氟马替尼联合多药化疗治疗费城染色体阳性急性淋巴细胞白血病的疗效和安全性分析

Efficacy and safety of flumatinib combined with multi-agent chemotherapy in treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia

目的:评价氟马替尼联合多药化疗在费城染色体阳性急性淋巴细胞白血病(Philadelphia chromosome-positive acute lymphoblastic leukemia,Ph^(+)ALL)患者中的疗效和安全性。方法:回顾性分析南昌大学第一附属医院2019年12月至2022年2月收治的25例行氟马替尼联合CALLG-2008化疗方案治疗的成人Ph^(+)ALL患者的临床资料,分析其疗效和安全性。结果:25例患者中,21例(84%)患者于初次诱导期联合氟马替尼,4例(16%)患者于第1个疗程诱导结束后联合氟马替尼。患者化疗28天、3个月和6个月的完全缓解(complete response,CR)率分别为88%、91.67%和90.48%;主要分子学反应(major molecular response,MMR)率分别为68%、79.17%和80.95%;完全分子学反应(complete molecular response,CMR)率分别为60%、75%和80.95%。中位随访时间180(75.6~458.1)天,随访时总生存(overall survival,OS)率为82.61%,无复发生存(recurrence-free survival,RFS)率为73.91%。氟马替尼用药过程中,有22例(88%)患者出现Ⅳ度骨髓抑制,非血液学不良反应主要有腹泻、转氨酶升高、疲乏、恶心等,经对症治疗后均可好转。结论:氟马替尼联合多药化疗治疗Ph^(+)ALL患者安全有效。

Objective:To evaluate the efficacy and safety of flumatinib combined with multi-agent chemotherapy in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia(Ph^(+)ALL).Methods:The retrospective analysis involved 25 patients with Ph^(+)ALL treated with flumatinib combined with CALLG-2008 chemotherapy at The First Affiliated Hospital of Nanchang University from December2019 to February 2022.The efficacy and safety of the treatment were statistically analyzed.Results:Among the 25 patients,21(84%)and 4(16%)patients were treated with flumatinib during and after the first induction period,respectively.Complete response(CR)rates at 28days,3 months,and 6 months were 88%,91.67%,and 90.48%,respectively.The respective major molecular response(MMR)rates were68%,79.17%,and 80.95%.The respective complete molecular response(CMR)rates were 60%,75%,and 80.95%.The patients were followed-up with a median follow-up time of 180 days(range,75.6-458.1 days).The overall survival(OS)and recurrence-free survival(RFS)rates were 82.61%and 73.91%,respectively.During flumatinib treatment,22(88%)patients displayed gradeⅣmyelosuppression.The nonhematologic adverse events mainly included diarrhea,elevated transaminase,fatigue,and nausea.All adverse events improved after treatment.Conclusions:Flumatinib combined with multi-agent chemotherapy is safe and effective in the treatment of patients with Ph^(+)ALL.