Burns Linda J, Logan Brent R, Chitphakdithai Pintip, Miller John P, Drexler Rebecca, Spellman Stephen, Switzer Galen E, Wingard John R, Anasetti Claudio, Confer Dennis L
National Marrow Donor Program/Be the Match, Minneapolis, Minnesota; Center for International Blood and Marrow Transplant Research, Minneapolis, Minnesota.
Center for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, Wisconsin.
Biol Blood Marrow Transplant. 2016 Jun;22(6):1108-1116. doi: 10.1016/j.bbmt.2016.02.018. Epub 2016 Mar 21.
We report a comparison of time to recovery, side effects, and change in blood counts from baseline to after donation from unrelated donors who participated in the Blood and Marrow Transplant Clinical Trials Network phase III randomized, multicenter trial (0201) in which donor-recipient pairs were randomized to either peripheral blood stem cell (PBSC) or bone marrow (BM) donation. Of the entire cohort, 262 donated PBSC and 264 donated BM; 372 (71%) donors were from domestic and 154 (29%) were from international centers (145 German and 9 Canadian). PBSC donors recovered in less time, with a median time to recovery of 1 week compared with 2.3 weeks for BM donors. The number of donors reporting full recovery was significantly greater for donors of PBSC than of BM at 1, 2, and 3 weeks and 3 months after donation. Multivariate analysis showed that PBSC donors were more likely to recover at any time after donation compared with BM donors (hazard ratio, 2.08; 95% confidence interval [CI], 1.73 to 2.50; P < .001). Other characteristics that significantly increased the likelihood of complete recovery were being an international donor and donation in more recent years. Donors of BM were more likely to report grades 2 to 4 skeletal pain, body symptoms, and fatigue at 1 week after donation. In logistic regression analysis of domestic donors only in which toxicities at peri-collection time points (day 5 filgrastim for PBSC donors and day 2 after collection of BM donors) could be analyzed, no variable was significantly associated with grades 2 to 4 skeletal pain, including product donated (BM versus PBSC; odds ratio, 1.13; 95% CI, .74 to 1.74; P = .556). Blood counts were affected by product donated, with greater mean change from baseline to after donation for white blood cells, neutrophils, mononuclear cells, and platelets in PBSC donors whereas BM donors experienced a greater mean change in hemoglobin. This analysis provided an enhanced understanding of donor events as product donated was independent of physician bias or donor preference.
我们报告了参与血液和骨髓移植临床试验网络III期随机多中心试验（0201）的无关供者从捐献前基线到捐献后恢复时间、副作用及血细胞计数变化的比较情况。在该试验中，供者 - 受者对被随机分配至外周血干细胞（PBSC）捐献组或骨髓（BM）捐献组。在整个队列中，262名供者捐献了PBSC，264名供者捐献了BM；372名（71%）供者来自国内，154名（29%）来自国际中心（145名来自德国，9名来自加拿大）。PBSC供者恢复时间更短，恢复的中位时间为1周，而BM供者为2.3周。在捐献后1周、2周、3周和3个月时，报告完全恢复的PBSC供者数量显著多于BM供者。多变量分析显示，与BM供者相比，PBSC供者在捐献后任何时间恢复的可能性更大（风险比，2.08；95%置信区间[CI]，1.73至2.50；P <.001）。其他显著增加完全恢复可能性的特征包括作为国际供者以及近年的捐献。BM供者在捐献后1周更有可能报告2至4级骨骼疼痛、身体症状和疲劳。仅对国内供者进行逻辑回归分析，在该分析中可以分析采集周边时间点（PBSC供者为第5天使用非格司亭，BM供者为采集后第2天）的毒性，没有变量与2至4级骨骼疼痛显著相关，包括所捐献的产品（BM与PBSC；比值比，1.13；95%CI，0.74至1.74；P = 0.556）。血细胞计数受所捐献产品的影响，PBSC供者从基线到捐献后的白细胞、中性粒细胞、单核细胞和血小板的平均变化更大，而BM供者的血红蛋白平均变化更大。该分析增进了对供者情况的理解，因为所捐献的产品独立于医生偏见或供者偏好。
