Hwang, Wen-LiWen-LiHwangChen, Tsung-ChihTsung-ChihChenLin, Hsuan-YuHsuan-YuLinChang, Ming-ChihMing-ChihChangHsiao, Pei-ChingPei-ChingHsiaoBai, Li-YuanLi-YuanBaiKuo, Ching-YuanChing-YuanKuoChen, Yeu-ChinYeu-ChinChenLiu, Ta-ChihTa-ChihLiuGau, Jyh-PyngJyh-PyngGauWang, Po-NanPo-NanWangHwang, Wei-ShouWei-ShouHwangKuo, Ming-ChungMing-ChungKuoLiu, Chun-YuChun-YuLiuLiu, Yi-ChangYi-ChangLiuMa, Ming-ChunMing-ChunMaSu, Nai-WenNai-WenSuWang, Chuan-ChengChuan-ChengWangWu, Yi-YingYi-YingWuMING YAOYeh, Su-PengSu-PengYehCheng, Hao-WeiHao-WeiChengLee, Yee-MingYee-MingLeeKu, Fan-ChenFan-ChenKuJIH-LUH TANG2023-09-142023-09-142022-0509255710https://pubmed.ncbi.nlm.nih.gov/35212915/https://www.scopus.com/inward/record.uri?eid=2-s2.0-85125252708&doi=10.1007%2fs12185-022-03311-1&partnerID=40&md5=0064b2b0a8229fdc48c17af3457a210chttps://scholars.lib.ntu.edu.tw/handle/123456789/635382Nilotinib has been approved for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). However, the real-world evidence of nilotinib in newly diagnosed untreated Ph+ CML-CP is limited in Taiwan. The NOVEL-1st study was a non-interventional, multi-center study collecting long-term safety and effectiveness data in patients with newly diagnosed and untreated Ph+ CML-CP receiving nilotinib. We enrolled 129 patients from 11 hospitals. Overall, 1,466 adverse events (AEs) were reported; among these, 151 were serious and 524 were nilotinib-related. Common hematological AEs were thrombocytopenia (31.0%), anemia (20.9%), and leukopenia (14.0%); common nilotinib-related AEs were thrombocytopenia (29.5%), anemia (14.7%), and leukopenia (12.4%). Early molecular response, defined as BCR-ABL ≤ 10% at Month 3, was seen in 87.6% of patients. By 36 months, the cumulative rates of complete hematologic response, complete cytogenetic response, major molecular response, molecular response 4.0-log reduction, and molecular response 4.5-log reduction were 98.5, 92.5, 85.8, 65.0, and 45.0%, respectively. Nilotinib is effective and well-tolerated in patients with newly diagnosed Ph+ CML-CP in the real-world setting. Long-term holistic care and a highly tolerable AE profile may contribute to good treatment outcomes in Ph+ CML-CP under first-line treatment with nilotinib.enChronic myeloid leukemia; First-line treatment; Nilotinib; Real-world settingjournal article10.1007/s12185-022-03311-1352129152-s2.0-85125252708https://api.elsevier.com/content/abstract/scopus_id/85125252708