Outcomes with frontline nilotinib treatment in Turkish patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

Autor:	Saydam G; a Department of Internal Medicine , Ege University Medical Faculty Hospital , Izmir , Turkey., Haznedaroglu IC; b Department of Internal Medicine , Hacettepe University Medical Faculty Hospital , Ankara , Turkey., Kaynar L; c Hematology Division , Erciyes University Medical Faculty Hospital , Kayseri , Turkey., Yavuz AS; d Department of Internal Medicine , Istanbul University Istanbul Medical Faculty , Istanbul , Turkey., Ali R; e Department of Internal Medicine , Uludag University Medical Faculty , Bursa , Turkey., Guvenc B; f Department of Internal Medicine , Cukurova University Medical Faculty Hospital , Adana , Turkey., Akay OM; g Department of Internal Medicine , Eskisehir Osmangazi University Medical Faculty Hospital , Eskisehir , Turkey., Baslar Z; h Istanbul University Cerrahpasa Medical Faculty , Istanbul , Turkey., Ozbek U; i Institute of Experimental Medicine (DETAE) , Istanbul University , Istanbul , Turkey., Sonmez M; j Department of Internal Medicine , Karadeniz Technical University Medical Faculty , Trabzon , Turkey., Aydin D; k Okmeydani Training and Research Hospital , Istanbul , Turkey., Pehlivan M; l Department of Internal Medicine , Gaziantep University Medical Faculty , Gaziantep , Turkey., Undar B; m Department of Internal Medicine , Dokuz Eylul University Medical Faculty , Izmir , Turkey., Dagdas S; n Department of Internal Medicine , Ankara Numune Training and Research Hospital , Ankara , Turkey., Ayyildiz O; o Medical Faculty Hospital, Department of Internal Medicine , Dicle University , Diyarbakir , Turkey., Akkaynak DZ; p Novartis Pharmaceuticals Corporation , Istanbul , Turkey., Dag IM; p Novartis Pharmaceuticals Corporation , Istanbul , Turkey., Ilhan O; q Ankara University School of Medicine , Ankara , Turkey.
Jazyk:	angličtina
Zdroj:	Expert opinion on pharmacotherapy [Expert Opin Pharmacother] 2016 Oct; Vol. 17 (14), pp. 1851-8. Date of Electronic Publication: 2016 Aug 18.
DOI:	10.1080/14656566.2016.1219338
Abstrakt:	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.
Databáze:	MEDLINE
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