为了减少化疗相关的毒性,无化疗方案成为Ph+ALL治疗的新趋势。因此,我们进行了达沙替尼联合泼尼松的2期试验,作为诱导(课程I)和早期巩固(课程II和III)治疗新诊断的Ph+ALL。该审判已在www上注册。chictr.org.cn,ChiCTR2000038053。从15家医院招募了41名患者。完全缓解(CR)为95%(39/41),包括两名老年人引产死亡。课程III结束时,25.6%(10/39)的患者达到完全分子应答。中位随访时间为15.4个月,在CR1时接受造血干细胞移植(HSCT)和仅接受化疗的患者的2年无病生存率(DFS)分别为100%和33%。当HSCT审查时,年轻和老年患者的2年DFS分别为51%和45%(p=0.987)。2年总生存率为45%,没有HSCT的患者为86%和100%,分别在复发后接受HSCT和在CR1接受HSCT。共有12例患者骨髓复发,1例中枢神经系统复发,38%发生在早期(在课程I和III之间)。IKZF1基因缺失显示与复发相关(p=0.019)。这种无化疗诱导和早期巩固方案在从头Ph+ALL中有效且耐受性良好。同种异体HSCT在无化学诱导后赋予了明确的生存优势。
To reducing chemotherapy-related toxicity, the chemo-free regimens become a new trend of Ph + ALL treatment. Therefore, we conducted a phase 2
trial of dasatinib plus prednisone, as induction (Course I) and early consolidation (Courses II and III) treating newly diagnosed Ph + ALL. The
trial was registered at www.chictr.org.cn, ChiCTR2000038053. Forty-one patients were enrolled from 15 hospitals. The complete remission (CR) was 95% (39/41), including two elderly induction deaths. By the end of Course III, 25.6% (10/39) of patients achieved a complete molecular response. With a median follow-up of 15.4 months, 2-year disease-free survival (DFS) were 100% and 33% for patients who receiving haematopoietic stem cell transplantation (HSCT) at CR1 and receiving chemotherapy alone respectively. When censored at time of HSCT, 2-year DFS were 51% and 45% for young and elderly patients (p = 0.987). 2-year overall survival were 45%, 86% and 100% for patients without HSCT, receiving HSCT after relapse and receiving HSCT at CR1 respectively. A total of 12 patients had marrow recurrences and one had CNS relapse, with 38% occurred early (between Courses I and III). IKZF1 gene deletion was shown to be associated with relapse (p = 0.019). This chemo-free induction and early consolidation regimen was efficacious and well-tolerated in de novo Ph + ALL. Allogeneic HSCT conferred definite survival advantage after chemo-free induction.