PMID- 29486663
OWN - NLM
STAT- Publisher
LR  - 20240227
IS  - 1607-8454 (Electronic)
IS  - 1024-5332 (Linking)
DP  - 2018 Feb 27
TI  - Outcomes with frontline nilotinib treatment in Turkish patients with newly 
      diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic 
      phase.
PG  - 1-7
LID - 10.1080/10245332.2018.1444919 [doi]
AB  - OBJECTIVES: 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. This 
      study is registered with ClinicalTrials.gov (NCT01274351). RESULTS: 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, one patient progressed to blast crisis and two 
      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. 
      CONCLUSION: 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 with 
      low and intermediate risk.
FAU - Saydam, Guray
AU  - Saydam G
AD  - a Department of Internal Medicine , Ege University Medical Faculty Hospital , 
      Izmir , Turkey.
FAU - Haznedaroglu, Ibrahim C
AU  - Haznedaroglu IC
AD  - b Department of Internal Medicine , Hacettepe University Medical Faculty Hospital 
      , Ankara , Turkey.
FAU - Kaynar, Leylagul
AU  - Kaynar L
AUID- ORCID: 0000-0002-2035-9462
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 Cerrahpasa Medical Faculty , Istanbul University , 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 Hematology Department , 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 Department of Internal Medicine , Dicle University Medical Faculty Hospital , 
      Diyarbakir , Turkey.
FAU - Akkaynak, Diyar Z
AU  - Akkaynak DZ
AD  - p Novartis Pharmaceuticals Corporation , Istanbul , Turkey.
FAU - Akin, Gulnur
AU  - Akin G
AD  - p Novartis Pharmaceuticals Corporation , Istanbul , Turkey.
FAU - Ilhan, Osman
AU  - Ilhan O
AD  - q Ankara University School of Medicine , Ankara , Turkey.
LA  - eng
SI  - ClinicalTrials.gov/NCT01274351
PT  - Journal Article
PT  - Retracted Publication
DEP - 20180227
PL  - England
TA  - Hematology
JT  - Hematology (Amsterdam, Netherlands)
JID - 9708388
RIN - Hematology. 2018 Oct;23(9):720. PMID: 29578377
OTO - NOTNLM
OT  - BCR-ABL1
OT  - chronic myeloid leukemia
OT  - molecular response
OT  - nilotinib
OT  - tyrosine kinase inhibitor
EDAT- 2018/03/01 06:00
MHDA- 2018/03/01 06:00
CRDT- 2018/03/01 06:00
PHST- 2018/03/01 06:00 [entrez]
PHST- 2018/03/01 06:00 [pubmed]
PHST- 2018/03/01 06:00 [medline]
AID - 10.1080/10245332.2018.1444919 [doi]
PST - aheadofprint
SO  - Hematology. 2018 Feb 27:1-7. doi: 10.1080/10245332.2018.1444919.