Reljic T, Kumar A, Djulbegovic B, Kharfan-Dabaja M A
Center for Comparative Effectiveness Research, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.
1] Center for Comparative Effectiveness Research, Morsani College of Medicine, University of South Florida, Tampa, FL, USA [2] Department of Oncologic Sciences, H. Lee Moffitt Cancer Center/University of South Florida, Morsani College of Medicine, Tampa, FL, USA.
Bone Marrow Transplant. 2015 Aug;50(8):1069-74. doi: 10.1038/bmt.2015.69. Epub 2015 Apr 13.
High-dose therapy (HDT) followed by autologous hematopoietic cell transplantation (auto-HCT) is offered to patients with chronic lymphocytic leukemia (CLL) both as front-line consolidation and in the relapsed setting. The role of HDT in the front-line consolidation setting in CLL is uncertain. Literature search of PUBMED and Cochrane until 14 November 2014 and the last 2 years of abstracts from relevant conferences was undertaken. End points included benefits (overall survival; OS, PFS, event-free survival; EFS) and harms (adverse events, secondary malignancies, treatment-related mortality). The search identified 495 references of which four studies met inclusion criteria. Altogether, 301 patients were randomized to the HDT/auto-HCT arm and 299 patients to the control arm. Offering front-line HDT/auto-HCT did not result in statistically significant improvement in OS (Hazard ratio (HR)=0.91; 95% confidence interval (CI)= 0.62, 1.33) or PFS (HR=0.70; 95% CI= 0.32, 1.52). There was a statistically significant advantage favoring HDT/auto-HCT for EFS (HR=0.46; 95% CI= 0.26, 0.83). Moreover, HDT/auto-HCT did not result in higher rate of secondary malignancy (risk ratio=1.06; 95% CI=0.55, 2.05) or treatment-related mortality (risk ratio=1.32; 95% CI= 0.43, 4.06). Offering HDT/auto-HCT as front-line consolidation in patients with CLL does not improve OS. At present this approach should not be offered outside the context of a clinical trial.
对于慢性淋巴细胞白血病（CLL）患者，高剂量疗法（HDT）后进行自体造血细胞移植（auto-HCT）可作为一线巩固治疗以及复发情况下的治疗方案。HDT在CLL一线巩固治疗中的作用尚不确定。我们检索了截至2014年11月14日的PUBMED和Cochrane数据库以及相关会议最近两年的摘要。终点指标包括获益（总生存期；OS、无进展生存期；PFS、无事件生存期；EFS）和危害（不良事件、继发性恶性肿瘤、治疗相关死亡率）。检索共识别出495篇参考文献，其中四项研究符合纳入标准。总共301例患者被随机分配至HDT/auto-HCT组，299例患者被分配至对照组。提供一线HDT/auto-HCT并未使OS（风险比（HR）=0.91；95%置信区间（CI）=0.62，1.33）或PFS（HR=0.70；95%CI=0.32，1.52）有统计学意义的改善。对于EFS，HDT/auto-HCT有统计学意义的优势（HR=0.46；95%CI=0.26，0.83）。此外，HDT/auto-HCT并未导致继发性恶性肿瘤发生率更高（风险比=1.06；95%CI=0.55，2.05）或治疗相关死亡率更高（风险比=1.32；95%CI=0.43，4.06）。在CLL患者中提供HDT/auto-HCT作为一线巩固治疗并不能改善OS。目前，在临床试验背景之外不应采用这种方法。
