title: Outcomes with frontline nilotinib treatment in Turkish patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.
abstract: 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.
  
  
  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.
authors: a Department of Internal Medicine , Ege University Medical Faculty Hospital , Izmir , Turkey.
authors: Guray
authors: G
authors: Saydam
authors: b Department of Internal Medicine , Hacettepe University Medical Faculty Hospital , Ankara , Turkey.
authors: Ibrahim Celalettin
authors: IC
authors: Haznedaroglu
authors: c Hematology Division , Erciyes University Medical Faculty Hospital , Kayseri , Turkey.
authors: Leylagul
authors: L
authors: Kaynar
authors: d Department of Internal Medicine , Istanbul University Istanbul Medical Faculty , Istanbul , Turkey.
authors: Akif S
authors: AS
authors: Yavuz
authors: e Department of Internal Medicine , Uludag University Medical Faculty , Bursa , Turkey.
authors: Ridvan
authors: R
authors: Ali
authors: f Department of Internal Medicine , Cukurova University Medical Faculty Hospital , Adana , Turkey.
authors: Birol
authors: B
authors: Guvenc
authors: g Department of Internal Medicine , Eskisehir Osmangazi University Medical Faculty Hospital , Eskisehir , Turkey.
authors: Olga M
authors: OM
authors: Akay
authors: h Istanbul University Cerrahpasa Medical Faculty , Istanbul , Turkey.
authors: Zafer
authors: Z
authors: Baslar
authors: i Institute of Experimental Medicine (DETAE) , Istanbul University , Istanbul , Turkey.
authors: Ugur
authors: U
authors: Ozbek
authors: j Department of Internal Medicine , Karadeniz Technical University Medical Faculty , Trabzon , Turkey.
authors: Mehmet
authors: M
authors: Sonmez
authors: k Okmeydani Training and Research Hospital , Istanbul , Turkey.
authors: Demet
authors: D
authors: Aydin
authors: l Department of Internal Medicine , Gaziantep University Medical Faculty , Gaziantep , Turkey.
authors: Mustafa
authors: M
authors: Pehlivan
authors: m Department of Internal Medicine , Dokuz Eylul University Medical Faculty , Izmir , Turkey.
authors: Bulent
authors: B
authors: Undar
authors: n Department of Internal Medicine , Ankara Numune Training and Research Hospital , Ankara , Turkey.
authors: Simten
authors: S
authors: Dagdas
authors: o Medical Faculty Hospital, Department of Internal Medicine , Dicle University , Diyarbakir , Turkey.
authors: Orhan
authors: O
authors: Ayyildiz
authors: p Novartis Pharmaceuticals Corporation , Istanbul , Turkey.
authors: Diyar Z
authors: DZ
authors: Akkaynak
authors: p Novartis Pharmaceuticals Corporation , Istanbul , Turkey.
authors: Ilkiz M
authors: IM
authors: Dag
authors: q Ankara University School of Medicine , Ankara , Turkey.
authors: Osman
authors: O
authors: Ilhan
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D005260:Female; D016044:Fusion Proteins, bcr-abl / Q000037:antagonists & inhibitors; D006801:Humans; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*; D011743:Pyrimidines / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; D016044:Fusion Proteins, bcr-abl; C498826:nilotinib
keywords: BCR-ABL1; chronic myeloid leukemia; molecular response; nilotinib; tyrosine kinase inhibitor