Italian Group for Adult Hematologic Diseases (GIMEMA), Data Center and Health Outcomes Research Unit, Rome, Italy.
Hematology Section with BMT Unit, AOU Policlinico-V. Emanuele, Catania, Italy.
Leukemia. 2020 Feb;34(2):488-498. doi: 10.1038/s41375-019-0563-0. Epub 2019 Sep 2.
There is paucity of evidence-based data on health-related quality of life (HRQOL) outcomes of chronic myeloid leukemia (CML) patients treated with tyrosine kinase inhibitors (TKIs). We performed a multicenter propensity-matched case-control study to compare HRQOL of newly diagnosed CML patients treated with front-line dasatinib (cases) or imatinib (controls). Patient-reported HRQOL was assessed with the EORTC QLQ-C30 and the EORTC QLQ-CML24 questionnaires. The impact on daily life scale of the EORTC QLQ-CML24 was selected a priori in the protocol as the primary HRQOL scale for the comparative analysis. Overall, 323 CML patients were enrolled of whom 223 in therapy with imatinib and 100 in therapy with dasatinib. Patients treated with dasatinib reported better disease-specific HRQOL outcomes in impact on daily life (Δ = 8.72, 95% confidence interval [CI]: 3.17-14.27, p = 0.002), satisfaction with social life (Δ = 13.45, 95% CI: 5.82-21.08, p = 0.001), and symptom burden (Δ = 7.69, 95% CI: 3.42-11.96, p = 0.001). Analysis by age groups showed that, in patients aged 60 years and over, differences favoring dasatinib were negligible across several cancer generic and disease-specific HRQOL domains. Our findings provide novel comparative HRQOL data that extends knowledge on safety and efficacy of these two TKIs and may help to facilitate first-line treatment decisions.
有关接受酪氨酸激酶抑制剂 (TKI) 治疗的慢性髓性白血病 (CML) 患者健康相关生活质量 (HRQOL) 结局的循证数据很少。我们进行了一项多中心倾向匹配病例对照研究,以比较一线使用达沙替尼 (病例组) 或伊马替尼 (对照组) 治疗的新诊断 CML 患者的 HRQOL。采用 EORTC QLQ-C30 和 EORTC QLQ-CML24 问卷评估患者报告的 HRQOL。EORTC QLQ-CML24 的日常生活影响量表在方案中预先选择为比较分析的主要 HRQOL 量表。共有 323 名 CML 患者入组,其中 223 名接受伊马替尼治疗,100 名接受达沙替尼治疗。接受达沙替尼治疗的患者在日常生活影响 (Δ = 8.72,95%置信区间 [CI]:3.17-14.27,p = 0.002)、社会生活满意度 (Δ = 13.45,95% CI:5.82-21.08,p = 0.001) 和症状负担 (Δ = 7.69,95% CI:3.42-11.96,p = 0.001) 方面的疾病特异性 HRQOL 结局更好。按年龄组分析显示,在 60 岁及以上的患者中,达沙替尼在几个癌症通用和疾病特异性 HRQOL 领域的优势差异可以忽略不计。我们的研究结果提供了新的比较 HRQOL 数据,扩展了这两种 TKI 的安全性和疗效知识,并可能有助于促进一线治疗决策。