Outcomes with frontline nilotinib treatment in Turkish patients with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase
Makaleler > Tam Makale · 2016
Yazarlar: Güray SAYDAM, İBRAHİM CELALETTİN HAZNEDAROĞLU, Leylagül KAYNAR, Akif Yavuz, Ridvan Ali, BİROL GÜVENÇ, Olga M. Akay, Zafer Baslar, Ugur Ozbek, MEHMET SÖNMEZ, Demet AYDIN, Mustafa Pehlivan, Bulent Undar, Simten DAĞDAŞ, Orhan Ayyildiz, Diyar Z. Akkaynak, Ilkiz M. Dag, Osman Ilhan
Expert Opinion on Pharmacotherapy, SCI Expanded İndekslerine Giren Dergi, Uluslararası, Wos, 2016, cilt 17, ss 1851-1858
DOI: 10.1080/14656566.2016.1219338
Özet
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.