Abstract
Although donation of bone marrow (BM)or peripheral blood stem cells (PBSCs)from children to family members undergoing allogeneic transplantation are well-established procedures, studies detailing levels of pain, symptoms, and long-term recovery are lacking. To address this lack, we prospectively enrolled 294 donors age <18 years at 25 pediatric transplantation centers in North America, assessing them predonation, peridonation, and at 1 month, 6 months, and 1 year postdonation. We noted that 71% of children reported pain and 59% reported other symptoms peridonation, with resolution to 14% and 12% at 1 month postdonation. Both older age (age 13 to 17 years versus younger)and female sex were associated with higher levels of pain peridonation, with the highest rates in older females (57% with grade 2-4 pain and 17% with grade 3-4 pain). Multivariate analyses showed a 4-fold increase in risk for older females compared with males age <13 years (P <.001). At 1 year, 11% of 13- to 17-year-old females reported grade 2-4 pain, compared with 3% of males age 13 to 17 years, 0% of females age <13 years, and 1% of males age <13 years (P =.01). Males and females age 13 to 17 years failed to return to predonation pain levels at 1 year 22% and 23% of the time, respectively, compared with 3% and 10% in males and females age <13 years (P =.002). Our data show that females age 13 to 17 years are at increased risk of grade 2-4 pain at 1 year and >20% of females and males age 13 to 17 years do not return to baseline pain levels by 1 year after BM donation. Studies aimed at decreasing symptoms and improving recovery in older children are warranted.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 955-964 |
| Number of pages | 10 |
| Journal | Biology of Blood and Marrow Transplantation |
| Volume | 25 |
| Issue number | 5 |
| DOIs | |
| State | Published - May 2019 |
Keywords
- BM collection toxicities
- Donor safety
- PBSC collection toxicities
- Stem cell transplantation
ASJC Scopus subject areas
- Hematology
- Transplantation
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Higher Risks of Toxicity and Incomplete Recovery in 13- to 17-Year-Old Females after Marrow Donation : RDSafe Peds Results. / Pulsipher, Michael A.; Logan, Brent R.; Kiefer, Deidre M. et al.
In: Biology of Blood and Marrow Transplantation, Vol. 25, No. 5, 05.2019, p. 955-964.Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - Higher Risks of Toxicity and Incomplete Recovery in 13- to 17-Year-Old Females after Marrow Donation
T2 - RDSafe Peds Results
AU - Pulsipher, Michael A.
AU - Logan, Brent R.
AU - Kiefer, Deidre M.
AU - Chitphakdithai, Pintip
AU - Riches, Marcie L.
AU - Rizzo, J. Douglas
AU - Anderlini, Paolo
AU - Leitman, Susan F.
AU - Varni, James W.
AU - Kobusingye, Hati
AU - Besser, Rae Anne M.
AU - Miller, John P.
AU - Drexler, Rebecca J.
AU - Abdel-Mageed, Aly
AU - Ahmed, Ibrahim A.
AU - Ball, Edward D.
AU - Bolwell, Brian J.
AU - Bunin, Nancy J.
AU - Cheerva, Alexandra
AU - Delgado, David C.
AU - Dvorak, Christopher C.
AU - Gillio, Alfred P.
AU - Hahn, Theresa E.
AU - Hale, Gregory A.
AU - Haight, Ann E.
AU - Hayes-Lattin, Brandon M.
AU - Kasow, Kimberly A.
AU - Linenberger, Michael
AU - Magalhaes-Silverman, Margarida
AU - Mori, Shahram
AU - Prasad, Vinod K.
AU - Quigg, Troy C.
AU - Sahdev, Indira
AU - Schriber, Jeffrey R.
AU - Shenoy, Shalini
AU - Tse, William T.
AU - Yanik, Gregory A.
AU - Navarro, Willis H.
AU - Horowitz, Mary M.
AU - Confer, Dennis L.
AU - Shaw, Bronwen E.
AU - Switzer, Galen E.
N1 - Funding Information: The CIBMTR is supported primarily by Public Health Service Grant/Cooperative Agreement 5U24CA076518 from the NCI, the NHLBI, and the National Institute of Allergy and Infectious Diseases ; Grant/Cooperative Agreement 1U24HL138660 from the NHLBI and NCI; Contract HHSH250201700006C with the Health Resources and Services Administration; Grants N00014-17-1-2388, N00014-17-1-2850, and N00014-18-1-2045 from the Office of Naval Research ; and grants from Adaptive Biotechnologies *Amgen, Anonymous donation to the Medical College of Wisconsin, Astellas Pharma US, Atara Biotherapeutics, Be the Match Foundation, *bluebird bio, *Bristol Myers Squibb Oncology, *Celgenetion *Chimerix, *CytoSen Therapeutics, Fred Hutchinson Cancer Research Center; Gamida Cell, Gilead Sciences, HistoGenetics, Immucor, *Incyte, Janssen Scientific Affairs, *Jazz Pharmaceuticals, Karius, Karyopharm Therapeutics, *Kite Pharma, Medac, *Mediware, The Medical College of Wisconsin, *Merck & Co, *Mesoblast, MesoScale Diagnostics, Millennium, Takeda Oncology, *Miltenyi Biotec, Mundipharma EDO, National Marrow Donor Program, Novartis Pharmaceuticals, PCORI, *Pfizer, *Pharmacyclics, PIRCHE, *Sanofi Genzyme, *Seattle Genetics, Shire, Spectrum Pharmaceuticals, St. Baldrick's Foundation, Swedish Orphan Biovitrum, *Takeda Oncology, and University of Minnesota. The views expressed in this article do not reflect the official policy or position of the National Institutes of Health, Department of the Navy, Department of Defense, Health Resources and Services Administration, or any other agency of the US Government. Funding Information: Financial disclosure: This study was funded by National Heart, Lung, and Blood Institute (NHLBI) Grant R01 HL085707. Additional funding for M.A.P. was provided by NHLBI/National Cancer Institute (NCI) Grant 2UG1HL069254 and a Johnny Crisstopher Children's Charitable Foundation St. Baldrick's Consortium Grant. Funding Information: With a lack of detailed data regarding the related HSC donor experience in mind and better donor evaluation tools in hand, a multi-institutional team joined with the NMDP/Center for International Blood and Marrow Transplant Research (CIBMTR)to implement the Related Donor Safety Study (RDSafe)funded by a grant from the US National Heart, Lung, and Blood Institute (NHLBI). This prospective observational trial enrolled related donors of all ages at 53 centers in the United States and prospectively collected detailed predonation and postdonation assessment data through 1 year postprocedure. This report details pain, toxicities, and SAEs occurring in 294 pediatric donors age <18 years who underwent collection at 25 centers between 2010 and 2014. Previously published quality of life studies in a large subset of this cohort reported the important findings that a portion of pediatric donors have significant decreases in health-related quality of life (HR-QoL)associated with the procedure [16], and there is a disconnect between parents? and children's perceptions of the donation process [17]. Those previous studies together with the present report provide the most comprehensive assessment of pediatric HSC donation to date.Financial disclosure: This study was funded by National Heart, Lung, and Blood Institute (NHLBI)Grant R01 HL085707. Additional funding for M.A.P. was provided by NHLBI/National Cancer Institute (NCI)Grant 2UG1HL069254 and a Johnny Crisstopher Children's Charitable Foundation St. Baldrick's Consortium Grant. The CIBMTR is supported primarily by Public Health Service Grant/Cooperative Agreement 5U24CA076518 from the NCI, the NHLBI, and the National Institute of Allergy and Infectious Diseases; Grant/Cooperative Agreement 1U24HL138660 from the NHLBI and NCI; Contract HHSH250201700006C with the Health Resources and Services Administration; Grants N00014-17-1-2388, N00014-17-1-2850, and N00014-18-1-2045 from the Office of Naval Research; and grants from Adaptive Biotechnologies *Amgen, Anonymous donation to the Medical College of Wisconsin, Astellas Pharma US, Atara Biotherapeutics, Be the Match Foundation, *bluebird bio, *Bristol Myers Squibb Oncology, *Celgenetion *Chimerix, *CytoSen Therapeutics, Fred Hutchinson Cancer Research Center; Gamida Cell, Gilead Sciences, HistoGenetics, Immucor, *Incyte, Janssen Scientific Affairs, *Jazz Pharmaceuticals, Karius, Karyopharm Therapeutics, *Kite Pharma, Medac, *Mediware, The Medical College of Wisconsin, *Merck & Co, *Mesoblast, MesoScale Diagnostics, Millennium, Takeda Oncology, *Miltenyi Biotec, Mundipharma EDO, National Marrow Donor Program, Novartis Pharmaceuticals, PCORI, *Pfizer, *Pharmacyclics, PIRCHE, *Sanofi Genzyme, *Seattle Genetics, Shire, Spectrum Pharmaceuticals, St. Baldrick's Foundation, Swedish Orphan Biovitrum, *Takeda Oncology, and University of Minnesota. The views expressed in this article do not reflect the official policy or position of the National Institutes of Health, Department of the Navy, Department of Defense, Health Resources and Services Administration, or any other agency of the US Government. *Corporate member. Conflict of interest statement: There are no conflicts of interest to report. Authorship statement: M.A.P. P.A. D.L.C. R.J.D. M.M.H. S.F.L. B.R.L. J.P.M. J.D.R. G.E.S. M.L.R. and J.W.V. designed the trial. M.A.P. W.N. B.E.S. H.K. R.M.B. and R.J.D. oversaw and conducted the study. M.A.P. B.E.S. B.R.L. D.M.K. and P.C. analyzed and interpreted the data and wrote the manuscript. M.A.P. M.L.R. A.A.M. I.A.A. E.D.B. B.J.B. N.J.B. A.C. K.D. C.C.D. A.P.G. T.E.H. G.A.H. A.E.H. B.H.L. K.A.K. M.L. S.M. V.K.P. T.C.Q. I.S. J.S. S.S. M.M.S. W.T. J.P.U. M.V. and G.A.Y. enrolled related donors. All authors reviewed and approved the final manuscript. Publisher Copyright: © 2019
PY - 2019/5
Y1 - 2019/5
N2 - Although donation of bone marrow (BM)or peripheral blood stem cells (PBSCs)from children to family members undergoing allogeneic transplantation are well-established procedures, studies detailing levels of pain, symptoms, and long-term recovery are lacking. To address this lack, we prospectively enrolled 294 donors age <18 years at 25 pediatric transplantation centers in North America, assessing them predonation, peridonation, and at 1 month, 6 months, and 1 year postdonation. We noted that 71% of children reported pain and 59% reported other symptoms peridonation, with resolution to 14% and 12% at 1 month postdonation. Both older age (age 13 to 17 years versus younger)and female sex were associated with higher levels of pain peridonation, with the highest rates in older females (57% with grade 2-4 pain and 17% with grade 3-4 pain). Multivariate analyses showed a 4-fold increase in risk for older females compared with males age <13 years (P <.001). At 1 year, 11% of 13- to 17-year-old females reported grade 2-4 pain, compared with 3% of males age 13 to 17 years, 0% of females age <13 years, and 1% of males age <13 years (P =.01). Males and females age 13 to 17 years failed to return to predonation pain levels at 1 year 22% and 23% of the time, respectively, compared with 3% and 10% in males and females age <13 years (P =.002). Our data show that females age 13 to 17 years are at increased risk of grade 2-4 pain at 1 year and >20% of females and males age 13 to 17 years do not return to baseline pain levels by 1 year after BM donation. Studies aimed at decreasing symptoms and improving recovery in older children are warranted.
AB - Although donation of bone marrow (BM)or peripheral blood stem cells (PBSCs)from children to family members undergoing allogeneic transplantation are well-established procedures, studies detailing levels of pain, symptoms, and long-term recovery are lacking. To address this lack, we prospectively enrolled 294 donors age <18 years at 25 pediatric transplantation centers in North America, assessing them predonation, peridonation, and at 1 month, 6 months, and 1 year postdonation. We noted that 71% of children reported pain and 59% reported other symptoms peridonation, with resolution to 14% and 12% at 1 month postdonation. Both older age (age 13 to 17 years versus younger)and female sex were associated with higher levels of pain peridonation, with the highest rates in older females (57% with grade 2-4 pain and 17% with grade 3-4 pain). Multivariate analyses showed a 4-fold increase in risk for older females compared with males age <13 years (P <.001). At 1 year, 11% of 13- to 17-year-old females reported grade 2-4 pain, compared with 3% of males age 13 to 17 years, 0% of females age <13 years, and 1% of males age <13 years (P =.01). Males and females age 13 to 17 years failed to return to predonation pain levels at 1 year 22% and 23% of the time, respectively, compared with 3% and 10% in males and females age <13 years (P =.002). Our data show that females age 13 to 17 years are at increased risk of grade 2-4 pain at 1 year and >20% of females and males age 13 to 17 years do not return to baseline pain levels by 1 year after BM donation. Studies aimed at decreasing symptoms and improving recovery in older children are warranted.
KW - BM collection toxicities
KW - Donor safety
KW - PBSC collection toxicities
KW - Stem cell transplantation
UR - http://www.scopus.com/inward/record.url?scp=85061429566&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85061429566&partnerID=8YFLogxK
U2 - 10.1016/j.bbmt.2018.12.765
DO - 10.1016/j.bbmt.2018.12.765
M3 - Article
C2 - 30605731
AN - SCOPUS:85061429566
SN - 1083-8791
VL - 25
SP - 955
EP - 964
JO - Biology of Blood and Marrow Transplantation
JF - Biology of Blood and Marrow Transplantation
IS - 5
ER -