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KMID : 1142020220570020144
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Blood Research
2022 Volume.57 No. 2 p.144 ~ p.151
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Safety and efficacy of nilotinib in adult patients with chronic myeloid leukemia: a post-marketing surveillance study in Korea
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Ahn Seo-Yeon
Son Sang-Kyun
Lee Gyu-Hyung
Kim In-Ho
Cheong June-Won
Lee Won-Sik
Kim Byung-Soo
Jo Deog-Yeon
Jung Chul-Won
Seong Chu-Myoung
Lee Jae-Hoon
Yuh Young-Jin
Kim Min-Kyoung
Ryoo Hun-Mo
Park Moo-Rim
Cho Su-Hee
Kim Hoon-Gu
Zang Dae-Young
Park Jinny
Kim Hawk
Lee Se-Ryeon
Kim Sung-Hyun
Chang Myung-Hee
Lee Ho-Sup
Choi Chul-Won
Kwon Ji-Hyun
Lim Sung-Nam
Oh Suk-Joong
Joo In-Kyung
Kim Dong-Wook
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Abstract
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Background: Nilotinib is a tyrosine kinase inhibitor approved by the Ministry of Food and Drug Safety for frontline and 2nd line treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). This study aimed to confirm the safety and efficacy of nilotinib in routine clinical practice within South Korea.
Methods: An open-label, multicenter, single-arm, 12-week observational post-marketing surveillance (PMS) study was conducted on 669 Korean adult patients with Ph+ CML from December 24, 2010, to December 23, 2016. The patients received nilotinib treatment in routine clinical practice settings. Safety was evaluated by all types of adverse events (AEs) during the study period, and efficacy was evaluated by the complete hematological response (CHR) and cytogenetic response.
Results: During the study period, AEs occurred in 61.3% (410 patients, 973 events), adverse drug reactions (ADRs) in 40.5% (271/669 patients, 559 events), serious AEs in 4.5% (30 patients, 37 events), and serious ADRs in 0.7% (5 patients, 8 events). Furthermore, unexpected AEs occurred at a rate of 6.9% (46 patients, 55 events) and unexpected ADRs at 1.2% (8 patients, 8 events). As for the efficacy results, CHR was achieved in 89.5% (442/494 patients), and minor cytogenetic response or major cytogenetic response was achieved in 85.8% (139/162 patients).
Conclusion: This PMS study shows consistent results in terms of safety and efficacy compared with previous studies. Nilotinib was well tolerated and efficacious in adult Korean patients with Ph+ CML in routine clinical practice settings.
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KEYWORD
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Nilotinib, Tyrosine kinase inhibitor, Chronic myeloid leukemia, Philadelphia chromosome positive, Post-marketing surveillance
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