2020年中国慢性髓性白血病患者酪氨酸激酶抑制剂治疗状况调研

OBJECTIVE: To investigate the current status of treatment choice and responses in patients with chronic myeloid leukemia (CML) in China. METHODS: 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. RESULTS: 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（OR＝0.6, 95％CI 0.5–0.8, P<0.001）, ≥ bachelor degree（OR＝0.5, 95％CI 0.4–0.7, P<0.001）, and in the advanced phase at diagnosis（OR＝0.5, 95％CI 0.3–0.8, P＝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（OR＝1.7, 95％CI 1.4–2.0, P<0.001）. Moreover, the respondents in the advanced phase at diagnosis more preferred second-generation TKI（OR＝5.4, 95％CI 3.6–8.2, P<0.001）; those ≥60 years old, less preferred second-generation TKI（OR＝0.4, 95％CI 0.2–0.7, P＝0.002）. Being in the advanced phase at diagnosis（OR＝2.2, 95％CI 1.6–3.2, P<0.001）, first-line choice of imatinib（OR＝2.0, 95％CI 1.6–2.6, P<0.001）or Chinese generic drugs（OR＝1.3, 95％CI 1.1–1.6, P＝0.002）, longer interval from diagnose of CML to starting TKI treatment（OR＝1.2, 95％CI 1.1–1.2, P<0.001）and longer duration of TKI therapy（OR＝1.1, 95％ CI 1.0–1.1, P<0.001）were significantly associated with TKI switch; urban household registration（OR＝0.7, 95％CI 0.6–0.8, P<0.001）, ≥MMR（OR＝0.6, 95％CI 0.5–0.8, P<0.001）and unknown response（OR＝0.7, 95％CI 0.6–0.9, P＝0.003）, no TKI switch. Female sex（OR＝1.4, 95％CI 1.1–1.7, P＝0.003）, urban household registration（OR＝1.6, 95％CI 1.3–2.0, P<0.001）, front-line imatinib therapy（OR＝1.4, 95％ CI 1.1–1.9, P＝0.016）and longer duration of TKI treatment（OR＝1.2, 95％CI 1.2–1.3, P<0.001）were significantly associated with achieving a MMR or better response; age ≥ 60 years old（OR＝0.7, 95％CI 0.4–1.0, P＝0.047）and TKI switch（OR＝0.6, 95％ CI 0.5–0.7, P<0.001）, achieving no MMR. CONCLUSION: 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.