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Sorafenib Combined with 5‐azacytidine in Older Patients with Untreated FLT3 ‐ITD Mutated Acute Myeloid Leukemia
Author(s) -
Ohanian Maro,
GarciaManero Guillermo,
Levis Mark,
Jabbour Elias,
Daver Naval,
Borthakur Gautam,
Kadia Tapan,
Pierce Sherry,
Burger Jan,
Richie Mary Ann,
Patel Keyur,
Andreeff Michael,
Estrov Zeev,
Cortes Jorge,
Kantarjian Hagop,
Ravandi Farhad
Publication year - 2018
Publication title -
american journal of hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.456
H-Index - 105
eISSN - 1096-8652
pISSN - 0361-8609
DOI - 10.1002/ajh.25198
Subject(s) - medicine , sorafenib , myeloid leukemia , regimen , refractory (planetary science) , chemotherapy regimen , gastroenterology , chemotherapy , azacitidine , oncology , surgery , physics , astrobiology , hepatocellular carcinoma , biochemistry , gene expression , chemistry , dna methylation , gene
Based on our previous study of the combination of sorafenib with 5‐azacytidine (AZA) in relapsed/refractory patients with FLT3 mutated acute myeloid leukemia (AML), we hypothesized that the combination would be efficacious and well tolerated in untreated patients with FLT3 mutated AML who are unsuitable for standard chemotherapy due to advanced age or lack of fitness. Newly diagnosed patients with untreated FLT3 mutated AML who underwent frontline therapy on 2 separate protocols of AZA plus sorafenib were analyzed. The clinical trials were registered at clinicaltrials.gov (NCT02196857 and NCT01254890). Overall, 27 patients with untreated FLT3 mutated AML (median age of 74 years, range, 61‐86) were enrolled. The overall response rate was 78% (7 [26%] CR, 12 [44%] CRi/CRp, and 2 [7%] PR). Patients received a median of 3 treatment cycles (1–35). The median duration of CR/CRp/CRi is 14.5 months (1.1–28.7 months). Three (11%) responding patients (1 CR, 2 CRi) proceeded to allogeneic stem cell transplant. The median follow‐up for surviving patients was 4.1 months (3.0–17.3 months). The median overall survival for the entire group was 8.3 months, and 9.2 months in the 19 responders. The regimen was well tolerated in elderly patients with untreated FLT3 mutated AML with no early deaths.