| Autor: |
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, Yao, Ming |
| Zdroj: |
International Journal of Hematology; May2022, Vol. 115 Issue 5, p704-712, 9p |
| Abstrakt: |
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. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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