Zi Wang, Congwei Jia, Xuan Wang, Yan Zhang, Daobin Zhou, Wei Zhang
{"title":"Orelabrutinib治疗慢性淋巴细胞白血病/小淋巴细胞淋巴瘤患者的真实世界结果：一项回顾性研究","authors":"Zi Wang, Congwei Jia, Xuan Wang, Yan Zhang, Daobin Zhou, Wei Zhang","doi":"10.1007/s12325-025-03344-y","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Orelabrutinib is a novel Bruton's tyrosine kinase inhibitor with high selectivity and a favorable safety profile. Despite substantial benefits in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with orelabrutinib, real-world data remain scarce. This study aimed to evaluate the efficacy and safety of orelabrutinib regimens for CLL/SLL in a real-world setting.</p><p><strong>Methods: </strong>Between June 1, 2018, and September 30, 2024, a total of 63 patients with CLL/SLL who received an orelabrutinib-based regimen were included in this retrospective study. Data on demographics and characteristics, treatment, outcomes, and safety were retrospectively collected and analyzed. Outcomes included overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.</p><p><strong>Results: </strong>Of the 63 included patients, 18 (28.6%) patients received orelabrutinib-based regimen as first-line therapy, 33 (52.4%) as second-line therapy, and 12 (19.0%) as third-line therapy. The ORR and DCR were 90.5% (57/63, 95% CI 80.4-96.4) and 96.8% (61/63, 95% CI: 89.0-99.6), respectively. Regarding different treatment lines, ORR was 94.4% (17/18) for first-line therapy, 93.9% (31/33) for second-line therapy, and 75.0% (9/12) for third-line therapy. At a median follow-up of 72.0 months (range: 24.0-216.0), the median PFS and OS were not reached. The 36-month PFS rate was 80.7% (95% CI 61.4-100.0) and the 36-month OS rate was 85.5% (95% CI 67.4-100.0). Thirty-eight (60.3%) patients experienced at least one adverse event (AE) of any grade during orelabrutinib therapy, with no treatment-related deaths observed. Among the 31 patients previously treated with ibrutinib/zanubrutinib, AEs reported during prior therapy mostly resolved or improved in severity after switching to orelabrutinib.</p><p><strong>Conclusion: </strong>Orelabrutinib was effective and well tolerated for patients with CLL/SLL, providing evidence of clinical benefit in real-world settings.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0000,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Real-World Outcomes with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: A Retrospective Study.\",\"authors\":\"Zi Wang, Congwei Jia, Xuan Wang, Yan Zhang, Daobin Zhou, Wei Zhang\",\"doi\":\"10.1007/s12325-025-03344-y\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Orelabrutinib is a novel Bruton's tyrosine kinase inhibitor with high selectivity and a favorable safety profile. Despite substantial benefits in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with orelabrutinib, real-world data remain scarce. This study aimed to evaluate the efficacy and safety of orelabrutinib regimens for CLL/SLL in a real-world setting.</p><p><strong>Methods: </strong>Between June 1, 2018, and September 30, 2024, a total of 63 patients with CLL/SLL who received an orelabrutinib-based regimen were included in this retrospective study. Data on demographics and characteristics, treatment, outcomes, and safety were retrospectively collected and analyzed. Outcomes included overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.</p><p><strong>Results: </strong>Of the 63 included patients, 18 (28.6%) patients received orelabrutinib-based regimen as first-line therapy, 33 (52.4%) as second-line therapy, and 12 (19.0%) as third-line therapy. The ORR and DCR were 90.5% (57/63, 95% CI 80.4-96.4) and 96.8% (61/63, 95% CI: 89.0-99.6), respectively. Regarding different treatment lines, ORR was 94.4% (17/18) for first-line therapy, 93.9% (31/33) for second-line therapy, and 75.0% (9/12) for third-line therapy. At a median follow-up of 72.0 months (range: 24.0-216.0), the median PFS and OS were not reached. The 36-month PFS rate was 80.7% (95% CI 61.4-100.0) and the 36-month OS rate was 85.5% (95% CI 67.4-100.0). Thirty-eight (60.3%) patients experienced at least one adverse event (AE) of any grade during orelabrutinib therapy, with no treatment-related deaths observed. Among the 31 patients previously treated with ibrutinib/zanubrutinib, AEs reported during prior therapy mostly resolved or improved in severity after switching to orelabrutinib.</p><p><strong>Conclusion: </strong>Orelabrutinib was effective and well tolerated for patients with CLL/SLL, providing evidence of clinical benefit in real-world settings.</p>\",\"PeriodicalId\":7482,\"journal\":{\"name\":\"Advances in Therapy\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":4.0000,\"publicationDate\":\"2025-09-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Advances in Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s12325-025-03344-y\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s12325-025-03344-y","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
摘要
Orelabrutinib是一种新型的布鲁顿酪氨酸激酶抑制剂，具有高选择性和良好的安全性。尽管orelabrutinib对慢性淋巴细胞白血病(CLL)/小淋巴细胞淋巴瘤（SLL）有显著的疗效，但实际数据仍然很少。本研究旨在评估orelabrutinib方案在现实世界中治疗CLL/SLL的有效性和安全性。方法：在2018年6月1日至2024年9月30日期间，共有63例接受奥瑞鲁替尼为基础的CLL/SLL患者纳入本回顾性研究。回顾性收集和分析了人口统计学和特征、治疗、结局和安全性的数据。结果包括总缓解率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）和安全性。结果：纳入的63例患者中，18例（28.6%）患者接受了以奥瑞布替尼为基础的一线治疗，33例（52.4%）患者接受了二线治疗，12例（19.0%）患者接受了三线治疗。ORR和DCR分别为90.5% （57/63,95% CI 80.4-96.4）和96.8% （61/63,95% CI: 89.0-99.6）。不同治疗线，一线治疗ORR为94.4%(17/18)，二线治疗ORR为93.9%(31/33)，三线治疗ORR为75.0%（9/12）。中位随访72.0个月（范围：24.0-216.0），中位PFS和OS均未达到。36个月的PFS率为80.7% (95% CI 61.4-100.0)， 36个月的OS率为85.5% （95% CI 67.4-100.0）。38例（60.3%）患者在接受奥瑞布替尼治疗期间至少经历了一次任何级别的不良事件（AE），未观察到与治疗相关的死亡。在先前接受伊鲁替尼/扎鲁替尼治疗的31例患者中，先前治疗期间报告的不良事件大多在改用奥瑞布替尼后缓解或严重程度改善。结论：Orelabrutinib对CLL/SLL患者有效且耐受性良好，在现实环境中提供了临床获益的证据。
Real-World Outcomes with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: A Retrospective Study.
Introduction: Orelabrutinib is a novel Bruton's tyrosine kinase inhibitor with high selectivity and a favorable safety profile. Despite substantial benefits in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with orelabrutinib, real-world data remain scarce. This study aimed to evaluate the efficacy and safety of orelabrutinib regimens for CLL/SLL in a real-world setting.
Methods: Between June 1, 2018, and September 30, 2024, a total of 63 patients with CLL/SLL who received an orelabrutinib-based regimen were included in this retrospective study. Data on demographics and characteristics, treatment, outcomes, and safety were retrospectively collected and analyzed. Outcomes included overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.
Results: Of the 63 included patients, 18 (28.6%) patients received orelabrutinib-based regimen as first-line therapy, 33 (52.4%) as second-line therapy, and 12 (19.0%) as third-line therapy. The ORR and DCR were 90.5% (57/63, 95% CI 80.4-96.4) and 96.8% (61/63, 95% CI: 89.0-99.6), respectively. Regarding different treatment lines, ORR was 94.4% (17/18) for first-line therapy, 93.9% (31/33) for second-line therapy, and 75.0% (9/12) for third-line therapy. At a median follow-up of 72.0 months (range: 24.0-216.0), the median PFS and OS were not reached. The 36-month PFS rate was 80.7% (95% CI 61.4-100.0) and the 36-month OS rate was 85.5% (95% CI 67.4-100.0). Thirty-eight (60.3%) patients experienced at least one adverse event (AE) of any grade during orelabrutinib therapy, with no treatment-related deaths observed. Among the 31 patients previously treated with ibrutinib/zanubrutinib, AEs reported during prior therapy mostly resolved or improved in severity after switching to orelabrutinib.
Conclusion: Orelabrutinib was effective and well tolerated for patients with CLL/SLL, providing evidence of clinical benefit in real-world settings.
期刊介绍：
Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
