Real-world toxicity and efficacy of asciminib in heavily pretreated patients with chronic myeloid leukemia
Although tyrosine kinase inhibitors (TKIs) have improved the prognosis of chronic myeloid leukemia (CML), some patients do not respond to TKIs. We evaluated 21 patients with CML treated with asciminib, which is effective in heavily pretreated patients. The median age was 63 years (range 25–82). Four...
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| Veröffentlicht in: | International journal of hematology 2024-11, Vol.121 (2), p.187-193 |
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| creator | Ishii, Yoshimi Fujisawa, Shin Miyazaki, Takuya Nakajima, Yuki Matsumura, Ayako Fujimaki, Katsumichi Suzuki, Taisei Hagihara, Maki Tanaka, Marika Hashimoto, Chizuko Nakajima, Hideaki |
| description | Although tyrosine kinase inhibitors (TKIs) have improved the prognosis of chronic myeloid leukemia (CML), some patients do not respond to TKIs. We evaluated 21 patients with CML treated with asciminib, which is effective in heavily pretreated patients. The median age was 63 years (range 25–82). Fourteen patients (67%) had been treated with at least three TKIs (range 2–5 prior lines). The switch to asciminib was due to intolerance in 14 patients (67%) and failure in seven patients (33%). The median duration of asciminib exposure was 237 days. With a median follow-up of 273 days, three patients (14%) discontinued asciminib due to failure and two (10%) due to intolerance. Among the 20 evaluable patients, the cumulative rates of molecular response with a two-log reduction, major molecular response, and four-log reduction were 80%, 60%, and 15%, respectively. The six-month event-free survival rate was 74.7%. The most frequent adverse events were liver dysfunction (29%), elevated amylase levels (14%), and renal dysfunction (10%). No patient experienced cardiovascular events. Six patients (29%) experienced cross-intolerance to asciminib, a rate similar to that for previous TKIs. Our study supports the efficacy and tolerability of asciminib in heavily pretreated CML patients in real-world settings. |
| doi_str_mv | 10.1007/s12185-024-03873-2 |
| format | Article |
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We evaluated 21 patients with CML treated with asciminib, which is effective in heavily pretreated patients. The median age was 63 years (range 25–82). Fourteen patients (67%) had been treated with at least three TKIs (range 2–5 prior lines). The switch to asciminib was due to intolerance in 14 patients (67%) and failure in seven patients (33%). The median duration of asciminib exposure was 237 days. With a median follow-up of 273 days, three patients (14%) discontinued asciminib due to failure and two (10%) due to intolerance. Among the 20 evaluable patients, the cumulative rates of molecular response with a two-log reduction, major molecular response, and four-log reduction were 80%, 60%, and 15%, respectively. The six-month event-free survival rate was 74.7%. The most frequent adverse events were liver dysfunction (29%), elevated amylase levels (14%), and renal dysfunction (10%). No patient experienced cardiovascular events. Six patients (29%) experienced cross-intolerance to asciminib, a rate similar to that for previous TKIs. Our study supports the efficacy and tolerability of asciminib in heavily pretreated CML patients in real-world settings.</description><identifier>ISSN: 0925-5710</identifier><identifier>ISSN: 1865-3774</identifier><identifier>EISSN: 1865-3774</identifier><identifier>DOI: 10.1007/s12185-024-03873-2</identifier><identifier>PMID: 39560911</identifier><language>eng</language><publisher>Singapore: Springer Nature Singapore</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents - adverse effects ; Antineoplastic Agents - therapeutic use ; Chronic myeloid leukemia ; Effectiveness ; Female ; Follow-Up Studies ; Hematology ; Humans ; Intolerance ; Kinases ; Leukemia ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive - drug therapy ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive - mortality ; Liver diseases ; Male ; Medical prognosis ; Medicine ; Medicine & Public Health ; Middle Aged ; Myeloid leukemia ; Niacinamide - analogs & derivatives ; Oncology ; Original Article ; Protein Kinase Inhibitors - adverse effects ; Protein Kinase Inhibitors - therapeutic use ; Pyrazoles ; Renal function ; Toxicity ; Treatment Outcome ; Tyrosine ; Tyrosine kinase inhibitors</subject><ispartof>International journal of hematology, 2024-11, Vol.121 (2), p.187-193</ispartof><rights>Japanese Society of Hematology 2024 Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</rights><rights>2024. Japanese Society of Hematology.</rights><rights>Copyright Springer Nature B.V. 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We evaluated 21 patients with CML treated with asciminib, which is effective in heavily pretreated patients. The median age was 63 years (range 25–82). Fourteen patients (67%) had been treated with at least three TKIs (range 2–5 prior lines). The switch to asciminib was due to intolerance in 14 patients (67%) and failure in seven patients (33%). The median duration of asciminib exposure was 237 days. With a median follow-up of 273 days, three patients (14%) discontinued asciminib due to failure and two (10%) due to intolerance. Among the 20 evaluable patients, the cumulative rates of molecular response with a two-log reduction, major molecular response, and four-log reduction were 80%, 60%, and 15%, respectively. The six-month event-free survival rate was 74.7%. The most frequent adverse events were liver dysfunction (29%), elevated amylase levels (14%), and renal dysfunction (10%). No patient experienced cardiovascular events. Six patients (29%) experienced cross-intolerance to asciminib, a rate similar to that for previous TKIs. Our study supports the efficacy and tolerability of asciminib in heavily pretreated CML patients in real-world settings.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Chronic myeloid leukemia</subject><subject>Effectiveness</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Hematology</subject><subject>Humans</subject><subject>Intolerance</subject><subject>Kinases</subject><subject>Leukemia</subject><subject>Leukemia, Myelogenous, Chronic, BCR-ABL Positive - drug therapy</subject><subject>Leukemia, Myelogenous, Chronic, BCR-ABL Positive - mortality</subject><subject>Liver diseases</subject><subject>Male</subject><subject>Medical prognosis</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Myeloid leukemia</subject><subject>Niacinamide - analogs & derivatives</subject><subject>Oncology</subject><subject>Original Article</subject><subject>Protein Kinase Inhibitors - adverse effects</subject><subject>Protein Kinase Inhibitors - therapeutic use</subject><subject>Pyrazoles</subject><subject>Renal function</subject><subject>Toxicity</subject><subject>Treatment Outcome</subject><subject>Tyrosine</subject><subject>Tyrosine kinase inhibitors</subject><issn>0925-5710</issn><issn>1865-3774</issn><issn>1865-3774</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kUtv1DAUhS0EokPhD7BAltiwMb1-Jc4SVYUiVUKqYG157GvGQxIPdtKSf9-UKSCx6Oou7nfOfRxCXnN4zwHas8oFN5qBUAykaSUTT8iGm0Yz2bbqKdlAJzTTLYcT8qLWPQBvQbXPyYnsdAMd5xuyv0bXs9tc-kCn_Cv5NC3UjYFijMk7v9Acqas-DWlMW5pGukN3k_qFHgpOBd2EgR7clHCcKr1N0476Xclj8nRYsM8p0B7nHzgk95I8i66v-OqhnpJvHy--nl-yqy-fPp9_uGJe6GZiIhj03imIDjQ3fj0Nu7BtAvgQZUTjvPFmGwRXLjbadUobVK0C7KSWXMlT8u7oeyj554x1skOqHvvejZjnaiWXIDhvunv07X_oPs9lXLdbqYY3CpSWKyWOlC-51oLRHkoaXFksB3ufhD0mYdck7O8krFhFbx6s5-2A4a_kz-tXQB6BurbG71j-zX7E9g7GiZT5</recordid><startdate>20241119</startdate><enddate>20241119</enddate><creator>Ishii, Yoshimi</creator><creator>Fujisawa, Shin</creator><creator>Miyazaki, Takuya</creator><creator>Nakajima, Yuki</creator><creator>Matsumura, Ayako</creator><creator>Fujimaki, Katsumichi</creator><creator>Suzuki, Taisei</creator><creator>Hagihara, Maki</creator><creator>Tanaka, Marika</creator><creator>Hashimoto, Chizuko</creator><creator>Nakajima, Hideaki</creator><general>Springer Nature Singapore</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7T7</scope><scope>7TM</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>P64</scope><scope>7X8</scope></search><sort><creationdate>20241119</creationdate><title>Real-world toxicity and efficacy of asciminib in heavily pretreated patients with chronic myeloid leukemia</title><author>Ishii, Yoshimi ; 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We evaluated 21 patients with CML treated with asciminib, which is effective in heavily pretreated patients. The median age was 63 years (range 25–82). Fourteen patients (67%) had been treated with at least three TKIs (range 2–5 prior lines). The switch to asciminib was due to intolerance in 14 patients (67%) and failure in seven patients (33%). The median duration of asciminib exposure was 237 days. With a median follow-up of 273 days, three patients (14%) discontinued asciminib due to failure and two (10%) due to intolerance. Among the 20 evaluable patients, the cumulative rates of molecular response with a two-log reduction, major molecular response, and four-log reduction were 80%, 60%, and 15%, respectively. The six-month event-free survival rate was 74.7%. The most frequent adverse events were liver dysfunction (29%), elevated amylase levels (14%), and renal dysfunction (10%). No patient experienced cardiovascular events. Six patients (29%) experienced cross-intolerance to asciminib, a rate similar to that for previous TKIs. Our study supports the efficacy and tolerability of asciminib in heavily pretreated CML patients in real-world settings.</abstract><cop>Singapore</cop><pub>Springer Nature Singapore</pub><pmid>39560911</pmid><doi>10.1007/s12185-024-03873-2</doi><tpages>7</tpages></addata></record> |
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| subjects | Adult Aged Aged, 80 and over Antineoplastic Agents - adverse effects Antineoplastic Agents - therapeutic use Chronic myeloid leukemia Effectiveness Female Follow-Up Studies Hematology Humans Intolerance Kinases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive - drug therapy Leukemia, Myelogenous, Chronic, BCR-ABL Positive - mortality Liver diseases Male Medical prognosis Medicine Medicine & Public Health Middle Aged Myeloid leukemia Niacinamide - analogs & derivatives Oncology Original Article Protein Kinase Inhibitors - adverse effects Protein Kinase Inhibitors - therapeutic use Pyrazoles Renal function Toxicity Treatment Outcome Tyrosine Tyrosine kinase inhibitors |
| title | Real-world toxicity and efficacy of asciminib in heavily pretreated patients with chronic myeloid leukemia |
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