Outcomes with frontline nilotinib treatment in Turkish patients with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase. (21st September 2016)

• Record Type: Journal Article
• Authors: Saydam, Guray; Haznedaroglu, Ibrahim Celalettin; Kaynar, Leylagul; Yavuz, Akif S.; Ali, Ridvan; Guvenc, Birol; Akay, Olga M.; Baslar, Zafer; Ozbek, Ugur; Sonmez, Mehmet; Aydin, Demet; Pehlivan, Mustafa; Undar, Bulent; Dagdas, Simten; Ayyildiz, Orhan; Akkaynak, Diyar Z.; Dag, Ilkiz M.; Ilhan, Osman
• Is Part Of: Expert opinion on pharmacotherapy. Volume 17:Number 14(2016)
• Page Start: 1851
• Page End: 1858
• Publication Date: 2016-09-21
• Subjects: BCR-ABL1 -- chronic myeloid leukemia -- molecular response -- nilotinib -- tyrosine kinase inhibitor; Chemotherapy -- Periodicals; 615.5805
• DOI: 10.1080/14656566.2016.1219338
• Languages: English
• ISSNs: 1465-6566

Abstract

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. 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.