Wang H F, Zhang Y L, Liu X L, Zhu H L, Liang R, Liu B C, Zhou L, Meng L, Li W M, Jiang Q
Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing 100044, China.
Department of Hematology, Affiliated Cancer Hospital of Zhengzhou University, Henan Provincial Tumor Hospital, Zhengzhou 450008, China.
Zhonghua Xue Ye Xue Za Zhi. 2021 Jul 14;42(7):535-542. doi: 10.3760/cma.j.issn.0253-2727.2021.07.002.
To investigate the current status of treatment choice and responses in patients with chronic myeloid leukemia (CML) in China. From the end of April to mid-May in 2020, a cross-sectional survey, by filling out a survey questionnaire, was conducted to explore the first-line choice of tyrosine kinase inhibitors (TKI) , current medications, drug switch and major molecular responses (MMR) as well as the variables associated with them in patients in China. Data of 2933 respondents with CML from 31 provinces, municipalities, and autonomous regions across the country were included in this study. 1683 respondents (57.4%) were males. Median age was 38 (16-87) years old. 2481 respondents (84.6%) received imatinib as first-line TKI; 1803 (61.5%) , the original new drug (branded drug) . When completing the questionnaire, 1765 respondents (60.2%) were receiving imatinib; 1791 (61.1%) , branded drug. 1185 respondents (40.4%) had experienced TKI switch. With a median follow-up of 45 (3-227) months, 1417 of 1944 (72.9%) respondents with newly diagnosed CML in the chronic phase achieved MMR. Multivariate analysis showed that the respondents with urban household registration (=0.6, 95% 0.5-0.8, <0.001) , ≥ bachelor degree (=0.5, 95% 0.4-0.7, <0.001) , and in the advanced phase at diagnosis (=0.5, 95% 0.3-0.8, =0.001) less preferred Chinese generic TKI, while the respondents from the central region in China more preferred Chinese generic TKI more than those from the eastern region (=1.7, 95% 1.4-2.0, <0.001) . Moreover, the respondents in the advanced phase at diagnosis more preferred second-generation TKI (=5.4, 95% 3.6-8.2, <0.001) ; those ≥60 years old, less preferred second-generation TKI (=0.4, 95% 0.2-0.7, =0.002) . Being in the advanced phase at diagnosis (=2.2, 95% 1.6-3.2, <0.001) , first-line choice of imatinib (=2.0, 95% 1.6-2.6, <0.001) or Chinese generic drugs (=1.3, 95% 1.1-1.6, =0.002) , longer interval from diagnose of CML to starting TKI treatment (=1.2, 95% 1.1-1.2, <0.001) and longer duration of TKI therapy (=1.1, 95% 1.0-1.1, <0.001) were significantly associated with TKI switch; urban household registration (=0.7, 95% 0.6-0.8, <0.001) , ≥MMR (=0.6, 95% 0.5-0.8, <0.001) and unknown response (=0.7, 95% 0.6-0.9, =0.003) , no TKI switch. Female sex (=1.4, 95% 1.1-1.7, =0.003) , urban household registration (=1.6, 95% 1.3-2.0, <0.001) , front-line imatinib therapy (=1.4, 95% 1.1-1.9, =0.016) and longer duration of TKI treatment (=1.2, 95% 1.2-1.3, <0.001) were significantly associated with achieving a MMR or better response; age ≥ 60 years old (=0.7, 95% 0.4-1.0, =0.047) and TKI switch (=0.6, 95% 0.5-0.7, <0.001) , achieving no MMR. By 2020, the majority of Chinese CML patients received imatinib as the fist-line TKI therapy and continue to take it. More than half of TKIs were branded drugs. Socio-demographic characteristics and clinical variables affect their TKI choice, drug switch, and treatment response.
调查中国慢性髓性白血病(CML)患者的治疗选择及反应现状。2020年4月底至5月中旬,通过填写调查问卷进行横断面调查,以探究中国患者酪氨酸激酶抑制剂(TKI)的一线选择、当前用药、换药情况及主要分子反应(MMR),以及与之相关的变量。本研究纳入了来自全国31个省、直辖市和自治区的2933例CML受访者的数据。1683例受访者(57.4%)为男性。中位年龄为38(16 - 87)岁。2481例受访者(84.6%)接受伊马替尼作为一线TKI治疗;1803例(61.5%)使用原研新药(品牌药)。在完成调查问卷时,1765例受访者(60.2%)正在接受伊马替尼治疗;1791例(61.1%)使用品牌药。1185例受访者(40.4%)经历过TKI换药。中位随访时间为45(3 - 227)个月,1944例新诊断为慢性期CML的受访者中,1417例(72.9%)达到MMR。多因素分析显示,具有城市户口的受访者(=0.6,95%置信区间0.5 - 0.8,<0.001)、≥本科学历的受访者(=0.5,95%置信区间0.4 - 0.7,<0.001)以及诊断时处于晚期的受访者(=0.5,95%置信区间0.3 - 0.8,=0.001)较少选择国产仿制药,而中国中部地区的受访者比东部地区的受访者更倾向于选择国产仿制药(=1.7,95%置信区间1.4 - 2.0,<0.001)。此外,诊断时处于晚期的受访者更倾向于选择第二代TKI(=5.4,95%置信区间3.6 - 8.2,<0.001);≥60岁的受访者较少选择第二代TKI(=0.4,95%置信区间0.2 - 0.7,=0.002)。诊断时处于晚期(=2.2,95%置信区间1.6 - 3.2,<0.001)、一线选择伊马替尼(=2.0,95%置信区间1.6 - 2.6,<0.001)或国产仿制药(=1.3,95%置信区间1.1 - 1.6,=0.002)、CML诊断至开始TKI治疗的间隔时间较长(=1.2,95%置信区间1.1 - 1.2,<0.001)以及TKI治疗持续时间较长(=1.1,95%置信区间1.0 - 1.1,<0.001)与TKI换药显著相关;具有城市户口(=0.7,95%置信区间0.6 - 0.8,<0.001)、≥MMR(=0.6,95%置信区间0.5 - 0.8,<0.001)以及反应未知(=0.7,95%置信区间0.6 - 0.9,=0.003)的受访者未进行TKI换药。女性(=1.4,95%置信区间1.1 - 1.7,=0.003)、具有城市户口(=1.6,95%置信区间1.3 - 2.0,<0.001)、一线伊马替尼治疗(=1.4,95%置信区间1.1 - 1.9,=0.016)以及TKI治疗持续时间较长(=1.2,95%置信区间1.2 - 1.3,<0.001)与达到MMR或更好反应显著相关;年龄≥60岁(=0.7,95%置信区间0.4 - 1.0,=0.047)以及TKI换药(=0.6,95%置信区间0.5 - 0.7,<0.001)的受访者未达到MMR。到2020年,大多数中国CML患者接受伊马替尼作为一线TKI治疗并持续使用。超过一半的TKI为品牌药。社会人口学特征和临床变量影响他们的TKI选择、换药情况及治疗反应。