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异基因外周血干细胞与骨髓移植治疗血液系统恶性肿瘤的比较:九项随机试验的个体患者数据荟萃分析

Allogeneic peripheral blood stem-cell compared with bone marrow transplantation in the management of hematologic malignancies: an individual patient data meta-analysis of nine randomized trials.

出版信息

J Clin Oncol. 2005 Aug 1;23(22):5074-87. doi: 10.1200/JCO.2005.09.020.

DOI:10.1200/JCO.2005.09.020
PMID:16051954
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1475795/
Abstract

PURPOSE

Considerable uncertainty exists regarding relative effects of allogeneic peripheral blood stem cells transplantation (PBSCT) versus bone marrow transplantation (BMT) on outcomes of patients with hematologic malignancies.

PATIENTS AND METHODS

To provide the totality of research evidence related to the effects of PBSCT versus BMT, we conducted an individual-patient data meta-analysis using data from nine randomized trials enrolling 1,111 adult patients.

RESULTS

Compared with BMT, PBSCT led to faster neutrophil (odds ratio [OR] = 0.31; 95% CI, 0.25 to 0.38; P < .00001) and platelet engraftment (OR = 0.52; 95% CI, 0.44 to 0.61; P < .00001). PBSCT was associated with a significant increase in the development of grade 3-4 acute graft-versus-host disease (GVHD; OR = 1.39; 95% CI, 1.03 to 1.88) and extensive (47% v 31% at 3 years; OR = 1.89; 95% CI, 1.47 to 2.42; P < .000001) and overall chronic GVHD (68% v 52% at 3 years; OR = 1.92; 95% CI, 1.47 to 2.49; P < .000001), but not grade 2-4 acute GVHD (54% v 53%; P = .49). PBSCT was associated with a decrease in relapse (21% v 27% at 3 years; OR = 0.71; 95% CI, 0.54 to 0.93; P = .01) in both late-stage-(33% v 51% at 3 years; OR = 0.59; 95% CI, 0.38 to 0.93; P = .02) and early-stage-disease patients (16% v 20% at 3 years; OR = 0.69; 95% CI, 0.49 to 0.98; P = .04). Nonrelapse mortality was not different between groups. Overall and disease-free survival were only statistically significantly improved in patients with late-stage disease (overall survival: 46% v 31% at 3 years; OR = 0.64; 95% CI, 0.46 to 0.90; P = .01; disease-free survival: 41% v 27% at 3 years; OR = 0.63 95% CI, 0.45 to 0.87; P = .01).

CONCLUSION

PBSCT is associated with a decreased relapse rate in hematologic malignancies and improvement in overall and disease-free survival in patients with late-stage disease. PBSCT is also associated with a significant risk of extensive chronic GVHD.

摘要

目的

关于异基因外周血干细胞移植(PBSCT)与骨髓移植(BMT)对血液系统恶性肿瘤患者预后的相对影响,存在相当大的不确定性。

患者与方法

为了提供与PBSCT和BMT效果相关的全部研究证据,我们使用来自9项随机试验的数据进行了一项个体患者数据荟萃分析,这些试验纳入了1111例成年患者。

结果

与BMT相比,PBSCT导致中性粒细胞(优势比[OR]=0.31;95%置信区间,0.25至0.38;P<.00001)和血小板植入更快(OR=0.52;95%置信区间,0.44至0.61;P<.00001)。PBSCT与3-4级急性移植物抗宿主病(GVHD)(OR=1.39;95%置信区间,1.03至1.88)以及广泛慢性GVHD(3年时为47%对31%;OR=1.89;95%置信区间,1.47至2.42;P<.000001)和总体慢性GVHD(3年时为68%对52%;OR=1.92;95%置信区间,1.47至2.49;P<.000001)的发生率显著增加相关,但与2-4级急性GVHD(54%对53%;P=.49)无关。PBSCT与晚期疾病患者(3年时为33%对51%;OR=0.59;95%置信区间,0.38至0.93;P=.02)和早期疾病患者(3年时为16%对20%;OR=0.69;95%置信区间,0.49至0.98;P=.04)的复发率降低相关(3年时为21%对27%;OR=0.71;95%置信区间,0.54至0.93;P=.01)。两组间非复发死亡率无差异。仅晚期疾病患者的总生存和无病生存在统计学上有显著改善(总生存:3年时为46%对31%;OR=0.64;95%置信区间,0.46至0.90;P=.01;无病生存:3年时为41%对27%;OR=0.63,95%置信区间,0.45至0.87;P=.01)。

结论

PBSCT与血液系统恶性肿瘤的复发率降低以及晚期疾病患者的总生存和无病生存改善相关。PBSCT也与广泛慢性GVHD的显著风险相关。

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