PMID- 32812818
OWN - NLM
STAT- MEDLINE
DCOM- 20210427
LR  - 20210427
IS  - 1029-2403 (Electronic)
IS  - 1026-8022 (Linking)
VI  - 61
IP  - 13
DP  - 2020 Dec
TI  - Updated safety of midostaurin plus chemotherapy in newly diagnosed FLT3 
      mutation-positive acute myeloid leukemia: the RADIUS-X expanded access program.
PG  - 3146-3153
LID - 10.1080/10428194.2020.1805109 [doi]
AB  - Approval of midostaurin, a multikinase inhibitor, in combination with 
      chemotherapy for the treatment of adults with newly diagnosed FLT3 
      mutation-positive acute myeloid leukemia, was based on the phase 3 RATIFY trial 
      results. RADIUS-X (NCT02624570) was an expanded access program providing access 
      to midostaurin during regulatory review and extending the understanding of the 
      safety and tolerability of midostaurin. Patients aged >/=18 years received 
      midostaurin with 1-2 cycles of induction therapy (cytarabine plus daunorubicin or 
      idarubicin) and </=4 cycles of high-dose cytarabine consolidation chemotherapy or 
      as single-agent maintenance therapy. The study enrolled 103 patients. No new 
      safety events were observed; toxicities were not influenced by age, anthracycline 
      choice, or coadministration of CYP3A4 inhibitors. The most common adverse events 
      (AEs) were febrile neutropenia, nausea, and diarrhea. During maintenance, 46% of 
      patients reported AEs. Midostaurin demonstrated a manageable safety profile and 
      was associated with high transplant and low on-treatment relapse rates.
FAU - Roboz, Gail J
AU  - Roboz GJ
AD  - Weill Cornell Medicine, New York-Presbyterian Hospital, New York, NY, USA.
FAU - Strickland, Stephen A
AU  - Strickland SA
AUID- ORCID: 0000-0002-6861-2041
AD  - Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.
FAU - Litzow, Mark R
AU  - Litzow MR
AUID- ORCID: 0000-0002-9816-6302
AD  - Mayo Clinic, Rochester, MN, USA.
FAU - Dalovisio, Andrew
AU  - Dalovisio A
AD  - Ochsner Medical Center, New Orleans, LA, USA.
FAU - Perl, Alexander E
AU  - Perl AE
AUID- ORCID: 0000-0002-1463-2231
AD  - University of Pennsylvania, Philadelphia, PA, USA.
FAU - Bonifacio, Gaetano
AU  - Bonifacio G
AD  - Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
FAU - Haines, Kelly
AU  - Haines K
AD  - Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
FAU - Barbera, Alysha
AU  - Barbera A
AD  - Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
FAU - Purkayastha, Das
AU  - Purkayastha D
AD  - Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
FAU - Sweet, Kendra
AU  - Sweet K
AD  - Moffitt Cancer Center, Tampa, FL, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02624570
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200819
PL  - United States
TA  - Leuk Lymphoma
JT  - Leukemia & lymphoma
JID - 9007422
RN  - 0 (Protein Kinase Inhibitors)
RN  - EC 2.7.10.1 (FLT3 protein, human)
RN  - EC 2.7.10.1 (fms-Like Tyrosine Kinase 3)
RN  - H88EPA0A3N (Staurosporine)
RN  - ID912S5VON (midostaurin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Humans
MH  - *Leukemia, Myeloid, Acute/diagnosis/drug therapy/genetics
MH  - Mutation
MH  - Protein Kinase Inhibitors/adverse effects
MH  - *Radius
MH  - Staurosporine/analogs & derivatives
MH  - fms-Like Tyrosine Kinase 3/genetics
OTO - NOTNLM
OT  - Acute myeloid leukemia
OT  - FLT3
OT  - idarubicin
OT  - maintenance
OT  - midostaurin
EDAT- 2020/08/20 06:00
MHDA- 2021/04/28 06:00
CRDT- 2020/08/20 06:00
PHST- 2020/08/20 06:00 [pubmed]
PHST- 2021/04/28 06:00 [medline]
PHST- 2020/08/20 06:00 [entrez]
AID - 10.1080/10428194.2020.1805109 [doi]
PST - ppublish
SO  - Leuk Lymphoma. 2020 Dec;61(13):3146-3153. doi: 10.1080/10428194.2020.1805109. 
      Epub 2020 Aug 19.