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-i...
Ausführliche Beschreibung
Autor*in: |
Hwang, Wen-Li [verfasserIn] |
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Format: |
E-Artikel |
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Sprache: |
Englisch |
Erschienen: |
2022 |
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Schlagwörter: |
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Anmerkung: |
© Japanese Society of Hematology 2022 |
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Übergeordnetes Werk: |
Enthalten in: International journal of hematology - Tokyo [u.a.] : Springer, 1995, 115(2022), 5 vom: 25. Feb., Seite 704-712 |
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Übergeordnetes Werk: |
volume:115 ; year:2022 ; number:5 ; day:25 ; month:02 ; pages:704-712 |
Links: |
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DOI / URN: |
10.1007/s12185-022-03311-1 |
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Katalog-ID: |
SPR046858369 |
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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. | ||
650 | 4 | |a Chronic myeloid leukemia |7 (dpeaa)DE-He213 | |
650 | 4 | |a First-line treatment |7 (dpeaa)DE-He213 | |
650 | 4 | |a Nilotinib |7 (dpeaa)DE-He213 | |
650 | 4 | |a Real-world setting |7 (dpeaa)DE-He213 | |
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 | |
700 | 1 | |a Yao, Ming |4 aut | |
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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10.1007/s12185-022-03311-1 doi (DE-627)SPR046858369 (SPR)s12185-022-03311-1-e DE-627 ger DE-627 rakwb eng Hwang, Wen-Li verfasserin aut 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Japanese Society of Hematology 2022 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. Chronic myeloid leukemia (dpeaa)DE-He213 First-line treatment (dpeaa)DE-He213 Nilotinib (dpeaa)DE-He213 Real-world setting (dpeaa)DE-He213 Chen, Tsung-Chih aut Lin, Hsuan-Yu aut Chang, Ming-Chih aut Hsiao, Pei-Ching aut Bai, Li-Yuan aut Kuo, Ching-Yuan aut Chen, Yeu-Chin aut Liu, Ta-Chih aut Gau, Jyh-Pyng aut Wang, Po-Nan aut Hwang, Wei-Shou aut Kuo, Ming-Chung aut Liu, Chun-Yu aut Liu, Yi-Chang aut Ma, Ming-Chun aut Su, Nai-Wen aut Wang, Chuan-Cheng aut Wu, Yi-Ying aut Yao, Ming aut Yeh, Su-Peng aut Cheng, Hao-Wei aut Lee, Yee-Ming aut Ku, Fan-Chen aut Tang, Jih-Luh (orcid)0000-0003-4021-3281 aut Enthalten in International journal of hematology Tokyo [u.a.] : Springer, 1995 115(2022), 5 vom: 25. Feb., Seite 704-712 (DE-627)324615485 (DE-600)2028991-1 1865-3774 nnns volume:115 year:2022 number:5 day:25 month:02 pages:704-712 https://dx.doi.org/10.1007/s12185-022-03311-1 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 115 2022 5 25 02 704-712 |
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10.1007/s12185-022-03311-1 doi (DE-627)SPR046858369 (SPR)s12185-022-03311-1-e DE-627 ger DE-627 rakwb eng Hwang, Wen-Li verfasserin aut 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Japanese Society of Hematology 2022 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. Chronic myeloid leukemia (dpeaa)DE-He213 First-line treatment (dpeaa)DE-He213 Nilotinib (dpeaa)DE-He213 Real-world setting (dpeaa)DE-He213 Chen, Tsung-Chih aut Lin, Hsuan-Yu aut Chang, Ming-Chih aut Hsiao, Pei-Ching aut Bai, Li-Yuan aut Kuo, Ching-Yuan aut Chen, Yeu-Chin aut Liu, Ta-Chih aut Gau, Jyh-Pyng aut Wang, Po-Nan aut Hwang, Wei-Shou aut Kuo, Ming-Chung aut Liu, Chun-Yu aut Liu, Yi-Chang aut Ma, Ming-Chun aut Su, Nai-Wen aut Wang, Chuan-Cheng aut Wu, Yi-Ying aut Yao, Ming aut Yeh, Su-Peng aut Cheng, Hao-Wei aut Lee, Yee-Ming aut Ku, Fan-Chen aut Tang, Jih-Luh (orcid)0000-0003-4021-3281 aut Enthalten in International journal of hematology Tokyo [u.a.] : Springer, 1995 115(2022), 5 vom: 25. Feb., Seite 704-712 (DE-627)324615485 (DE-600)2028991-1 1865-3774 nnns volume:115 year:2022 number:5 day:25 month:02 pages:704-712 https://dx.doi.org/10.1007/s12185-022-03311-1 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 115 2022 5 25 02 704-712 |
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10.1007/s12185-022-03311-1 doi (DE-627)SPR046858369 (SPR)s12185-022-03311-1-e DE-627 ger DE-627 rakwb eng Hwang, Wen-Li verfasserin aut 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Japanese Society of Hematology 2022 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. Chronic myeloid leukemia (dpeaa)DE-He213 First-line treatment (dpeaa)DE-He213 Nilotinib (dpeaa)DE-He213 Real-world setting (dpeaa)DE-He213 Chen, Tsung-Chih aut Lin, Hsuan-Yu aut Chang, Ming-Chih aut Hsiao, Pei-Ching aut Bai, Li-Yuan aut Kuo, Ching-Yuan aut Chen, Yeu-Chin aut Liu, Ta-Chih aut Gau, Jyh-Pyng aut Wang, Po-Nan aut Hwang, Wei-Shou aut Kuo, Ming-Chung aut Liu, Chun-Yu aut Liu, Yi-Chang aut Ma, Ming-Chun aut Su, Nai-Wen aut Wang, Chuan-Cheng aut Wu, Yi-Ying aut Yao, Ming aut Yeh, Su-Peng aut Cheng, Hao-Wei aut Lee, Yee-Ming aut Ku, Fan-Chen aut Tang, Jih-Luh (orcid)0000-0003-4021-3281 aut Enthalten in International journal of hematology Tokyo [u.a.] : Springer, 1995 115(2022), 5 vom: 25. Feb., Seite 704-712 (DE-627)324615485 (DE-600)2028991-1 1865-3774 nnns volume:115 year:2022 number:5 day:25 month:02 pages:704-712 https://dx.doi.org/10.1007/s12185-022-03311-1 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 115 2022 5 25 02 704-712 |
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10.1007/s12185-022-03311-1 doi (DE-627)SPR046858369 (SPR)s12185-022-03311-1-e DE-627 ger DE-627 rakwb eng Hwang, Wen-Li verfasserin aut 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Japanese Society of Hematology 2022 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. Chronic myeloid leukemia (dpeaa)DE-He213 First-line treatment (dpeaa)DE-He213 Nilotinib (dpeaa)DE-He213 Real-world setting (dpeaa)DE-He213 Chen, Tsung-Chih aut Lin, Hsuan-Yu aut Chang, Ming-Chih aut Hsiao, Pei-Ching aut Bai, Li-Yuan aut Kuo, Ching-Yuan aut Chen, Yeu-Chin aut Liu, Ta-Chih aut Gau, Jyh-Pyng aut Wang, Po-Nan aut Hwang, Wei-Shou aut Kuo, Ming-Chung aut Liu, Chun-Yu aut Liu, Yi-Chang aut Ma, Ming-Chun aut Su, Nai-Wen aut Wang, Chuan-Cheng aut Wu, Yi-Ying aut Yao, Ming aut Yeh, Su-Peng aut Cheng, Hao-Wei aut Lee, Yee-Ming aut Ku, Fan-Chen aut Tang, Jih-Luh (orcid)0000-0003-4021-3281 aut Enthalten in International journal of hematology Tokyo [u.a.] : Springer, 1995 115(2022), 5 vom: 25. Feb., Seite 704-712 (DE-627)324615485 (DE-600)2028991-1 1865-3774 nnns volume:115 year:2022 number:5 day:25 month:02 pages:704-712 https://dx.doi.org/10.1007/s12185-022-03311-1 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 115 2022 5 25 02 704-712 |
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10.1007/s12185-022-03311-1 doi (DE-627)SPR046858369 (SPR)s12185-022-03311-1-e DE-627 ger DE-627 rakwb eng Hwang, Wen-Li verfasserin aut 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Japanese Society of Hematology 2022 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. Chronic myeloid leukemia (dpeaa)DE-He213 First-line treatment (dpeaa)DE-He213 Nilotinib (dpeaa)DE-He213 Real-world setting (dpeaa)DE-He213 Chen, Tsung-Chih aut Lin, Hsuan-Yu aut Chang, Ming-Chih aut Hsiao, Pei-Ching aut Bai, Li-Yuan aut Kuo, Ching-Yuan aut Chen, Yeu-Chin aut Liu, Ta-Chih aut Gau, Jyh-Pyng aut Wang, Po-Nan aut Hwang, Wei-Shou aut Kuo, Ming-Chung aut Liu, Chun-Yu aut Liu, Yi-Chang aut Ma, Ming-Chun aut Su, Nai-Wen aut Wang, Chuan-Cheng aut Wu, Yi-Ying aut Yao, Ming aut Yeh, Su-Peng aut Cheng, Hao-Wei aut Lee, Yee-Ming aut Ku, Fan-Chen aut Tang, Jih-Luh (orcid)0000-0003-4021-3281 aut Enthalten in International journal of hematology Tokyo [u.a.] : Springer, 1995 115(2022), 5 vom: 25. Feb., Seite 704-712 (DE-627)324615485 (DE-600)2028991-1 1865-3774 nnns volume:115 year:2022 number:5 day:25 month:02 pages:704-712 https://dx.doi.org/10.1007/s12185-022-03311-1 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 115 2022 5 25 02 704-712 |
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Enthalten in International journal of hematology 115(2022), 5 vom: 25. Feb., Seite 704-712 volume:115 year:2022 number:5 day:25 month:02 pages:704-712 |
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Enthalten in International journal of hematology 115(2022), 5 vom: 25. Feb., Seite 704-712 volume:115 year:2022 number:5 day:25 month:02 pages:704-712 |
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Chronic myeloid leukemia First-line treatment Nilotinib Real-world setting |
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International journal of hematology |
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Hwang, Wen-Li @@aut@@ Chen, Tsung-Chih @@aut@@ Lin, Hsuan-Yu @@aut@@ Chang, Ming-Chih @@aut@@ Hsiao, Pei-Ching @@aut@@ Bai, Li-Yuan @@aut@@ Kuo, Ching-Yuan @@aut@@ Chen, Yeu-Chin @@aut@@ Liu, Ta-Chih @@aut@@ Gau, Jyh-Pyng @@aut@@ Wang, Po-Nan @@aut@@ Hwang, Wei-Shou @@aut@@ Kuo, Ming-Chung @@aut@@ Liu, Chun-Yu @@aut@@ Liu, Yi-Chang @@aut@@ Ma, Ming-Chun @@aut@@ Su, Nai-Wen @@aut@@ Wang, Chuan-Cheng @@aut@@ Wu, Yi-Ying @@aut@@ Yao, Ming @@aut@@ Yeh, Su-Peng @@aut@@ Cheng, Hao-Wei @@aut@@ Lee, Yee-Ming @@aut@@ Ku, Fan-Chen @@aut@@ Tang, Jih-Luh @@aut@@ |
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<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">SPR046858369</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230508003821.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">220428s2022 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1007/s12185-022-03311-1</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR046858369</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s12185-022-03311-1-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Hwang, Wen-Li</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">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</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2022</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">© Japanese Society of Hematology 2022</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="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. 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|
author |
Hwang, Wen-Li |
spellingShingle |
Hwang, Wen-Li misc Chronic myeloid leukemia misc First-line treatment misc Nilotinib misc Real-world setting 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 |
authorStr |
Hwang, Wen-Li |
ppnlink_with_tag_str_mv |
@@773@@(DE-627)324615485 |
format |
electronic Article |
delete_txt_mv |
keep |
author_role |
aut aut aut aut aut aut aut aut aut aut aut aut aut aut aut aut aut aut aut aut aut aut aut aut aut |
collection |
springer |
remote_str |
true |
illustrated |
Not Illustrated |
issn |
1865-3774 |
topic_title |
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 Chronic myeloid leukemia (dpeaa)DE-He213 First-line treatment (dpeaa)DE-He213 Nilotinib (dpeaa)DE-He213 Real-world setting (dpeaa)DE-He213 |
topic |
misc Chronic myeloid leukemia misc First-line treatment misc Nilotinib misc Real-world setting |
topic_unstemmed |
misc Chronic myeloid leukemia misc First-line treatment misc Nilotinib misc Real-world setting |
topic_browse |
misc Chronic myeloid leukemia misc First-line treatment misc Nilotinib misc Real-world setting |
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title |
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 |
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(DE-627)SPR046858369 (SPR)s12185-022-03311-1-e |
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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 |
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Hwang, Wen-Li |
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International journal of hematology |
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International journal of hematology |
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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 Yeh, Su-Peng Cheng, Hao-Wei Lee, Yee-Ming Ku, Fan-Chen Tang, Jih-Luh |
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Elektronische Aufsätze |
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Hwang, Wen-Li |
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10.1007/s12185-022-03311-1 |
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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 |
title_auth |
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 |
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. © Japanese Society of Hematology 2022 |
abstractGer |
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. © Japanese Society of Hematology 2022 |
abstract_unstemmed |
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. © Japanese Society of Hematology 2022 |
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title_short |
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 |
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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 Yeh, Su-Peng Cheng, Hao-Wei Lee, Yee-Ming Ku, Fan-Chen Tang, Jih-Luh |
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score |
7.401457 |