Divison of Hematology, Hamamatsu University School of Medicine, Shizuoka, Japan.
Department of Hematology, Nephrology, and Rheumatology, Akita University School of Medicine, Akita, Japan.
Cancer Sci. 2020 Oct;111(10):3714-3725. doi: 10.1111/cas.14580. Epub 2020 Aug 12.
Comorbidities at diagnosis among patients with chronic myeloid leukemia in chronic phase (CML-CP) may affect their overall survival (OS) rate even in the tyrosine kinase inhibitor (TKI) era. However, the prognostic impact of comorbidities in patients with CML-CP treated with a second-generation TKI (2GTKI) has not been elucidated. We evaluated the effect of comorbidities on survival using the Charlson Comorbidity Index (CCI) in patients with CML-CP treated with imatinib or a 2GTKI (nilotinib and dasatinib). From April 2010 to March 2013, 506 patients with CML-CP were registered for the population-based cohort study, and 452 with a median age of 56 y were assessable. Treatment groups included 139 patients receiving imatinib, 169 receiving nilotinib, and 144 receiving dasatinib. Comorbidities were diagnosed in 99 patients. CCI scores were stratified as follows: 2, 353 patients; 3, 72 patients; and ≥4, 27 patients. Treatment response did not vary relative to CCI scores. However, across the entire cohort, the OS rate was significantly lower among patients with higher CCI scores than in those with a CCI score of 2 (94.4% in score 2, 89.0% in score 3, and 72.8% in score ≥4; P < .001). Multivariate analysis identified a CCI score of ≥4 as a strong adverse prognostic factor for OS rather than the disease-specific risk factor, older age, performance status, or selection of TKI (Wald test, P < .01). Our results demonstrated that comorbidities at diagnosis were the most important predictive factor for successful treatment, regardless of the TKI type used in CML-CP. This trial was registered at UMIN-CTR as 00003581.
在酪氨酸激酶抑制剂（TKI）时代，慢性期慢性髓系白血病（CML-CP）患者的合并症可能会影响其总生存（OS）率。然而，在接受第二代 TKI（2GTKI）治疗的 CML-CP 患者中，合并症的预后影响尚未阐明。我们使用 Charlson 合并症指数（CCI）评估了 CML-CP 患者接受伊马替尼或 2GTKI（尼洛替尼和达沙替尼）治疗时的生存情况。从 2010 年 4 月至 2013 年 3 月，对 506 名 CML-CP 患者进行了基于人群的队列研究登记，其中 452 名患者的中位年龄为 56 岁，可评估。治疗组包括 139 名接受伊马替尼治疗的患者、169 名接受尼洛替尼治疗的患者和 144 名接受达沙替尼治疗的患者。99 名患者被诊断患有合并症。CCI 评分分为以下几类：2，353 例；3，72 例；和≥4，27 例。治疗反应与 CCI 评分无关。然而，在整个队列中，CCI 评分较高的患者的 OS 率明显低于 CCI 评分为 2 的患者（CCI 评分为 2 的患者为 94.4%，CCI 评分为 3 的患者为 89.0%，CCI 评分为≥4 的患者为 72.8%；P<.001）。多变量分析确定 CCI 评分≥4 是 OS 的一个强烈不利预后因素，而不是疾病特异性危险因素、年龄较大、表现状态或 TKI 的选择（Wald 检验，P<.01）。我们的结果表明，诊断时的合并症是成功治疗的最重要预测因素，而与 CML-CP 中使用的 TKI 类型无关。该试验在 UMIN-CTR 注册为 00003581。
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