Peripheral-blood stem cells versus bone marrow from unrelated donors

Claudio Anasetti, Brent R. Logan, Stephanie J. Lee, Edmund K. Waller, Daniel J. Weisdorf, John R. Wingard, Corey S. Cutler, Peter Westervelt, Ann Woolfrey, Stephen Couban, Gerhard Ehninger, Laura Johnston, Richard T. Maziarz, Michael A. Pulsipher, David L. Porter, Shin Mineishi, John M. McCarty, Shakila P. Khan, Paolo Anderlini, William I. BensingerSusan F. Leitman, Scott D. Rowley, Christopher Bredeson, Shelly L. Carter, Mary M. Horowitz, Dennis L. Confer

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Abstract

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.)

Original languageEnglish (US)
Pages (from-to)1487-1496
Number of pages10
JournalNew England Journal of Medicine
Volume367
Issue number16
DOIs
StatePublished - Oct 18 2012

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Unrelated Donors
Bone Marrow
Confidence Intervals
Graft vs Host Disease
Blood Group Antigens
Bone Marrow Transplantation
Survival
Incidence
Transplantation
National Heart, Lung, and Blood Institute (U.S.)
Transplants
Peripheral Blood Stem Cell Transplantation
Recurrence
Intention to Treat Analysis
National Cancer Institute (U.S.)
Peripheral Blood Stem Cells
Multicenter Studies
Siblings
Leukemia
Survival Rate

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Anasetti, C., Logan, B. R., Lee, S. J., Waller, E. K., Weisdorf, D. J., Wingard, J. R., ... Confer, D. L. (2012). Peripheral-blood stem cells versus bone marrow from unrelated donors. New England Journal of Medicine, 367(16), 1487-1496. https://doi.org/10.1056/NEJMoa1203517
Anasetti, Claudio ; Logan, Brent R. ; Lee, Stephanie J. ; Waller, Edmund K. ; Weisdorf, Daniel J. ; Wingard, John R. ; Cutler, Corey S. ; Westervelt, Peter ; Woolfrey, Ann ; Couban, Stephen ; Ehninger, Gerhard ; Johnston, Laura ; Maziarz, Richard T. ; Pulsipher, Michael A. ; Porter, David L. ; Mineishi, Shin ; McCarty, John M. ; Khan, Shakila P. ; Anderlini, Paolo ; Bensinger, William I. ; Leitman, Susan F. ; Rowley, Scott D. ; Bredeson, Christopher ; Carter, Shelly L. ; Horowitz, Mary M. ; Confer, Dennis L. / Peripheral-blood stem cells versus bone marrow from unrelated donors. In: New England Journal of Medicine. 2012 ; Vol. 367, No. 16. pp. 1487-1496.
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abstract = "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.)",
author = "Claudio Anasetti and Logan, {Brent R.} and Lee, {Stephanie J.} and Waller, {Edmund K.} and Weisdorf, {Daniel J.} and Wingard, {John R.} and Cutler, {Corey S.} and Peter Westervelt and Ann Woolfrey and Stephen Couban and Gerhard Ehninger and Laura Johnston and Maziarz, {Richard T.} and Pulsipher, {Michael A.} and Porter, {David L.} and Shin Mineishi and McCarty, {John M.} and Khan, {Shakila P.} and Paolo Anderlini and Bensinger, {William I.} and Leitman, {Susan F.} and Rowley, {Scott D.} and Christopher Bredeson and Carter, {Shelly L.} and Horowitz, {Mary M.} and Confer, {Dennis L.}",
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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 2012, 'Peripheral-blood stem cells versus bone marrow from unrelated donors', New England Journal of Medicine, vol. 367, no. 16, pp. 1487-1496. https://doi.org/10.1056/NEJMoa1203517

Peripheral-blood stem cells versus bone marrow from unrelated donors. / Anasetti, Claudio; Logan, Brent R.; Lee, Stephanie J.; Waller, Edmund K.; Weisdorf, Daniel J.; Wingard, John R.; Cutler, Corey S.; Westervelt, Peter; Woolfrey, Ann; Couban, Stephen; Ehninger, Gerhard; Johnston, Laura; Maziarz, Richard T.; Pulsipher, Michael A.; Porter, David L.; Mineishi, Shin; McCarty, John M.; Khan, Shakila P.; Anderlini, Paolo; Bensinger, William I.; Leitman, Susan F.; Rowley, Scott D.; Bredeson, Christopher; Carter, Shelly L.; Horowitz, Mary M.; Confer, Dennis L.

In: New England Journal of Medicine, Vol. 367, No. 16, 18.10.2012, p. 1487-1496.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Peripheral-blood stem cells versus bone marrow from unrelated donors

AU - Anasetti, Claudio

AU - Logan, Brent R.

AU - Lee, Stephanie J.

AU - Waller, Edmund K.

AU - Weisdorf, Daniel J.

AU - Wingard, John R.

AU - Cutler, Corey S.

AU - Westervelt, Peter

AU - Woolfrey, Ann

AU - Couban, Stephen

AU - Ehninger, Gerhard

AU - Johnston, Laura

AU - Maziarz, Richard T.

AU - Pulsipher, Michael A.

AU - Porter, David L.

AU - Mineishi, Shin

AU - McCarty, John M.

AU - Khan, Shakila P.

AU - Anderlini, Paolo

AU - Bensinger, William I.

AU - Leitman, Susan F.

AU - Rowley, Scott D.

AU - Bredeson, Christopher

AU - Carter, Shelly L.

AU - Horowitz, Mary M.

AU - Confer, Dennis L.

PY - 2012/10/18

Y1 - 2012/10/18

N2 - 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.)

AB - 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.)

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Anasetti C, Logan BR, Lee SJ, Waller EK, Weisdorf DJ, Wingard JR et al. Peripheral-blood stem cells versus bone marrow from unrelated donors. New England Journal of Medicine. 2012 Oct 18;367(16):1487-1496. https://doi.org/10.1056/NEJMoa1203517