PMID- 27501474
OWN - NLM
STAT- MEDLINE
DCOM- 20170310
LR  - 20220114
IS  - 1744-7666 (Electronic)
IS  - 1465-6566 (Linking)
VI  - 17
IP  - 14
DP  - 2016 Oct
TI  - Outcomes with frontline nilotinib treatment in Turkish patients with newly 
      diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic 
      phase.
PG  - 1851-8
LID - 10.1080/14656566.2016.1219338 [doi]
AB  - OBJECTIVE: Nilotinib is a BCR-ABL1 tyrosine kinase inhibitor approved for the 
      treatment of patients with chronic myeloid leukemia in chronic phase (CML-CP). 
      This study was the first prospective evaluation of the efficacy and safety of 
      nilotinib in Turkish patients with newly diagnosed CML-CP. The primary endpoint 
      of the study was the rate of major molecular response (MMR; BCR-ABL1 </= 0.1% on 
      the International Scale [BCR-ABL1(IS)]) by 12 months. METHODS: Patients with 
      newly diagnosed CML-CP were treated with nilotinib 300 mg twice daily. This 
      analysis was based on the first 12 months of follow-up in a 24-month study. 
      RESULTS AND CONCLUSIONS: Of 112 patients enrolled, 66.1% (80% CI, 59.7-72.0%) 
      achieved MMR and 22.3% achieved a deep molecular response of MR(4.5) 
      (BCR-ABL1(IS) </= 0.0032%) by 12 months. During the first year of treatment, 1 
      patient progressed to blast crisis and 2 patients died. Safety results were 
      consistent with previous studies. Most adverse events (AEs) were grade 1/2. Most 
      frequently reported nonhematologic AEs of any grade were elevations in bilirubin, 
      alanine aminotransferase, and triglycerides. These results support the use of 
      nilotinib 300 mg twice daily as a standard-of-care treatment option for patients 
      with newly diagnosed CML-CP.
FAU - Saydam, Guray
AU  - Saydam G
AD  - a Department of Internal Medicine , Ege University Medical Faculty Hospital , 
      Izmir , Turkey.
FAU - Haznedaroglu, Ibrahim Celalettin
AU  - Haznedaroglu IC
AD  - b Department of Internal Medicine , Hacettepe University Medical Faculty Hospital 
      , Ankara , Turkey.
FAU - Kaynar, Leylagul
AU  - Kaynar L
AD  - c Hematology Division , Erciyes University Medical Faculty Hospital , Kayseri , 
      Turkey.
FAU - Yavuz, Akif S
AU  - Yavuz AS
AD  - d Department of Internal Medicine , Istanbul University Istanbul Medical Faculty 
      , Istanbul , Turkey.
FAU - Ali, Ridvan
AU  - Ali R
AD  - e Department of Internal Medicine , Uludag University Medical Faculty , Bursa , 
      Turkey.
FAU - Guvenc, Birol
AU  - Guvenc B
AD  - f Department of Internal Medicine , Cukurova University Medical Faculty Hospital 
      , Adana , Turkey.
FAU - Akay, Olga M
AU  - Akay OM
AD  - g Department of Internal Medicine , Eskisehir Osmangazi University Medical 
      Faculty Hospital , Eskisehir , Turkey.
FAU - Baslar, Zafer
AU  - Baslar Z
AD  - h Istanbul University Cerrahpasa Medical Faculty , Istanbul , Turkey.
FAU - Ozbek, Ugur
AU  - Ozbek U
AD  - i Institute of Experimental Medicine (DETAE) , Istanbul University , Istanbul , 
      Turkey.
FAU - Sonmez, Mehmet
AU  - Sonmez M
AD  - j Department of Internal Medicine , Karadeniz Technical University Medical 
      Faculty , Trabzon , Turkey.
FAU - Aydin, Demet
AU  - Aydin D
AD  - k Okmeydani Training and Research Hospital , Istanbul , Turkey.
FAU - Pehlivan, Mustafa
AU  - Pehlivan M
AD  - l Department of Internal Medicine , Gaziantep University Medical Faculty , 
      Gaziantep , Turkey.
FAU - Undar, Bulent
AU  - Undar B
AD  - m Department of Internal Medicine , Dokuz Eylul University Medical Faculty , 
      Izmir , Turkey.
FAU - Dagdas, Simten
AU  - Dagdas S
AD  - n Department of Internal Medicine , Ankara Numune Training and Research Hospital 
      , Ankara , Turkey.
FAU - Ayyildiz, Orhan
AU  - Ayyildiz O
AD  - o Medical Faculty Hospital, Department of Internal Medicine , Dicle University , 
      Diyarbakir , Turkey.
FAU - Akkaynak, Diyar Z
AU  - Akkaynak DZ
AD  - p Novartis Pharmaceuticals Corporation , Istanbul , Turkey.
FAU - Dag, Ilkiz M
AU  - Dag IM
AD  - p Novartis Pharmaceuticals Corporation , Istanbul , Turkey.
FAU - Ilhan, Osman
AU  - Ilhan O
AD  - q Ankara University School of Medicine , Ankara , Turkey.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
DEP - 20160818
PL  - England
TA  - Expert Opin Pharmacother
JT  - Expert opinion on pharmacotherapy
JID - 100897346
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Protein Kinase Inhibitors)
RN  - 0 (Pyrimidines)
RN  - EC 2.7.10.2 (Fusion Proteins, bcr-abl)
RN  - F41401512X (nilotinib)
SB  - IM
CIN - Expert Opin Pharmacother. 2017 Feb;18(3):327-328. PMID: 28085495
CIN - Expert Opin Pharmacother. 2017 Feb;18(3):325-326. PMID: 28085518
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/*therapeutic use
MH  - Female
MH  - Fusion Proteins, bcr-abl/antagonists & inhibitors
MH  - Humans
MH  - Leukemia, Myelogenous, Chronic, BCR-ABL Positive/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Protein Kinase Inhibitors/*therapeutic use
MH  - Pyrimidines/*therapeutic use
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - BCR-ABL1
OT  - chronic myeloid leukemia
OT  - molecular response
OT  - nilotinib
OT  - tyrosine kinase inhibitor
EDAT- 2016/08/09 06:00
MHDA- 2017/03/11 06:00
CRDT- 2016/08/09 06:00
PHST- 2016/08/09 06:00 [entrez]
PHST- 2016/08/09 06:00 [pubmed]
PHST- 2017/03/11 06:00 [medline]
AID - 10.1080/14656566.2016.1219338 [doi]
PST - ppublish
SO  - Expert Opin Pharmacother. 2016 Oct;17(14):1851-8. doi: 
      10.1080/14656566.2016.1219338. Epub 2016 Aug 18.