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Clinical Trial
. 2013 Jan 3;121(1):197-206.
doi: 10.1182/blood-2012-03-417667. Epub 2012 Oct 29.

Acute toxicities of unrelated bone marrow versus peripheral blood stem cell donation: results of a prospective trial from the National Marrow Donor Program

Affiliations
Clinical Trial

Acute toxicities of unrelated bone marrow versus peripheral blood stem cell donation: results of a prospective trial from the National Marrow Donor Program

Michael A Pulsipher et al. Blood. .

Erratum in

  • Blood. 2014 Mar 20;123(12):1970

Abstract

Although peripheral blood stem cells (PBSCs) have replaced bone marrow (BM) as the most common unrelated donor progenitor cell product collected, a direct comparison of concurrent PBSC versus BM donation experiences has not been performed. We report a prospective study of 2726 BM and 6768 PBSC donors who underwent collection from 2004 to 2009. Pain and toxicities were assessed at baseline, during G-CSF administration, on the day of collection, within 48 hours of donation, and weekly until full recovery. Peak levels of pain and toxicities did not differ between the 2 donation processes for most donors. Among obese donors, PBSC donors were at increased risk of grade 2 to 4 pain as well as grade 2 to 4 toxicities during the pericollection period. In contrast, BM donors were more likely to experience grade 2 to 4 toxicities at 1 week and pain at 1 week and 1 month after the procedure. BM donors experienced slower recovery, with 3% still not fully recovered at 24 weeks, whereas 100% of PBSC donors had recovered. Other factors associated with toxicity included obesity, increasing age, and female sex. In summary, this study provides extensive detail regarding individualized risk patterns of PBSC versus BM donation toxicity, suggesting donor profiles that can be targeted with interventions to minimize toxicity.

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Figures

Figure 1
Figure 1
Donor blood counts at baseline, on the day of collection, and at postdonation follow-ups. (A) Donor white blood cell (WBC) counts. (B) Donor platelet counts. (C) Donor hemoglobin levels. Minimum, lower quartile, median, upper quartile, maximum; day 5 is the first day of apheresis; Pre and Post refer to the apheresis procedure.
Figure 2
Figure 2
Pain. (A) Skeletal pain experienced by bone marrow (BM) and peripheral blood stem cell (PBSC) donors at baseline, during the pericollection period, and after donation. (Skeletal pain represents pain in at least 1 of the following sites: back, bone, headache, hip, limb, joint, and neck.) The severity of skeletal pain is defined as the maximum grade among these pain sites. Day 2 is the second day of filgrastim; day 5 is the first day of apheresis. (B) Sites of pain among BM and PBSC donors on the day noted to have the highest severity of pain (1-2 days post-BM collection and day + 5 from start of G-CSF for PBSC).
Figure 3
Figure 3
Toxicities. (A) Highest toxicity level of key symptoms (fever in the absence of signs of infection, fatigue, skin rash, local reactions, nausea, vomiting, anorexia, insomnia, dizziness, and syncope) experienced by BM and PBSC donors at baseline, during pericollection period, and after donation. (Day 2 is the second day of filgrastim; day 5 is the first day of apheresis.) (B) Toxicities among BM and PBSC donors on the day noted to have the highest level of toxicity (1-2 days post-BM collection and day + 5 from start of G-CSF for PBSC). (C) Common toxicities among BM and PBSC donors on the day noted to have the highest level of toxicity (1-2 days post-BM collection and day + 5 from start of G-CSF for PBSC), and at selected time points after donation.
Figure 4
Figure 4
Univariate probability of reported complete recovery from stem cell donation.

References

    1. Miller JP, Perry EH, Price TH, et al. Recovery and safety profiles of marrow and PBSC donors: experience of the National Marrow Donor Program. Biol Blood Marrow Transplant. 2008;14(9 Suppl):29–36. - PubMed
    1. King RJ, Confer DL, Greinix HT, et al. Unrelated hematopoietic stem cell donors as research subjects. Bone Marrow Transplant. 2011;46(1):10–13. - PubMed
    1. Shaw BE, Ball L, Beksac M, et al. Donor safety: the role of the WMDA in ensuring the safety of volunteer unrelated donors: clinical and ethical considerations. Bone Marrow Transplant. 2010;45(5):832–838. - PubMed
    1. Pulsipher MA, Chitphakdithai P, Miller JP, et al. Adverse events among 2408 unrelated donors of peripheral blood stem cells: results of a prospective trial from the National Marrow Donor Program. Blood. 2009;113(15):3604–3611. - PMC - PubMed
    1. Switzer GE, Harrington D, Haagenson MD, et al. Health-related quality-of-life among adult matched unrelated stem cell donors: a Blood and Marrow Transplant Clinical Trials Network (BMT CTN) randomized trial of marrow versus PBSC donation [abstract]. Blood (ASH Annual Meeting Abstracts) 2010;116(21) Abstract 366.

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