Recovery of Unrelated Donors of Peripheral Blood Stem Cells versus Recovery of Unrelated Donors of Bone Marrow: A Prespecified Analysis from the Phase III Blood and Marrow Transplant Clinical Trials Network Protocol 0201

Abstract

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.

Keywords: Donor; Gender; Graft-versus-host disease; Hematopoietic stem cell transplantation; Recipient.

Copyright © 2016 The American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1

Probability of complete recovery by donation of peripheral blood stem cells (PBSC0 or bone marrow (BM). (A) All donors, 2004–2005. (B) All donors, 2006–2007. (C) All donors, 2008–2009. (D) Domestic donors, 2004–2005. (E) Domestic donors, 2006–2007. (F) Domestic donors, 2008–2009.

Figure 1

Probability of complete recovery by donation of peripheral blood stem cells (PBSC0 or bone marrow (BM). (A) All donors, 2004–2005. (B) All donors, 2006–2007. (C) All donors, 2008–2009. (D) Domestic donors, 2004–2005. (E) Domestic donors, 2006–2007. (F) Domestic donors, 2008–2009.

Figure 1

Probability of complete recovery by donation of peripheral blood stem cells (PBSC0 or bone marrow (BM). (A) All donors, 2004–2005. (B) All donors, 2006–2007. (C) All donors, 2008–2009. (D) Domestic donors, 2004–2005. (E) Domestic donors, 2006–2007. (F) Domestic donors, 2008–2009.

Figure 1

Probability of complete recovery by donation of peripheral blood stem cells (PBSC0 or bone marrow (BM). (A) All donors, 2004–2005. (B) All donors, 2006–2007. (C) All donors, 2008–2009. (D) Domestic donors, 2004–2005. (E) Domestic donors, 2006–2007. (F) Domestic donors, 2008–2009.

Figure 2

Skeletal pain and body symptoms by donation of peripheral blood stem cells (PBSC) or bone marrow. (A) Skeletal pain experienced by all donors by product at baseline and post-donation. (B) Skeletal pain of domestic donors by product at baseline, peri-collection and post-donation. (C) Highest toxicity level across all body symptoms experienced by all donors by product at baseline and post-donation. (D) Highest toxicity level across all body symptoms by domestic donors by product at baseline, peri-collection, and post-donation. (E) Fatigue of all donors product at baseline and post-donation. (F) Fatigue by domestic donors by product at baseline, peri-collection, and post-donation. Peri-collection time points are day 5 of filgrastim administration for PBSC donors and day 2 following BM collection.

Figure 2

Skeletal pain and body symptoms by donation of peripheral blood stem cells (PBSC) or bone marrow. (A) Skeletal pain experienced by all donors by product at baseline and post-donation. (B) Skeletal pain of domestic donors by product at baseline, peri-collection and post-donation. (C) Highest toxicity level across all body symptoms experienced by all donors by product at baseline and post-donation. (D) Highest toxicity level across all body symptoms by domestic donors by product at baseline, peri-collection, and post-donation. (E) Fatigue of all donors product at baseline and post-donation. (F) Fatigue by domestic donors by product at baseline, peri-collection, and post-donation. Peri-collection time points are day 5 of filgrastim administration for PBSC donors and day 2 following BM collection.

Figure 2

Skeletal pain and body symptoms by donation of peripheral blood stem cells (PBSC) or bone marrow. (A) Skeletal pain experienced by all donors by product at baseline and post-donation. (B) Skeletal pain of domestic donors by product at baseline, peri-collection and post-donation. (C) Highest toxicity level across all body symptoms experienced by all donors by product at baseline and post-donation. (D) Highest toxicity level across all body symptoms by domestic donors by product at baseline, peri-collection, and post-donation. (E) Fatigue of all donors product at baseline and post-donation. (F) Fatigue by domestic donors by product at baseline, peri-collection, and post-donation. Peri-collection time points are day 5 of filgrastim administration for PBSC donors and day 2 following BM collection.

Figure 2

Skeletal pain and body symptoms by donation of peripheral blood stem cells (PBSC) or bone marrow. (A) Skeletal pain experienced by all donors by product at baseline and post-donation. (B) Skeletal pain of domestic donors by product at baseline, peri-collection and post-donation. (C) Highest toxicity level across all body symptoms experienced by all donors by product at baseline and post-donation. (D) Highest toxicity level across all body symptoms by domestic donors by product at baseline, peri-collection, and post-donation. (E) Fatigue of all donors product at baseline and post-donation. (F) Fatigue by domestic donors by product at baseline, peri-collection, and post-donation. Peri-collection time points are day 5 of filgrastim administration for PBSC donors and day 2 following BM collection.

Figure 2

Skeletal pain and body symptoms by donation of peripheral blood stem cells (PBSC) or bone marrow. (A) Skeletal pain experienced by all donors by product at baseline and post-donation. (B) Skeletal pain of domestic donors by product at baseline, peri-collection and post-donation. (C) Highest toxicity level across all body symptoms experienced by all donors by product at baseline and post-donation. (D) Highest toxicity level across all body symptoms by domestic donors by product at baseline, peri-collection, and post-donation. (E) Fatigue of all donors product at baseline and post-donation. (F) Fatigue by domestic donors by product at baseline, peri-collection, and post-donation. Peri-collection time points are day 5 of filgrastim administration for PBSC donors and day 2 following BM collection.

Figure 2

Skeletal pain and body symptoms by donation of peripheral blood stem cells (PBSC) or bone marrow. (A) Skeletal pain experienced by all donors by product at baseline and post-donation. (B) Skeletal pain of domestic donors by product at baseline, peri-collection and post-donation. (C) Highest toxicity level across all body symptoms experienced by all donors by product at baseline and post-donation. (D) Highest toxicity level across all body symptoms by domestic donors by product at baseline, peri-collection, and post-donation. (E) Fatigue of all donors product at baseline and post-donation. (F) Fatigue by domestic donors by product at baseline, peri-collection, and post-donation. Peri-collection time points are day 5 of filgrastim administration for PBSC donors and day 2 following BM collection.

Figure 3

Box and whiskers plots of (A) white blood cell (WBC) counts, (B) neutrophil counts, (C) mononuclear cell counts, (D) hemoglobin and (E) platelet counts, by randomized product of peripheral blood stem cells (PBSC) or bone marrow, showing the maximum, upper quartile, median, lower quartile, and minimum values at baseline and the indicated time post-donation: day of collection, 1 and 6 months, 1 and 2 years.

Figure 3

Box and whiskers plots of (A) white blood cell (WBC) counts, (B) neutrophil counts, (C) mononuclear cell counts, (D) hemoglobin and (E) platelet counts, by randomized product of peripheral blood stem cells (PBSC) or bone marrow, showing the maximum, upper quartile, median, lower quartile, and minimum values at baseline and the indicated time post-donation: day of collection, 1 and 6 months, 1 and 2 years.

Figure 3

Box and whiskers plots of (A) white blood cell (WBC) counts, (B) neutrophil counts, (C) mononuclear cell counts, (D) hemoglobin and (E) platelet counts, by randomized product of peripheral blood stem cells (PBSC) or bone marrow, showing the maximum, upper quartile, median, lower quartile, and minimum values at baseline and the indicated time post-donation: day of collection, 1 and 6 months, 1 and 2 years.