https://scholars.lib.ntu.edu.tw/handle/123456789/635382
標題: | NOVEL-1st: an observational study to assess the safety and efficacy of nilotinib in newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase in Taiwan | 作者: | Hwang, Wen-Li Chen, Tsung-Chih Lin, Hsuan-Yu Chang, Ming-Chih Hsiao, Pei-Ching Bai, Li-Yuan Kuo, Ching-Yuan Chen, Yeu-Chin Liu, Ta-Chih Gau, Jyh-Pyng Wang, Po-Nan Hwang, Wei-Shou Kuo, Ming-Chung Liu, Chun-Yu Liu, Yi-Chang Ma, Ming-Chun Su, Nai-Wen Wang, Chuan-Cheng Wu, Yi-Ying MING YAO Yeh, Su-Peng Cheng, Hao-Wei Lee, Yee-Ming Ku, Fan-Chen JIH-LUH TANG |
關鍵字: | Chronic myeloid leukemia; First-line treatment; Nilotinib; Real-world setting | 公開日期: | 五月-2022 | 卷: | 115 | 期: | 5 | 起(迄)頁: | 704 | 來源出版物: | International journal of hematology | 摘要: | Nilotinib 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. |
URI: | https://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=0064b2b0a8229fdc48c17af3457a210c https://scholars.lib.ntu.edu.tw/handle/123456789/635382 |
ISSN: | 09255710 | DOI: | 10.1007/s12185-022-03311-1 |
顯示於: | 醫學系 |
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