Related peripheral blood stem cell donors experience more severe symptoms and less complete recovery at one year compared to unrelated donors

Michael A. Pulsipher; Brent R. Logan; Deidre M. Kiefer; Pintip Chitphakdithai; Marcie L. Riches; J. Douglas Rizzo; Paolo Anderlini; Susan F. Leitman; Hati Kobusingye; Raeanne M. Besser; John P. Miller; Rebecca J. Drexler; Aly Abdel-Mageed; Ibrahim A. Ahmed; Luke P. Akard; Andrew S. Artz; Edward D. Ball; Ruthee Lu Bayer; Carolyn Bigelow; Brian J. Bolwell; E. Randolph Broun; David C. Delgado; Katharine Duckworth; Christopher C. Dvorak; Theresa E. Hahn; Ann E. Haight; Parameswaran N. Hari; Brandon M. Hayes-Lattin; David A. Jacobsohn; Ann A. Jakubowski; Kimberly A. Kasow; Hillard M. Lazarus; Jane L. Liesveld; Michael Linenberger; Mark R. Litzow; Walter Longo; Margarida Magalhaes-Silverman; John M. McCarty; Joseph P. McGuirk; Shahram Mori; Vinod Parameswaran; Vinod K. Prasad; Scott D. Rowley; Witold B. Rybka; Indira Sahdev; Jeffrey R. Schriber; George B. Selby; Paul J. Shaughnessy; Shalini Shenoy; Thomas Spitzer; William T. Tse; Joseph P. Uberti; Madhuri Vusirikala; Edmund K. Waller; Daniel J. Weisdorf; Gregory A. Yanik; Willis H. Navarro; Mary M. Horowitz; Galen E. Switzer; Dennis L. Confer; Bronwen E. Shaw

doi:10.3324/haematol.2018.200121

Related peripheral blood stem cell donors experience more severe symptoms and less complete recovery at one year compared to unrelated donors

Michael A. Pulsipher, Brent R. Logan, Deidre M. Kiefer, Pintip Chitphakdithai, Marcie L. Riches, J. Douglas Rizzo, Paolo Anderlini, Susan F. Leitman, Hati Kobusingye, Raeanne M. Besser, John P. Miller, Rebecca J. Drexler, Aly Abdel-Mageed, Ibrahim A. Ahmed, Luke P. Akard, Andrew S. Artz, Edward D. Ball, Ruthee Lu Bayer, Carolyn Bigelow, Brian J. BolwellE. Randolph Broun, David C. Delgado, Katharine Duckworth, Christopher C. Dvorak, Theresa E. Hahn, Ann E. Haight, Parameswaran N. Hari, Brandon M. Hayes-Lattin, David A. Jacobsohn, Ann A. Jakubowski, Kimberly A. Kasow, Hillard M. Lazarus, Jane L. Liesveld, Michael Linenberger, Mark R. Litzow, Walter Longo, Margarida Magalhaes-Silverman, John M. McCarty, Joseph P. McGuirk, Shahram Mori, Vinod Parameswaran, Vinod K. Prasad, Scott D. Rowley, Witold B. Rybka, Indira Sahdev, Jeffrey R. Schriber, George B. Selby, Paul J. Shaughnessy, Shalini Shenoy, Thomas Spitzer, William T. Tse, Joseph P. Uberti, Madhuri Vusirikala, Edmund K. Waller, Daniel J. Weisdorf, Gregory A. Yanik, Willis H. Navarro, Mary M. Horowitz, Galen E. Switzer, Dennis L. Confer, Bronwen E. Shaw

Medicine - Hematology, Oncology, Transplant

Research output: Contribution to journal › Article › peer-review

10 Scopus citations

Abstract

Unlike unrelated donor registries, transplant centers lack uniform approaches to related donor assessment and deferral. To test whether related donors are at increased risk for donation-related toxicities, we conducted a prospective observational trial of 11,942 related and unrelated donors aged 18-60 years. Bone marrow (BM) was collected at 37 transplant and 78 National Marrow Donor Program centers, and peripheral blood stem cells (PBSC) were collected at 42 transplant and 87 unrelated donor centers in North America. Possible presence of medical comorbidities was verified prior to donation, and standardized pain and toxicity measures were assessed pre-donation, peri-donation, and one year following. Multivariate analyses showed similar experiences for BM collection in related and unrelated donors; however, related stem cell donors had increased risk of moderate [odds ratios (ORs) 1.42; P<0.001] and severe (OR 8.91; P<0.001) pain and toxicities (OR 1.84; P<0.001) with collection. Related stem cell donors were at increased risk of persistent toxicities (OR 1.56; P=0.021) and non-recovery from pain (OR 1.42; P=0.001) at one year. Related donors with more significant comorbidities were at especially high risk for grade 2-4 pain (OR 3.43; P<0.001) and non-recovery from toxicities (OR 3.71; P<0.001) at one year. Related donors with more significant comorbidities were at especially high risk for grade 2-4 pain (OR 3.43; P<0.001) and non-recovery from toxicities (OR 3.71; P<0.001) at one year. Related donors reporting grade ≥2 pain had significant decreases in Health-Related Quality of Life (HR-QoL) scores at one month and one year post donation (P=0.004). In conclusion, related PBSC donors with comorbidities are at increased risk for pain, toxicity, and non-recovery at one year after donation. Risk profiles described in this study should be used for donor education, planning studies to improve the related donor experience, and decisions regarding donor deferral. Registered at clinicaltrials.gov identifier: 00948636.

Original language	English (US)
Pages (from-to)	844-854
Number of pages	11
Journal	Haematologica
Volume	104
Issue number	4
DOIs	https://doi.org/10.3324/haematol.2018.200121
State	Published - Mar 31 2019

Bibliographical note

Funding Information:
The study was funded by R01 HL085707 through the NHLBI. Additional funding for MAP was provided by 2UG1HL069254 (NHLBI/NCI) and the 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 National Cancer Institute (NCI), the National Heart, Lung and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID); a Grant/Cooperative Agreement 1U24HL138660 from NHLBI and NCI; a contract HHSH250201700006C with Health Resources and Services Administration (HRSA/DHHS); two 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, Inc.; Anonymous donation to the Medical College of Wisconsin; Astellas Pharma US; Atara Biotherapeutics, Inc.; Be the Match Foundation; *bluebird bio, Inc.; *Bristol Myers Squibb Oncology; *Celgene Corporation; *Chimerix, Inc.; *CytoSen Therapeutics, Inc.; Fred Hutchinson Cancer Research Center; Gamida Cell Ltd.; Gilead Sciences, Inc.; HistoGenetics, Inc.; Immucor; *Incyte Corporation; Janssen Scientific Affairs, LLC; *Jazz Pharmaceuticals, Inc.; Karius, Inc.; Karyopharm Therapeutics, Inc.; *Kite Pharma, Inc.; Medac, GmbH; *Mediware; The Medical College of Wisconsin; *Merck & Co, Inc.; *Mesoblast; MesoScale Diagnostics, Inc.; Millennium, the Takeda Oncology ‏C‏o.; *Miltenyi Biotec, Inc.; Mundipharma EDO; National Marrow Donor Program; Novartis Pharmaceuticals Corporation; PCORI; *Pfizer, Inc; *Pharmacyclics, LLC; PIRCHE AG; *Sanofi Genzyme; *Seattle Genetics; Shire; Spectrum Pharmaceuticals, Inc.; St. Baldrick’s Foundation; Swedish Orphan Biovitrum, Inc.; *Takeda Oncology; and University of Minnesota. The views expressed in this article do not reflect the official policy or position of the National Institute of Health, the Department of the Navy, the Department of Defense, Health Resources and Services Administration (HRSA) or any other agency of the U.S. Government. *Corporate Members.

Funding Information:
The study was funded by R01 HL085707 through the NHLBI. Additional funding for MAP was provided by 2UG1HL069254 (NHLBI/NCI) and the 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 National Cancer Institute (NCI), the National Heart, Lung and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID); a Grant/Cooperative Agreement 1U24HL138660 from NHLBI and NCI; a contract HHSH250201700006C with Health Resources and Services Administration (HRSA/DHHS); two 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, Inc.; Anonymous donation to the Medical College of Wisconsin; Astellas Pharma US; Atara Biotherapeutics, Inc.; Be the Match Foundation; *bluebird bio, Inc.; *Bristol Myers Squibb Oncology; *Celgene Corporation; *Chimerix, Inc.; *CytoSen Therapeutics, Inc.; Fred Hutchinson Cancer Research Center; Gamida Cell Ltd.; Gilead Sciences, Inc.; HistoGenetics, Inc.; Immucor; *Incyte Corporation; Janssen Scientific Affairs, LLC; *Jazz Pharmaceuticals, Inc.; Karius, Inc.; Karyopharm Therapeutics, Inc.; *Kite Pharma, Inc.; Medac, GmbH; *Mediware; The Medical College of Wisconsin; *Merck & Co, Inc.; *Mesoblast; MesoScale Diagnostics, Inc.; Millennium, the Takeda Oncology Co.; *Miltenyi Biotec, Inc.; Mundipharma EDO; National Marrow Donor Program; Novartis Pharmaceuticals Corporation; PCORI; *Pfizer, Inc; *Pharmacyclics, LLC; PIRCHE AG; *Sanofi Genzyme; *Seattle Genetics; Shire; Spectrum Pharmaceuticals, Inc.; St. Baldrick’s Foundation; Swedish Orphan Biovitrum, Inc.; *Takeda Oncology; and University of Minnesota. The views expressed in this article do not reflect the official policy or position of the National Institute of Health, the Department of the Navy, the Department of Defense, Health Resources and Services Administration (HRSA) or any other agency of the U.S. Government. *Corporate Members.

Publisher Copyright:
© 2019 Ferrata Storti Foundation.

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Pulsipher, M. A., Logan, B. R., Kiefer, D. M., Chitphakdithai, P., Riches, M. L., Rizzo, J. D., Anderlini, P., Leitman, S. F., Kobusingye, H., Besser, R. M., Miller, J. P., Drexler, R. J., Abdel-Mageed, A., Ahmed, I. A., Akard, L. P., Artz, A. S., Ball, E. D., Bayer, R. L., Bigelow, C., ... Shaw, B. E. (2019). Related peripheral blood stem cell donors experience more severe symptoms and less complete recovery at one year compared to unrelated donors. Haematologica, 104(4), 844-854. https://doi.org/10.3324/haematol.2018.200121

Pulsipher, MA, Logan, BR, Kiefer, DM, Chitphakdithai, P, Riches, ML, Rizzo, JD, Anderlini, P, Leitman, SF, Kobusingye, H, Besser, RM, Miller, JP, Drexler, RJ, Abdel-Mageed, A, Ahmed, IA, Akard, LP, Artz, AS, Ball, ED, Bayer, RL, Bigelow, C, Bolwell, BJ, Broun, ER, Delgado, DC, Duckworth, K, Dvorak, CC, Hahn, TE, Haight, AE, Hari, PN, Hayes-Lattin, BM, Jacobsohn, DA, Jakubowski, AA, Kasow, KA, Lazarus, HM, Liesveld, JL, Linenberger, M, Litzow, MR, Longo, W, Magalhaes-Silverman, M, McCarty, JM, McGuirk, JP, Mori, S, Parameswaran, V, Prasad, VK, Rowley, SD, Rybka, WB, Sahdev, I, Schriber, JR, Selby, GB, Shaughnessy, PJ, Shenoy, S, Spitzer, T, Tse, WT, Uberti, JP, Vusirikala, M, Waller, EK, Weisdorf, DJ, Yanik, GA, Navarro, WH, Horowitz, MM, Switzer, GE, Confer, DL & Shaw, BE 2019, 'Related peripheral blood stem cell donors experience more severe symptoms and less complete recovery at one year compared to unrelated donors', Haematologica, vol. 104, no. 4, pp. 844-854. https://doi.org/10.3324/haematol.2018.200121

@article{3536ca05956243debd2a49d0edc21235,

title = "Related peripheral blood stem cell donors experience more severe symptoms and less complete recovery at one year compared to unrelated donors",

abstract = "Unlike unrelated donor registries, transplant centers lack uniform approaches to related donor assessment and deferral. To test whether related donors are at increased risk for donation-related toxicities, we conducted a prospective observational trial of 11,942 related and unrelated donors aged 18-60 years. Bone marrow (BM) was collected at 37 transplant and 78 National Marrow Donor Program centers, and peripheral blood stem cells (PBSC) were collected at 42 transplant and 87 unrelated donor centers in North America. Possible presence of medical comorbidities was verified prior to donation, and standardized pain and toxicity measures were assessed pre-donation, peri-donation, and one year following. Multivariate analyses showed similar experiences for BM collection in related and unrelated donors; however, related stem cell donors had increased risk of moderate [odds ratios (ORs) 1.42; P<0.001] and severe (OR 8.91; P<0.001) pain and toxicities (OR 1.84; P<0.001) with collection. Related stem cell donors were at increased risk of persistent toxicities (OR 1.56; P=0.021) and non-recovery from pain (OR 1.42; P=0.001) at one year. Related donors with more significant comorbidities were at especially high risk for grade 2-4 pain (OR 3.43; P<0.001) and non-recovery from toxicities (OR 3.71; P<0.001) at one year. Related donors with more significant comorbidities were at especially high risk for grade 2-4 pain (OR 3.43; P<0.001) and non-recovery from toxicities (OR 3.71; P<0.001) at one year. Related donors reporting grade ≥2 pain had significant decreases in Health-Related Quality of Life (HR-QoL) scores at one month and one year post donation (P=0.004). In conclusion, related PBSC donors with comorbidities are at increased risk for pain, toxicity, and non-recovery at one year after donation. Risk profiles described in this study should be used for donor education, planning studies to improve the related donor experience, and decisions regarding donor deferral. Registered at clinicaltrials.gov identifier: 00948636.",

author = "Pulsipher, {Michael A.} and Logan, {Brent R.} and Kiefer, {Deidre M.} and Pintip Chitphakdithai and Riches, {Marcie L.} and Rizzo, {J. Douglas} and Paolo Anderlini and Leitman, {Susan F.} and Hati Kobusingye and Besser, {Raeanne M.} and Miller, {John P.} and Drexler, {Rebecca J.} and Aly Abdel-Mageed and Ahmed, {Ibrahim A.} and Akard, {Luke P.} and Artz, {Andrew S.} and Ball, {Edward D.} and Bayer, {Ruthee Lu} and Carolyn Bigelow and Bolwell, {Brian J.} and Broun, {E. Randolph} and Delgado, {David C.} and Katharine Duckworth and Dvorak, {Christopher C.} and Hahn, {Theresa E.} and Haight, {Ann E.} and Hari, {Parameswaran N.} and Hayes-Lattin, {Brandon M.} and Jacobsohn, {David A.} and Jakubowski, {Ann A.} and Kasow, {Kimberly A.} and Lazarus, {Hillard M.} and Liesveld, {Jane L.} and Michael Linenberger and Litzow, {Mark R.} and Walter Longo and Margarida Magalhaes-Silverman and McCarty, {John M.} and McGuirk, {Joseph P.} and Shahram Mori and Vinod Parameswaran and Prasad, {Vinod K.} and Rowley, {Scott D.} and Rybka, {Witold B.} and Indira Sahdev and Schriber, {Jeffrey R.} and Selby, {George B.} and Shaughnessy, {Paul J.} and Shalini Shenoy and Thomas Spitzer and Tse, {William T.} and Uberti, {Joseph P.} and Madhuri Vusirikala and Waller, {Edmund K.} and Weisdorf, {Daniel J.} and Yanik, {Gregory A.} and Navarro, {Willis H.} and Horowitz, {Mary M.} and Switzer, {Galen E.} and Confer, {Dennis L.} and Shaw, {Bronwen E.}",

note = "Funding Information: The study was funded by R01 HL085707 through the NHLBI. Additional funding for MAP was provided by 2UG1HL069254 (NHLBI/NCI) and the Johnny Crisstopher Children{\textquoteright}s Charitable Foundation St. Baldrick{\textquoteright}s Consortium Grant. The CIBMTR is supported primarily by Public Health Service Grant/Cooperative Agreement 5U24CA076518 from the National Cancer Institute (NCI), the National Heart, Lung and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID); a Grant/Cooperative Agreement 1U24HL138660 from NHLBI and NCI; a contract HHSH250201700006C with Health Resources and Services Administration (HRSA/DHHS); two 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, Inc.; Anonymous donation to the Medical College of Wisconsin; Astellas Pharma US; Atara Biotherapeutics, Inc.; Be the Match Foundation; *bluebird bio, Inc.; *Bristol Myers Squibb Oncology; *Celgene Corporation; *Chimerix, Inc.; *CytoSen Therapeutics, Inc.; Fred Hutchinson Cancer Research Center; Gamida Cell Ltd.; Gilead Sciences, Inc.; HistoGenetics, Inc.; Immucor; *Incyte Corporation; Janssen Scientific Affairs, LLC; *Jazz Pharmaceuticals, Inc.; Karius, Inc.; Karyopharm Therapeutics, Inc.; *Kite Pharma, Inc.; Medac, GmbH; *Mediware; The Medical College of Wisconsin; *Merck & Co, Inc.; *Mesoblast; MesoScale Diagnostics, Inc.; Millennium, the Takeda Oncology ‏C‏o.; *Miltenyi Biotec, Inc.; Mundipharma EDO; National Marrow Donor Program; Novartis Pharmaceuticals Corporation; PCORI; *Pfizer, Inc; *Pharmacyclics, LLC; PIRCHE AG; *Sanofi Genzyme; *Seattle Genetics; Shire; Spectrum Pharmaceuticals, Inc.; St. Baldrick{\textquoteright}s Foundation; Swedish Orphan Biovitrum, Inc.; *Takeda Oncology; and University of Minnesota. The views expressed in this article do not reflect the official policy or position of the National Institute of Health, the Department of the Navy, the Department of Defense, Health Resources and Services Administration (HRSA) or any other agency of the U.S. Government. *Corporate Members. Funding Information: The study was funded by R01 HL085707 through the NHLBI. Additional funding for MAP was provided by 2UG1HL069254 (NHLBI/NCI) and the Johnny Crisstopher Children{\textquoteright}s Charitable Foundation St. Baldrick{\textquoteright}s Consortium Grant. The CIBMTR is supported primarily by Public Health Service Grant/Cooperative Agreement 5U24CA076518 from the National Cancer Institute (NCI), the National Heart, Lung and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID); a Grant/Cooperative Agreement 1U24HL138660 from NHLBI and NCI; a contract HHSH250201700006C with Health Resources and Services Administration (HRSA/DHHS); two 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, Inc.; Anonymous donation to the Medical College of Wisconsin; Astellas Pharma US; Atara Biotherapeutics, Inc.; Be the Match Foundation; *bluebird bio, Inc.; *Bristol Myers Squibb Oncology; *Celgene Corporation; *Chimerix, Inc.; *CytoSen Therapeutics, Inc.; Fred Hutchinson Cancer Research Center; Gamida Cell Ltd.; Gilead Sciences, Inc.; HistoGenetics, Inc.; Immucor; *Incyte Corporation; Janssen Scientific Affairs, LLC; *Jazz Pharmaceuticals, Inc.; Karius, Inc.; Karyopharm Therapeutics, Inc.; *Kite Pharma, Inc.; Medac, GmbH; *Mediware; The Medical College of Wisconsin; *Merck & Co, Inc.; *Mesoblast; MesoScale Diagnostics, Inc.; Millennium, the Takeda Oncology Co.; *Miltenyi Biotec, Inc.; Mundipharma EDO; National Marrow Donor Program; Novartis Pharmaceuticals Corporation; PCORI; *Pfizer, Inc; *Pharmacyclics, LLC; PIRCHE AG; *Sanofi Genzyme; *Seattle Genetics; Shire; Spectrum Pharmaceuticals, Inc.; St. Baldrick{\textquoteright}s Foundation; Swedish Orphan Biovitrum, Inc.; *Takeda Oncology; and University of Minnesota. The views expressed in this article do not reflect the official policy or position of the National Institute of Health, the Department of the Navy, the Department of Defense, Health Resources and Services Administration (HRSA) or any other agency of the U.S. Government. *Corporate Members. Publisher Copyright: {\textcopyright} 2019 Ferrata Storti Foundation.",

year = "2019",

month = mar,

day = "31",

doi = "10.3324/haematol.2018.200121",

language = "English (US)",

volume = "104",

pages = "844--854",

journal = "Haematologica",

issn = "0390-6078",

publisher = "Ferrata Storti Foundation",

number = "4",

}

TY - JOUR

T1 - Related peripheral blood stem cell donors experience more severe symptoms and less complete recovery at one year compared to unrelated donors

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 - Kobusingye, Hati

AU - Besser, Raeanne M.

AU - Miller, John P.

AU - Drexler, Rebecca J.

AU - Abdel-Mageed, Aly

AU - Ahmed, Ibrahim A.

AU - Akard, Luke P.

AU - Artz, Andrew S.

AU - Ball, Edward D.

AU - Bayer, Ruthee Lu

AU - Bigelow, Carolyn

AU - Bolwell, Brian J.

AU - Broun, E. Randolph

AU - Delgado, David C.

AU - Duckworth, Katharine

AU - Dvorak, Christopher C.

AU - Hahn, Theresa E.

AU - Haight, Ann E.

AU - Hari, Parameswaran N.

AU - Hayes-Lattin, Brandon M.

AU - Jacobsohn, David A.

AU - Jakubowski, Ann A.

AU - Kasow, Kimberly A.

AU - Lazarus, Hillard M.

AU - Liesveld, Jane L.

AU - Linenberger, Michael

AU - Litzow, Mark R.

AU - Longo, Walter

AU - Magalhaes-Silverman, Margarida

AU - McCarty, John M.

AU - McGuirk, Joseph P.

AU - Mori, Shahram

AU - Parameswaran, Vinod

AU - Prasad, Vinod K.

AU - Rowley, Scott D.

AU - Rybka, Witold B.

AU - Sahdev, Indira

AU - Schriber, Jeffrey R.

AU - Selby, George B.

AU - Shaughnessy, Paul J.

AU - Shenoy, Shalini

AU - Spitzer, Thomas

AU - Tse, William T.

AU - Uberti, Joseph P.

AU - Vusirikala, Madhuri

AU - Waller, Edmund K.

AU - Weisdorf, Daniel J.

AU - Yanik, Gregory A.

AU - Navarro, Willis H.

AU - Horowitz, Mary M.

AU - Switzer, Galen E.

AU - Confer, Dennis L.

AU - Shaw, Bronwen E.

N1 - Funding Information: The study was funded by R01 HL085707 through the NHLBI. Additional funding for MAP was provided by 2UG1HL069254 (NHLBI/NCI) and the 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 National Cancer Institute (NCI), the National Heart, Lung and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID); a Grant/Cooperative Agreement 1U24HL138660 from NHLBI and NCI; a contract HHSH250201700006C with Health Resources and Services Administration (HRSA/DHHS); two 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, Inc.; Anonymous donation to the Medical College of Wisconsin; Astellas Pharma US; Atara Biotherapeutics, Inc.; Be the Match Foundation; *bluebird bio, Inc.; *Bristol Myers Squibb Oncology; *Celgene Corporation; *Chimerix, Inc.; *CytoSen Therapeutics, Inc.; Fred Hutchinson Cancer Research Center; Gamida Cell Ltd.; Gilead Sciences, Inc.; HistoGenetics, Inc.; Immucor; *Incyte Corporation; Janssen Scientific Affairs, LLC; *Jazz Pharmaceuticals, Inc.; Karius, Inc.; Karyopharm Therapeutics, Inc.; *Kite Pharma, Inc.; Medac, GmbH; *Mediware; The Medical College of Wisconsin; *Merck & Co, Inc.; *Mesoblast; MesoScale Diagnostics, Inc.; Millennium, the Takeda Oncology ‏C‏o.; *Miltenyi Biotec, Inc.; Mundipharma EDO; National Marrow Donor Program; Novartis Pharmaceuticals Corporation; PCORI; *Pfizer, Inc; *Pharmacyclics, LLC; PIRCHE AG; *Sanofi Genzyme; *Seattle Genetics; Shire; Spectrum Pharmaceuticals, Inc.; St. Baldrick’s Foundation; Swedish Orphan Biovitrum, Inc.; *Takeda Oncology; and University of Minnesota. The views expressed in this article do not reflect the official policy or position of the National Institute of Health, the Department of the Navy, the Department of Defense, Health Resources and Services Administration (HRSA) or any other agency of the U.S. Government. *Corporate Members. Funding Information: The study was funded by R01 HL085707 through the NHLBI. Additional funding for MAP was provided by 2UG1HL069254 (NHLBI/NCI) and the 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 National Cancer Institute (NCI), the National Heart, Lung and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID); a Grant/Cooperative Agreement 1U24HL138660 from NHLBI and NCI; a contract HHSH250201700006C with Health Resources and Services Administration (HRSA/DHHS); two 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, Inc.; Anonymous donation to the Medical College of Wisconsin; Astellas Pharma US; Atara Biotherapeutics, Inc.; Be the Match Foundation; *bluebird bio, Inc.; *Bristol Myers Squibb Oncology; *Celgene Corporation; *Chimerix, Inc.; *CytoSen Therapeutics, Inc.; Fred Hutchinson Cancer Research Center; Gamida Cell Ltd.; Gilead Sciences, Inc.; HistoGenetics, Inc.; Immucor; *Incyte Corporation; Janssen Scientific Affairs, LLC; *Jazz Pharmaceuticals, Inc.; Karius, Inc.; Karyopharm Therapeutics, Inc.; *Kite Pharma, Inc.; Medac, GmbH; *Mediware; The Medical College of Wisconsin; *Merck & Co, Inc.; *Mesoblast; MesoScale Diagnostics, Inc.; Millennium, the Takeda Oncology Co.; *Miltenyi Biotec, Inc.; Mundipharma EDO; National Marrow Donor Program; Novartis Pharmaceuticals Corporation; PCORI; *Pfizer, Inc; *Pharmacyclics, LLC; PIRCHE AG; *Sanofi Genzyme; *Seattle Genetics; Shire; Spectrum Pharmaceuticals, Inc.; St. Baldrick’s Foundation; Swedish Orphan Biovitrum, Inc.; *Takeda Oncology; and University of Minnesota. The views expressed in this article do not reflect the official policy or position of the National Institute of Health, the Department of the Navy, the Department of Defense, Health Resources and Services Administration (HRSA) or any other agency of the U.S. Government. *Corporate Members. Publisher Copyright: © 2019 Ferrata Storti Foundation.

PY - 2019/3/31

Y1 - 2019/3/31

N2 - Unlike unrelated donor registries, transplant centers lack uniform approaches to related donor assessment and deferral. To test whether related donors are at increased risk for donation-related toxicities, we conducted a prospective observational trial of 11,942 related and unrelated donors aged 18-60 years. Bone marrow (BM) was collected at 37 transplant and 78 National Marrow Donor Program centers, and peripheral blood stem cells (PBSC) were collected at 42 transplant and 87 unrelated donor centers in North America. Possible presence of medical comorbidities was verified prior to donation, and standardized pain and toxicity measures were assessed pre-donation, peri-donation, and one year following. Multivariate analyses showed similar experiences for BM collection in related and unrelated donors; however, related stem cell donors had increased risk of moderate [odds ratios (ORs) 1.42; P<0.001] and severe (OR 8.91; P<0.001) pain and toxicities (OR 1.84; P<0.001) with collection. Related stem cell donors were at increased risk of persistent toxicities (OR 1.56; P=0.021) and non-recovery from pain (OR 1.42; P=0.001) at one year. Related donors with more significant comorbidities were at especially high risk for grade 2-4 pain (OR 3.43; P<0.001) and non-recovery from toxicities (OR 3.71; P<0.001) at one year. Related donors with more significant comorbidities were at especially high risk for grade 2-4 pain (OR 3.43; P<0.001) and non-recovery from toxicities (OR 3.71; P<0.001) at one year. Related donors reporting grade ≥2 pain had significant decreases in Health-Related Quality of Life (HR-QoL) scores at one month and one year post donation (P=0.004). In conclusion, related PBSC donors with comorbidities are at increased risk for pain, toxicity, and non-recovery at one year after donation. Risk profiles described in this study should be used for donor education, planning studies to improve the related donor experience, and decisions regarding donor deferral. Registered at clinicaltrials.gov identifier: 00948636.

AB - Unlike unrelated donor registries, transplant centers lack uniform approaches to related donor assessment and deferral. To test whether related donors are at increased risk for donation-related toxicities, we conducted a prospective observational trial of 11,942 related and unrelated donors aged 18-60 years. Bone marrow (BM) was collected at 37 transplant and 78 National Marrow Donor Program centers, and peripheral blood stem cells (PBSC) were collected at 42 transplant and 87 unrelated donor centers in North America. Possible presence of medical comorbidities was verified prior to donation, and standardized pain and toxicity measures were assessed pre-donation, peri-donation, and one year following. Multivariate analyses showed similar experiences for BM collection in related and unrelated donors; however, related stem cell donors had increased risk of moderate [odds ratios (ORs) 1.42; P<0.001] and severe (OR 8.91; P<0.001) pain and toxicities (OR 1.84; P<0.001) with collection. Related stem cell donors were at increased risk of persistent toxicities (OR 1.56; P=0.021) and non-recovery from pain (OR 1.42; P=0.001) at one year. Related donors with more significant comorbidities were at especially high risk for grade 2-4 pain (OR 3.43; P<0.001) and non-recovery from toxicities (OR 3.71; P<0.001) at one year. Related donors with more significant comorbidities were at especially high risk for grade 2-4 pain (OR 3.43; P<0.001) and non-recovery from toxicities (OR 3.71; P<0.001) at one year. Related donors reporting grade ≥2 pain had significant decreases in Health-Related Quality of Life (HR-QoL) scores at one month and one year post donation (P=0.004). In conclusion, related PBSC donors with comorbidities are at increased risk for pain, toxicity, and non-recovery at one year after donation. Risk profiles described in this study should be used for donor education, planning studies to improve the related donor experience, and decisions regarding donor deferral. Registered at clinicaltrials.gov identifier: 00948636.

UR - http://www.scopus.com/inward/record.url?scp=85064008651&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85064008651&partnerID=8YFLogxK

U2 - 10.3324/haematol.2018.200121

DO - 10.3324/haematol.2018.200121

M3 - Article

C2 - 30381298

AN - SCOPUS:85064008651

SN - 0390-6078

VL - 104

SP - 844

EP - 854

JO - Haematologica

JF - Haematologica

IS - 4

ER -

Related peripheral blood stem cell donors experience more severe symptoms and less complete recovery at one year compared to unrelated donors

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