Objective: To investigate the efficacy and side effects of the consecutive chemotherapeutic protocol, Tongji-96, for adult patients with Philadelphia chromosome negative acute lymphoblastic leukemia (Ph-aALL).
Methods: A retrospective analysis was conducted on 95 cases of Ph-aALL patients treated between January 2004 and December 2012 with Tongji-96 regimen in Tongji hospital, Shanghai.
Results: Among these 95 patients, the overall complete remission (CR) rate was 92.6%, 7-year overall survival (OS) and event-free survival (EFS) rates were (39.3±5.9)% and (31.5±5.3)%, respectively, with the median survival of 28 months. Based on multivariable COX proportional hazards regression model analysis, patients with the poor karyotype and failed to achieve CR after first course induction therapy had a higher risk of mortality compared to those who had good or normal cytogenetics and achieved CR after 1 course of induction treatment [the risk ratios (RR) were 3.380 (95% CI 1.530-7.463, P=0.003) and 3.005 (95% CI 1.522-5.933, P=0.002)，respectively]. By means of Kaplan-Meier analysis and Log-rank test，patients aged less than 60 years and successively achieved CR after first induction therapy had more favorable 7-year OS and EFS rates. Patients with normal karyotype and hyperdiploidy had significantly higher 2-year OS and EFS rates compared with those with complex karyotype, t(4;11) translocation and other karyotypes.
Conclusion: Age (60 years as the cut-off)，treatment courses for achieving CR and cytogenetics were predictive factors for the prognosis of Ph-aALL from this retrospective study. As a comprehensive and sequential therapy protocol, Tongji-96 regimen was proved to obtain long-term survival, reduce risks for relapse and improve outcomes for part Ph-aALL patients.
目的: 探讨Ph染色体阴性成人急性淋巴细胞白血病（Ph−aALL）的系统序贯治疗方案（同济96方案）的疗效。
方法: 回顾性分析2004年1月至2012年12月收治的95例初治Ph−aALL患者的临床资料，并随访生存期。
结果: 95例Ph−aALL患者总的完全缓解（CR）率为92.6%，7年总体生存(OS）率为（39.3±5.9)%，7年无事件生存（EFS）率为（31.5±5.3) %，中位生存期28个月；多因素COX比例风险回归模型分析，预后差核型组患者的死亡风险是预后良好组的3.380倍（95%CI 1.530~7.463，P=0.003)，≥2个疗程获得CR者是单疗程获得CR者的3.005倍（95%CI 1.522~5.933，P=0.002)；Kaplan-Meier法及Log-rank检验分析，<60岁患者的7年OS率和EFS率明显高于≥60岁患者；单疗程获得CR者的7年OS率和EFS率明显高于≥2个疗程获得CR者；正常核型组和超二倍体核型组患者的2年OS率和EFS率明显高于复杂核型组、t(4; 11)组和其他核型组。
结论: 年龄（60岁为界点）、获得CR的疗程数和细胞遗传学成为影响Ph−aALL患者生存的相关因素。同济96方案系统序贯治疗Ph−aALL, CR率达到发达国家水平，远期疗效令人满意，可以实现部分Ph−aALL患者的长期生存，减少其复发，改善预后。