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
Abstract 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..
| Medienart: |
Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:115 |
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| Enthalten in: |
International journal of hematology - 115(2022), 5 vom: 25. Feb., Seite 704-712 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Hwang, Wen-Li [VerfasserIn] |
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| Links: |
Volltext [lizenzpflichtig] |
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| Themen: |
Chronic myeloid leukemia |
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| Anmerkungen: |
© Japanese Society of Hematology 2022 |
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| doi: |
10.1007/s12185-022-03311-1 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
OLC2078548537 |
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| 520 | |a Abstract 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. | ||
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| 700 | 1 | |a Chen, Tsung-Chih |4 aut | |
| 700 | 1 | |a Lin, Hsuan-Yu |4 aut | |
| 700 | 1 | |a Chang, Ming-Chih |4 aut | |
| 700 | 1 | |a Hsiao, Pei-Ching |4 aut | |
| 700 | 1 | |a Bai, Li-Yuan |4 aut | |
| 700 | 1 | |a Kuo, Ching-Yuan |4 aut | |
| 700 | 1 | |a Chen, Yeu-Chin |4 aut | |
| 700 | 1 | |a Liu, Ta-Chih |4 aut | |
| 700 | 1 | |a Gau, Jyh-Pyng |4 aut | |
| 700 | 1 | |a Wang, Po-Nan |4 aut | |
| 700 | 1 | |a Hwang, Wei-Shou |4 aut | |
| 700 | 1 | |a Kuo, Ming-Chung |4 aut | |
| 700 | 1 | |a Liu, Chun-Yu |4 aut | |
| 700 | 1 | |a Liu, Yi-Chang |4 aut | |
| 700 | 1 | |a Ma, Ming-Chun |4 aut | |
| 700 | 1 | |a Su, Nai-Wen |4 aut | |
| 700 | 1 | |a Wang, Chuan-Cheng |4 aut | |
| 700 | 1 | |a Wu, Yi-Ying |4 aut | |
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| 700 | 1 | |a Yeh, Su-Peng |4 aut | |
| 700 | 1 | |a Cheng, Hao-Wei |4 aut | |
| 700 | 1 | |a Lee, Yee-Ming |4 aut | |
| 700 | 1 | |a Ku, Fan-Chen |4 aut | |
| 700 | 1 | |a Tang, Jih-Luh |0 (orcid)0000-0003-4021-3281 |4 aut | |
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