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.
