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

Pulsipher, Michael A.; Chitphakdithai, Pintip; Logan, Brent R.; Shaw, Bronwen E.; Wingard, John R.; Lazarus, Hillard M.; Waller, Edmund K.; Seftel, Matthew D.; Stroncek, David F.; López, Alejandra; Maharaj, Dipnarine; Hematti, Peiman; O’Donnell, Paul V.; Loren, Alison W.; Leitman, Susan F.; Anderlini, Paolo; Goldstein, Steven C.; Levine, John E.; Navarro, Willis H.; Miller, John P.; Confer, Dennis L.

doi:10.1182/blood-2012-03-417667

Cited by 126 publications

(141 citation statements)

References 24 publications

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“…The incidence of SP in our study is consistent with a 27.0 % incidence in the placebo group of a randomized study of naproxen vs. placebo (4), using a similar definition of severe pain as a score of 5 on the WPS but without adjustment for baseline pain. In contrast, a recent study of 2408 first-time stem cell donors receiving high-dose G-CSF revealed that over 80% of donors experienced bone pain by day 4 of therapy, but only 9% characterized their bone pain as severe (24). Similar to our own results, the stem cell donor cohort reported bone pain most often in the axial skeleton, especially the back, hips, and pelvis (24).…”

Section: Discussionmentioning

confidence: 94%

“…In contrast, a recent study of 2408 first-time stem cell donors receiving high-dose G-CSF revealed that over 80% of donors experienced bone pain by day 4 of therapy, but only 9% characterized their bone pain as severe (24). Similar to our own results, the stem cell donor cohort reported bone pain most often in the axial skeleton, especially the back, hips, and pelvis (24). …”

Section: Discussionmentioning

confidence: 94%

“…An exploratory analysis demonstrating that 90.9% of patients receiving taxane-containing chemotherapy benefited from loratadine prophylaxis compared to only 27.3% in the placebo arm (p = 0.008) may in part reflect effective loratadine prophylaxis of taxane-induced pain. (5, 24)…”

Section: Discussionmentioning

confidence: 99%

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Randomized phase II study of loratadine for the prevention of bone pain caused by pegfilgrastim

Moukharskaya¹,

Abrams

Ashikaga

et al. 2016

Support Care Cancer

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Purpose Bone pain is a common side-effect of pegfilgrastim and can interfere with quality of life and treatment adherence. This study i nvestigated the impact of antihistamine prophylaxis on pegfilgrastim-induced bone pain. Methods This is a two stage enrichment trial design. Patients receiving an initial dose of pegfilgrastim after chemotherapy were enrolled into the observation stage (OBS). Those who developed significant back or leg bone pain (SP) were enrolled into the treatment stage (TRT) and randomized to daily loratadine 10 mg or placebo for 7 days. SP was defined by Brief Pain Inventory as back or leg pain score ≥ 5 and a 2 point increase after pegfilgrastim. The primary end-point of TRT was reduction of worst back or leg bone pain with loratadine, defined as 2 point decrease after treatment compared to OBS. Results 213 patients were included in the final analysis. Incidence of SP was 30.5%. The SP subset had a worse overall Functional Assessment of Cancer Therapy – Bone Pain score (33.9 vs. 51.7, p < 0.001) and a higher mean white blood cell count (15.4 vs. 8.4 K/cm3, p = 0.013) following pegfilgrastim than those without SP. 46 patients were randomized in the TRT. Benefit was 77.3% with loratadine and 62.5% with placebo (p = 0.35). Baseline NSAID use was documented in 4 patients (18.2%) in loratadine arm and 2 patients (8.3%) in placebo arm, with baseline non-NSAID use documented in 5 (22.7%) and 6 (25%) patients respectively. Eight additional patients used NSAIDS by day 8 compared to day 1 (6 in the loratadine and 2 in the placebo arm). A total of 6 additional patients used non-NSAIDS by day 8 compared to day 1 (4 in the loratadine and 2 in the placebo arm). Conclusions Administration of prophylactic loratadine does not decrease the incidence of severe bone pain or improve quality of life in a high-risk patient population.

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Section: Discussionmentioning

confidence: 94%

Section: Discussionmentioning

confidence: 94%

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Randomized phase II study of loratadine for the prevention of bone pain caused by pegfilgrastim

Moukharskaya¹,

Abrams

Ashikaga

et al. 2016

Support Care Cancer

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“…Recovery usually takes 1-2 weeks, although a small percentage (o 2%) of donors will suffer lower back pain for longer and o 1% may have longstanding problems with pain. 14 Risks of PBSC and lymphocyte collection Over the past two decades, PBSC or progenitor cell leukapheresis has become the preferred route of HSC collection for many indications, accounting for~70% of unrelated adult donations. 3 Donors have subcutaneous injections of G-CSF for 4-5 days, which mobilizes HSC into the circulation.…”

Section: Risks Of Donation: Donor Safetymentioning

confidence: 99%

Unrelated adult stem cell donor medical suitability: recommendations from the World Marrow Donor Association Clinical Working Group Committee

Lown

Philippe

Navarro

et al. 2014

Bone Marrow Transplant

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“…For approximately one-third, the HSC donor is also a child, 1 typically a healthy sibling who undergoes BM harvest or large volume apheresis for collection of peripheral blood stem cells. Recognizing that HSC donors face risks [2][3][4][5] (Table 1) without the potential for direct medical benefit, the American Academy of Pediatrics recently published guidelines specifying when minors may ethically serve as HSC donors for a standard (nonresearch) transplant. 6 This raises the need for guidance on when minors may donate HSCs in the research setting.…”

Section: Introductionmentioning

confidence: 99%

Children as hematopoietic cell donors in research: when is it approvable?

Shah

Wayne

Grady

et al. 2014

Bone Marrow Transplant

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With increasing frequency, allogeneic hematopoietic cell transplantation involving children is being performed in the research setting. Allogeneic hematopoietic cell transplantation, however, cannot be performed without a hematopoietic stem cell (HSC) donor. This donor is often a sibling of the recipient and may also be a child. In such circumstances, it is unclear whether or how the federal regulations for pediatric research apply to the minor donors. This introductory paper reviews the issues to be considered while evaluating studies that use HSCs obtained from minor donors and identifies areas where further research is needed. In the era of increasing applicability for donor-derived cellular therapies, we provide a suggested framework for determining when minor donors qualify as human research subjects and when their participation can be approved under the federal regulations.

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

Cited by 126 publications

References 24 publications

Randomized phase II study of loratadine for the prevention of bone pain caused by pegfilgrastim

Randomized phase II study of loratadine for the prevention of bone pain caused by pegfilgrastim

Unrelated adult stem cell donor medical suitability: recommendations from the World Marrow Donor Association Clinical Working Group Committee

Children as hematopoietic cell donors in research: when is it approvable?

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