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Ann Hematol. 2019 Sep 11. doi: 10.1007/s00277-019-03795-8. [Epub ahead of print]

Midostaurin in combination with intensive chemotherapy is safe and associated with improved remission rates and higher transplantation rates in first remission-a multi-center historical control study.

Author information

1
Institute of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.
2
Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
3
Bone Marrow Transplantation Unit, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
4
Department of Hematology and Bone Marrow Transplantation, Rambam Health Care Campus, Haifa, Israel.
5
The Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.
6
Department of Hematology, Meir Medical Center, Kfar Saba, Israel.
7
Department of Hematology, Shamir Medical Center, Zeriffin, Israel.
8
Hematological Laboratories, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel.
9
Institute of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel. owolach@gmail.com.
10
Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. owolach@gmail.com.

Abstract

The addition of midostaurin, a FLT3-inhibitor, to intensive chemotherapy (IC) was previously shown to improve outcome of younger patients with FLT3-mutated AML. The toxicity and efficacy of adding midostaurin to IC in patients not originally included in the RATIFY study or with intensified daunorubicin dosing are unknown. We conducted a retrospective, multi-center, historical-control study to characterize the safety and efficacy of adding midostaurin to IC in a "real-world" setting. Sixty-nine adult patients were included in the analysis (midostaurin n = 34, historical controls n = 35) with a mean follow-up of 18.4 (± 15) months. Median age of patients was 60 (range 26-82) years; 32% and 20% of patients were > 65 and 70 years, respectively. No differences in baseline characteristics were noted between the groups. Midostaurin was administered with 90 mg/m2 daunorubicin in 29% of patients; One-third of patients experienced dose reductions/interruptions during midostaurin therapy. Overall toxicity was comparable between the midostaurin and control groups.CR/CRi rates were higher in patients treated with midostaurin compared with controls (80% vs. 57%, p = 0.047) and significantly more patients in the midostaurin group were transplanted in first remission (95% vs. 68%, p = 0.04).Median OS and DFS were higher in the midostaurin vs. control group (not reached vs. 11 months (p = 0.085) and 13 vs. 6 months (p = 0.09), respectively). In our analysis, midostaurin was not associated with increased toxicity including in older patients, in those with secondary AML or when administered with intensified daunorubicin dosage. Higher remission rates in the midostaurin group and increased transplantation rates in first CR were associated with a trend towards better outcomes.

KEYWORDS:

Acute myeloid leukemia; FLT3 mutation; Midostaurin

PMID:
31512015
DOI:
10.1007/s00277-019-03795-8

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