Yu Lu, Li Weiming, Xu Na, Liu Xiaoli, Liu Bingcheng, Zhang Yanli, Meng Li, Zhu Huanling, Du Xin, Chen Suning, Hu Yu, Song Yongping, Men Lichuang, Jiang Qian
Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing, China.
Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Cancer. 2025 Jan 1;131(1):e35652. doi: 10.1002/cncr.35652. Epub 2024 Nov 26.
The objective of this study was to assess patient-reported outcomes (PROs), including health-related quality of life (HRQoL) and anxiety and depression symptoms, and to identify associated variables in patients with tyrosine kinase inhibitor (TKI)-resistant chronic myeloid leukemia (CML) in chronic-phase (CP) or accelerated-phase (AP) who were receiving olverembatinib.
Patients in multicenter studies were invited to complete the European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 Questionnaire, the Self-Rating Anxiety Scale, and the Self-Rating Depression Scale at baseline and regularly during olverembatinib therapy. The time trends in PROs were estimated with a linear model using a generalized estimating equation based on an independent working correlation matrix. A generalized estimating equation model was used to assess the variables associated with PROs.
In total, 146 patients with CML-CP or CML-AP were included in this study. Scores on seven items from the European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 Questionnaire, including global health, physical functioning, emotional functioning, fatigue, dyspnea, diarrhea, and financial difficulties, improved significantly over time during olverembatinib therapy. In multivariate analysis, age younger than 40 years was significantly associated with greater improvement in social functioning (p = .033), and CML-CP (vs. CML-AP) was associated with greater improvements in dyspnea (p = .031) and diarrhea (p = .031) over time. Scores on the Self-Rating Anxiety Scale and the Self-Rating Depression Scale decreased significantly over time during olverembatinib treatment (p < .001).
The authors concluded that HRQoL significantly improved over time during olverembatinib therapy in heavily treated patients with TKI-resistant CML, especially among those who were younger and those who had CML-CP. Anxiety symptoms also significantly decreased over time.
本研究的目的是评估患者报告的结局(PROs),包括健康相关生活质量(HRQoL)以及焦虑和抑郁症状,并确定接受奥雷巴替尼治疗的慢性期(CP)或加速期(AP)酪氨酸激酶抑制剂(TKI)耐药慢性髓性白血病(CML)患者的相关变量。
多中心研究中的患者被邀请在基线时以及奥雷巴替尼治疗期间定期完成欧洲癌症研究与治疗组织生活质量核心30问卷、自评焦虑量表和自评抑郁量表。使用基于独立工作相关矩阵的广义估计方程的线性模型估计PROs的时间趋势。使用广义估计方程模型评估与PROs相关的变量。
本研究共纳入146例CML-CP或CML-AP患者。欧洲癌症研究与治疗组织生活质量核心30问卷中包括总体健康、身体功能、情绪功能、疲劳、呼吸困难、腹泻和经济困难在内的七个项目的得分在奥雷巴替尼治疗期间随时间显著改善。在多变量分析中,年龄小于40岁与社会功能的更大改善显著相关(p = .033),随着时间推移,CML-CP(与CML-AP相比)与呼吸困难(p = .031)和腹泻(p = .031)的更大改善相关。在奥雷巴替尼治疗期间,自评焦虑量表和自评抑郁量表的得分随时间显著下降(p < .001)。
作者得出结论,在接受大量治疗的TKI耐药CML患者中,奥雷巴替尼治疗期间HRQoL随时间显著改善,尤其是在年轻患者和CML-CP患者中。焦虑症状也随时间显著减少。