-HSCT (27.1 [18.2-NA] mo) vs pts not resuming Q (5.4 [4.7-11.4] mo; Fig 2). In 48 pts (62%) in the Q arm resuming Q after allo-HSCT, median time from allo-HSCT to…

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