Paper: Related PBSC Donors Experience Higher Levels of Pain and Donation-Related Symptoms and Less Complete Rates of Recovery Compared to Unrelated Donors: Primary Analysis of the Related Donor Safety Study (RDSafe)

BMT Tandem "Scientific" Meeting

Seaport Ballroom DE (Manchester Grand Hyatt)

Michael A. Pulsipher, MD , Huntsman Cancer Institute, University of Utah School of Medicine, Salt Lake City, UT

Brent R. Logan, PhD , Division of Biostatistics, Medical College of Wisconsin, Milwaukee, WI

Deidre M. Kiefer, M.P.H. , Center for International Blood and Marrow Transplant Research, National Marrow Donor Program, Minneapolis, MN

Pintip Chitphakdithai, PhD , CIBMTR (Center for International Blood and Marrow Transplant Research), National Marrow Donor Program, Minneapolis, MN

Galen E. Switzer, PhD , University of Pittsburgh, Pittsburgh, PA

Marcie L. Riches, MD, MS , Blood and Marrow Transplantation, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL

J. Douglas Rizzo, MD, MS , CIBMTR (Center for International Blood and Marrow Transplant Research), CIBMTR and Medical College of Wisconsin, Milwaukee, WI

Paolo Anderlini, MD , Stem Cell Transplantation and Cellular Therapy, UT MD Anderson Cancer Center, Houston, TX

Susan F. Leitman, MD , Department of Transfusion Medicine, National Heart Lung and Blood Institute - NIH, Bethesda, MD

James W. Varni, PhD , Texas A&M University, College Station, TX

Hati Kobusingye, MS , CIBMTR (Center for International Blood and Marrow Transplant Research), National Marrow Donor Program, Minneapolis, MN

RaeAnne M. Besser, BS , CIBMTR (Center for International Blood and Marrow Transplant Research), National Marrow Donor Program, Minneapolis, MN

John P. Miller, MD, PhD , Department of Donor Medical Services, National Marrow Donor Program, Minneapolis, MN

Rebecca J. Drexler, BS, AAS , CIBMTR (Center for International Blood and Marrow Transplant Research), National Marrow Donor Program, Minneapolis, MN

Roberta J. King, MPH , CIBMTR/National Marrow Donor Program, Minneapolis, MN

Mary M. Horowitz, MD, MS , CIBMTR (Center for International Blood and Marrow Transplant Research), CIBMTR and Medical College of Wisconsin, Milwaukee, WI

Dennis L. Confer, MD , CIBMTR (Center for International Blood and Marrow Transplant Research), National Marrow Donor Program, Minneapolis, MN

Presentation recording not available for download or distribution as requested by the presenting author.

Prospective data regarding donation related toxicities in related donors (RDs) of bone marrow (BM) and peripheral blood stem cells (PBSC) are limited. To address this, the NHLBI-funded Related Donor Safety Study (RDSafe; NCT00948636) prospectively enrolled adult RDs between 2010 and 2013 at 54 transplant centers in the United States. RDs were assessed for baseline health status and followed for 1 year after donation, collecting detailed information on adverse events, pain levels and 10 donation-related modified NCI-CTC symptoms (MTC). A concurrently enrolled cohort of NMDP unrelated donors (URDs) was assessed as a comparator. This report compares baseline, donation, and 1 year post-donation pain/MTC for RDs aged 18-60: 124 BM (38 centers, med age 33, 48% female) and 919 PBSC (42 centers, med age 49, 44% female) to URDs: 1098 BM (18 centers, med age 31, 42% female) and 3119 PBSC (20 centers, med age 31, 40% female).

Results: RDs of PBSC had higher levels of baseline grade 2-4 pain and MTC compared to URDs; RDs of BM had higher baseline levels of pain, but not MTC (Table 1). Multivariable analysis (Table 2) showed similar donation-related pain and MTC rates of recovery for RDs and URDs of BM. In contrast, RDs of PBSC had significant increases in risk of donation-related grade 2-4 pain, grade 3-4 pain, and grade 2-4 MTC (Table 2) compared to URDs of PBSC. In addition, RDs of PBSC were less likely than URDs of PBSC to return to baseline levels of pain and MTC at 1 year. Although only a small fraction of both URDs and RDs reported grade 2-4 pain/MTC 1 year post-donation (Table 1), RDs were 2-3 times more likely to report pain/MTC at 1 year than URDs.

Conclusions: RDs of PBSC have more baseline and donation-related pain/MTC and less complete 1 year recovery than URDs. Ongoing analysis of baseline health status of RDs on the RDSafe trial is underway to further define differences between RDs/URDs that could account for these higher levels of pain/MTC.

Table 1. Baseline and 1 year post-donation pain/MTC, and rates of recovery to baseline levels

BM

PBSC

URDs

RDs

p-value

URDs

RDs

p-value

Baseline skeletal pain grade 2-4

0.46%

2.42%

0.039

0.61%

8.38%

<0.001

Baseline skeletal pain grade 3-4

0%

0%

1.000

0%

1.85%

<0.001

Baseline max MTC 2-4

0.82%

0.81%

1.000

0.51%

2.57%

<0.001

1yr skeletal pain 2-4

5.00%

10.64%

0.033

5.37%

14.27%

<0.001

1yr MTC 2-4

4.61%

7.45%

0.211

3.79%

6.04%

0.012

% back to baseline pain at 1 yr

77.11%

78.72%

0.795

78.32%

68.51%

<0.001

% back to baseline MTC at 1 yr

84.61%

87.10%

0.646

88.22%

83.31%

<0.001

Table 2. MV analysis of RDs vs. URDs pain/MTC. URDs OR = 1.0

OR RDs BM

p-value

OR RDs PBSC

p-value

Donation pain 2-4

1.20

0.352

1.63

<0.001

Donation pain 3-4

11.00

<0.001

Donation MTC 2-4

1.32

0.230

2.38

<0.001

Recovery to baseline pain 2-4

1.18

0.535

0.79

0.031

Recovery to baseline MTC 2-4

1.15

0.672

0.68

0.001

Disclosures:

Nothing To Disclose

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	BM			PBSC
	URDs	RDs	p-value	URDs	RDs	p-value
Baseline skeletal pain grade 2-4	0.46%	2.42%	0.039	0.61%	8.38%	<0.001
Baseline skeletal pain grade 3-4	0%	0%	1.000	0%	1.85%	<0.001
Baseline max MTC 2-4	0.82%	0.81%	1.000	0.51%	2.57%	<0.001
1yr skeletal pain 2-4	5.00%	10.64%	0.033	5.37%	14.27%	<0.001
1yr MTC 2-4	4.61%	7.45%	0.211	3.79%	6.04%	0.012
% back to baseline pain at 1 yr	77.11%	78.72%	0.795	78.32%	68.51%	<0.001
% back to baseline MTC at 1 yr	84.61%	87.10%	0.646	88.22%	83.31%	<0.001

	OR RDs BM	p-value	OR RDs PBSC	p-value
Donation pain 2-4	1.20	0.352	1.63	<0.001
Donation pain 3-4			11.00	<0.001
Donation MTC 2-4	1.32	0.230	2.38	<0.001
Recovery to baseline pain 2-4	1.18	0.535	0.79	0.031
Recovery to baseline MTC 2-4	1.15	0.672	0.68	0.001

20 Related PBSC Donors Experience Higher Levels of Pain and Donation-Related Symptoms and Less Complete Rates of Recovery Compared to Unrelated Donors: Primary Analysis of the Related Donor Safety Study (RDSafe)