|Title||Peripheral-blood stem cells versus bone marrow from unrelated donors.|
|Publication Type||Journal Article|
|Year of Publication||2012|
|Authors||Anasetti, C, Logan, BR, Lee, SJ, Waller, EK, Weisdorf, DJ, Wingard, JR, Cutler, CS, Westervelt, P, Woolfrey, A, Couban, S, Ehninger, G, Johnston, L, Maziarz, RT, Pulsipher, MA, Porter, DL, Mineishi, S, McCarty, JM, Khan, SP, Anderlini, P, Bensinger, WI, Leitman, SF, Rowley, SD, Bredeson, C, Carter, SL, Horowitz, MM, Confer, DL|
|Corporate Authors||Blood and Marrow Transplant Clinical Trials Network|
|Journal||N Engl J Med|
|Date Published||2012 Oct 18|
|Keywords||Adult, Bone Marrow Diseases, Bone Marrow Transplantation, Cause of Death, Female, Graft Rejection, Graft vs Host Disease, Histocompatibility Testing, Humans, Intention to Treat Analysis, Kaplan-Meier Estimate, Leukemia, Male, Peripheral Blood Stem Cell Transplantation, Proportional Hazards Models, Recurrence, Survival Rate, Unrelated Donors|
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.).
|Alternate Journal||N Engl J Med|
|PubMed Central ID||PMC3816375|
|Grant List||U10 HL069294 / HL / NHLBI NIH HHS / United States |
P30 CA016672 / CA / NCI NIH HHS / United States
UG1 HL069286 / HL / NHLBI NIH HHS / United States
U10 HL069254 / HL / NHLBI NIH HHS / United States
U10 HL069290 / HL / NHLBI NIH HHS / United States
U10 HL069301 / HL / NHLBI NIH HHS / United States
U10 HL069330 / HL / NHLBI NIH HHS / United States
U10HL069294 / HL / NHLBI NIH HHS / United States
U10 HL069348 / HL / NHLBI NIH HHS / United States
U24 CA076518 / CA / NCI NIH HHS / United States
U10 HL069286 / HL / NHLBI NIH HHS / United States
U10 HL069249 / HL / NHLBI NIH HHS / United States
U10 HL069334 / HL / NHLBI NIH HHS / United States