We herein report the results of the New TARGET study 2nd-line, which collected data on patients with chronic-phase (CP) chronic myeloid leukemia (CML) who received a 2nd-line tyrosine kinase inhibitor (TKI) because of resistance and/or to a 1st-line TKI. A total of 98 patients were enrolled intolerance between April 2010 and March 2013, and 82 patients were analyzed. The median age was 54 years (range 22-88 years). Seventy-six patients (93%) received imatinib as the 1st-line TKI. Forty-five (55%) and 37 (45%) patients began nilotinib and dasatinib treatments at entry, respectively. First-line TKI treatment achieved complete hematological response in 79 patients (96%) and complete cytogenetic response (CCyR) in 49 patients (60%), respectively. Nine patients (11%) had BCR-ABL1 kinase domain point mutations at enrollment. The estimated 3-year progression-free-survival rate after enrollment was 98.7% (95% CI 91.1-99.8%). Overall, the probabilities of achieving CCyR and a major molecular response were 89.3% (95% CI 81.4-94.8%) and 87.2% (95% CI 78.1-93.8%), respectively. There were no new safety issues. This study demonstrated that CML-CP patients in Japan who are resistant and/or intolerant to a 1st-line TKI can achieve an extremely good outcome by 2nd-line TKI treatment.

中文翻译：

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在日本对一线酪氨酸激酶抑制剂具有耐药性和/或不耐受性的慢性慢性粒细胞白血病的治疗结果：New TARGET研究二线研究的结果。

我们在此报告了新的TARGET研究二线研究的结果，该研究收集了由于抗药性和/或/或接受二线酪氨酸激酶抑制剂（TKI）的慢性期（CP）慢性粒细胞白血病（CML）患者的数据到一线TKI。在2010年4月至2013年3月之间，共招募了98例不耐症患者，并对82例患者进行了分析。中位年龄为54岁（范围为22-88岁）。76例患者（93％）接受伊马替尼作为一线TKI。四十五（55％）和37（45％）的患者在入院时分别开始尼罗替尼和达沙替尼治疗。一线TKI治疗分别实现了79例患者（96％）的完全血液学应答和49例患者（60％）的完全细胞遗传学应答（CCyR）。入组时有9名患者（11％）具有BCR-ABL1激酶结构域点突变。入组后3年无进展生存率估计为98.7％（95％CI 91.1-99.8％）。总体而言，实现CCyR和主要分子应答的概率分别为89.3％（95％CI 81.4-94.8％）和87.2％（95％CI 78.1-93.8％）。没有新的安全问题。这项研究表明，在日本，对一线TKI耐药和/或不耐受的CML-CP患者可以通过二线TKI治疗获得非常好的结果。