Stephens Sarah J, Thomas Samantha, Rizzieri David A, Horwitz Mitchell E, Chao Nelson J, Engemann Ashley M, Lassiter Martha, Kelsey Chris R
Department of Radiation Oncology, Duke University Medical Center, Durham, North Carolina.
Department of Biostatistics and Bioinformatics, Department of Medicine, Duke University Medical Center, Durham, North Carolina.
Adv Radiat Oncol. 2016 Jul 15;1(4):272-280. doi: 10.1016/j.adro.2016.07.001. eCollection 2016 Oct-Dec.
The purpose of this study was to compare leukemia-free survival (LFS) and other clinical outcomes in patients with acute myelogenous leukemia who underwent a myeloablative allogeneic stem cell transplant with and without total body irradiation (TBI).
Adult patients with acute myelogenous leukemia undergoing myeloablative allogeneic stem cell transplant at Duke University Medical Center between 1995 and 2012 were included. The primary endpoint was LFS. Secondary outcomes included overall survival (OS), nonrelapse mortality, and the risk of pulmonary toxicity. Kaplan-Meier survival estimates and Cox proportional hazards multivariate analyses were performed.
A total of 206 patients were evaluated: 90 received TBI-based conditioning regimens and 116 received chemotherapy alone. Median follow-up was 36 months. For all patients, 2-year LFS and OS were 36% (95% confidence interval [CI], 29-43) and 39% (95% CI, 32-46), respectively. After adjusting for known prognostic factors using a multivariate analysis, TBI was associated with improved LFS (hazard ratio: 0.63; 95% CI: 0.44-0.91) and OS (hazard ratio: 0.63; 95% CI, 0.43-0.91). There was no difference in nonrelapse mortality between cohorts, but pulmonary toxicity was significantly more common with TBI (2-year incidence 42% vs 12%, < .001). High-grade pulmonary toxicity predominated with both conditioning strategies (70% and 93% of cases were grade 3-5 with TBI and chemotherapy alone, respectively).
TBI-based regimens were associated with superior LFS and OS but at the cost of increased pulmonary toxicity.
本研究旨在比较接受清髓性异基因干细胞移植且接受或未接受全身照射(TBI)的急性髓性白血病患者的无白血病生存期(LFS)及其他临床结局。
纳入1995年至2012年间在杜克大学医学中心接受清髓性异基因干细胞移植的成年急性髓性白血病患者。主要终点为LFS。次要结局包括总生存期(OS)、非复发死亡率及肺部毒性风险。进行了Kaplan-Meier生存估计和Cox比例风险多变量分析。
共评估了206例患者:90例接受了基于TBI的预处理方案,116例仅接受了化疗。中位随访时间为36个月。所有患者的2年LFS和OS分别为36%(95%置信区间[CI],29 - 43)和39%(95%CI,32 - 46)。在使用多变量分析调整已知预后因素后,TBI与改善的LFS(风险比:0.63;95%CI:0.44 - 0.91)和OS(风险比:0.63;95%CI,0.43 - 0.91)相关。队列间非复发死亡率无差异,但TBI导致的肺部毒性明显更常见(2年发生率42%对12%,<0.001)。两种预处理策略中高级别肺部毒性均占主导(TBI和单纯化疗的病例分别有70%和93%为3 - 5级)。
基于TBI的方案与更好的LFS和OS相关,但代价是肺部毒性增加。