Peripheral-Blood Stem Cells versus Bone Marrow from Unrelated Donors

被引:652
作者
Anasetti, Claudio [1 ]
Logan, Brent R. [2 ]
Lee, Stephanie J. [3 ]
Waller, Edmund K. [4 ]
Weisdorf, Daniel J. [5 ]
Wingard, John R. [23 ]
Cutler, Corey S. [8 ]
Westervelt, Peter [9 ]
Woolfrey, Ann [3 ]
Couban, Stephen [10 ]
Ehninger, Gerhard [12 ]
Johnston, Laura [13 ]
Maziarz, Richard T. [14 ]
Pulsipher, Michael A. [15 ]
Porter, David L. [16 ]
Mineishi, Shin [17 ]
McCarty, John M. [18 ]
Khan, Shakila P. [6 ]
Anderlini, Paolo [19 ]
Bensinger, William I. [3 ]
Leitman, Susan F. [20 ]
Rowley, Scott D. [22 ]
Bredeson, Christopher [11 ]
Carter, Shelly L. [21 ]
Horowitz, Mary M. [2 ]
Confer, Dennis L. [7 ]
机构
[1] Univ S Florida, Coll Med, H Lee Moffitt Canc Ctr & Res Inst, Tampa, FL 33612 USA
[2] Med Coll Wisconsin, Milwaukee, WI 53226 USA
[3] Fred Hutchinson Canc Res Ctr, Seattle, WA 98104 USA
[4] Emory Univ, Winship Canc Inst, Atlanta, GA 30322 USA
[5] Univ Minnesota, Med Ctr, Minneapolis, MN 55455 USA
[6] Mayo Clin, Rochester, MN USA
[7] Natl Marrow Donor Program, Minneapolis, MN USA
[8] Dana Farber Canc Inst, Boston, MA 02115 USA
[9] Washington Univ, Siteman Canc Ctr, St Louis, MO USA
[10] Dalhousie Univ, Halifax, NS, Canada
[11] Ottawa Hosp, Ottawa, ON, Canada
[12] Univ Hosp Dresden, Dresden, Germany
[13] Stanford Univ, Med Ctr, Stanford, CA 94305 USA
[14] Oregon Hlth & Sci Univ, Portland, OR 97201 USA
[15] Univ Utah, Primary Childrens Med Ctr, Salt Lake City, UT USA
[16] Univ Penn, Philadelphia, PA 19104 USA
[17] Univ Michigan, Ann Arbor, MI 48109 USA
[18] Virginia Commonwealth Univ, Massey Canc Ctr, Richmond, VA 23284 USA
[19] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA
[20] NIH, Bethesda, MD 20892 USA
[21] EMMES Corp, Rockville, MD USA
[22] Hackensack Univ, John Theurer Canc Ctr, Hackensack, NJ USA
[23] Univ Florida, Shands Canc Ctr, Gainesville, FL USA
关键词
VERSUS-HOST-DISEASE; COLONY-STIMULATING FACTOR; TERM-FOLLOW-UP; RANDOMIZED-TRIAL; CHRONIC GRAFT; PROGENITOR CELLS; ALLOGENEIC TRANSPLANTATION; LEUKEMIA; RECIPIENTS; MALIGNANCIES;
D O I
10.1056/NEJMoa1203517
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND Randomized trials have shown that the transplantation of filgrastim-mobilized peripheral-blood stem cells from HLA-identical siblings accelerates engraftment but increases the risks of acute and chronic graft-versus-host disease (GVHD), as compared with the transplantation of bone marrow. Some studies have also shown that peripheral-blood stem cells are associated with a decreased rate of relapse and improved survival among recipients with high-risk leukemia. METHODS We conducted a phase 3, multicenter, randomized trial of transplantation of peripheral-blood stem cells versus bone marrow from unrelated donors to compare 2-year survival probabilities with the use of an intention-to-treat analysis. Between March 2004 and September 2009, we enrolled 551 patients at 48 centers. Patients were randomly assigned in a 1: 1 ratio to peripheral-blood stem-cell or bone marrow transplantation, stratified according to transplantation center and disease risk. The median follow-up of surviving patients was 36 months (interquartile range, 30 to 37). RESULTS The overall survival rate at 2 years in the peripheral-blood group was 51% (95% confidence interval [CI], 45 to 57), as compared with 46% (95% CI, 40 to 52) in the bone marrow group (P = 0.29), with an absolute difference of 5 percentage points (95% CI, -3 to 14). The overall incidence of graft failure in the peripheral-blood group was 3% (95% CI, 1 to 5), versus 9% (95% CI, 6 to 13) in the bone marrow group (P = 0.002). The incidence of chronic GVHD at 2 years in the peripheral-blood group was 53% (95% CI, 45 to 61), as compared with 41% (95% CI, 34 to 48) in the bone marrow group (P = 0.01). There were no significant between-group differences in the incidence of acute GVHD or relapse. CONCLUSIONS We did not detect significant survival differences between peripheral-blood stem-cell and bone marrow transplantation from unrelated donors. Exploratory analyses of secondary end points indicated that peripheral-blood stem cells may reduce the risk of graft failure, whereas bone marrow may reduce the risk of chronic GVHD. (Funded by the National Heart, Lung, and Blood Institute-National Cancer Institute and others; ClinicalTrials.gov number, NCT00075816.)
引用
收藏
页码:1487 / 1496
页数:10
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