Abstract：
BACKGROUND: There are limited data comprehensively comparing therapy responses and outcomes among nilotinib, dasatinib, flumatinib and imatinib for newly diagnosed chronic-phase chronic myeloid leukemia in a real-world setting.
METHODS: Data from patients with chronic-phase CML receiving initial a second-generation tyrosine-kinase inhibitor (2G-TKI, nilotinib, dasatinib or flumatinib) or imatinib therapy from 77 Chinese centers were retrospectively interrogated. Propensity-score matching (PSM) analyses were performed to to compare therapy responses and outcomes among these 4 TKIs.
RESULTS: 2,496 patients receiving initial nilotinib (n = 512), dasatinib (n = 134), flumatinib (n = 411) or imatinib (n = 1,439) therapy were retrospectively interrogated in this study. PSM analyses indicated that patients receiving initial nilotinib, dasatinib or flumatinib therapy had comparable cytogenetic and molecular responses (p = .28-.91) and survival outcomes including failure-free survival (FFS, p = .28-.43), progression-free survival (PFS, p = .19-.93) and overall survival (OS) (p values = .76-.78) but had significantly higher cumulative incidences of cytogenetic and molecular responses (all p values < .001) and higher probabilities of FFS (p < .001-.01) than those receiving imatinib therapy, despite comparable PFS (p = .18-.89) and OS (p = .23-.30).
CONCLUSIONS: Nilotinib, dasatinib and flumatinib had comparable efficacy, and significantly higher therapy responses and higher FFS rates than imatinib in newly diagnosed CML patients. However, there were no significant differences in PFS and OS among these 4 TKIs. These real-world data may provide additional evidence for routine clinical assessments to identify more appropriate therapies.
METHODS: Data from patients with chronic-phase CML receiving initial a second-generation tyrosine-kinase inhibitor (2G-TKI, nilotinib, dasatinib or flumatinib) or imatinib therapy from 77 Chinese centers were retrospectively interrogated. Propensity-score matching (PSM) analyses were performed to to compare therapy responses and outcomes among these 4 TKIs.
RESULTS: 2,496 patients receiving initial nilotinib (n = 512), dasatinib (n = 134), flumatinib (n = 411) or imatinib (n = 1,439) therapy were retrospectively interrogated in this study. PSM analyses indicated that patients receiving initial nilotinib, dasatinib or flumatinib therapy had comparable cytogenetic and molecular responses (p = .28-.91) and survival outcomes including failure-free survival (FFS, p = .28-.43), progression-free survival (PFS, p = .19-.93) and overall survival (OS) (p values = .76-.78) but had significantly higher cumulative incidences of cytogenetic and molecular responses (all p values < .001) and higher probabilities of FFS (p < .001-.01) than those receiving imatinib therapy, despite comparable PFS (p = .18-.89) and OS (p = .23-.30).
CONCLUSIONS: Nilotinib, dasatinib and flumatinib had comparable efficacy, and significantly higher therapy responses and higher FFS rates than imatinib in newly diagnosed CML patients. However, there were no significant differences in PFS and OS among these 4 TKIs. These real-world data may provide additional evidence for routine clinical assessments to identify more appropriate therapies.
摘要：
背景：全面比较尼洛替尼的治疗反应和结果的数据有限，达沙替尼,氟马替尼和伊马替尼在现实世界中用于新诊断的慢性期慢性粒细胞白血病。
方法：来自接受第二代酪氨酸激酶抑制剂（2G-TKI，尼洛替尼,对来自77个中国中心的达沙替尼或氟马替尼）或伊马替尼治疗进行了回顾性询问。进行倾向评分匹配(PSM)分析以比较这4种TKI中的治疗反应和结果。
结果：2,496名接受初始尼洛替尼的患者（n=512），达沙替尼（n=134），本研究对氟马替尼(n=411)或伊马替尼(n=1,439)治疗进行了回顾性调查.PSM分析表明，接受初始尼洛替尼的患者，达沙替尼或氟马替尼治疗具有相当的细胞遗传学和分子反应(p=.28-.91)和生存结局，包括无失败生存(FFS,p=.28-.43)，无进展生存期（PFS，p=.19-.93）和总生存期（OS）（p值=.76-.78），但细胞遗传学和分子反应的累积发生率（所有p值<.001）和FFS的概率（p<.001-.01）明显高于接受伊马替尼治疗的患者，尽管PFS（p=.18-.89）和OS（p=.23-.30）相当。
结论：尼洛替尼，达沙替尼和氟马替尼的疗效相当，新诊断的CML患者的治疗反应和FFS率明显高于伊马替尼。然而,这4种TKIs的PFS和OS无显著差异。这些真实世界的数据可以为常规临床评估提供额外的证据，以确定更合适的治疗方法。
方法：来自接受第二代酪氨酸激酶抑制剂（2G-TKI，尼洛替尼,对来自77个中国中心的达沙替尼或氟马替尼）或伊马替尼治疗进行了回顾性询问。进行倾向评分匹配(PSM)分析以比较这4种TKI中的治疗反应和结果。
结果：2,496名接受初始尼洛替尼的患者（n=512），达沙替尼（n=134），本研究对氟马替尼(n=411)或伊马替尼(n=1,439)治疗进行了回顾性调查.PSM分析表明，接受初始尼洛替尼的患者，达沙替尼或氟马替尼治疗具有相当的细胞遗传学和分子反应(p=.28-.91)和生存结局，包括无失败生存(FFS,p=.28-.43)，无进展生存期（PFS，p=.19-.93）和总生存期（OS）（p值=.76-.78），但细胞遗传学和分子反应的累积发生率（所有p值<.001）和FFS的概率（p<.001-.01）明显高于接受伊马替尼治疗的患者，尽管PFS（p=.18-.89）和OS（p=.23-.30）相当。
结论：尼洛替尼，达沙替尼和氟马替尼的疗效相当，新诊断的CML患者的治疗反应和FFS率明显高于伊马替尼。然而,这4种TKIs的PFS和OS无显著差异。这些真实世界的数据可以为常规临床评估提供额外的证据，以确定更合适的治疗方法。
