Three to six year follow-up of normal donors who received recombinant human granulocyte colony-stimulating factor

Abstract

Summary:One hundred and one donors who had received filgrastim (rhG-CSF) for the purpose of donating either granulocytes or peripheral blood stem cells (PBSC) for their relatives more than 3 years ago were contacted. All donors had received daily rhG-CSF at a median dose of 16 g/kg/day (range 3-16) for a median of 6 days (range 3-15 days). All collection procedures were completed and short-term side-effects of rhG-CSF were mild in the majority of the donors. At a median time interval of 43.13 months (range 35-73), the donors were contacted to assess whether adverse effects related to rhG-CSF administration had occurred. Prior to rhG-CSF two donors had cancer, one had a myocardial infarction, one was hepatitis C virus positive, one had a history of sinusitis, one had Graves' disease and two had arterial hypertension. None worsened with the rhG-CSF administration but the donor with a history of infarction had an episode of angina following apheresis, and the donor with Graves' disease had a stroke 15 months after rhG-CSF. Two pregnancies occurred after the rhG-CSF administration and one donor was 2-3 weeks pregnant during rhG-CSF treatment. Three pregnancies resulted in two normal births and one in a spontaneous abortion of a pregnancy which occurred more than 2 years following rhG-CSF. In the time following rhG-CSF administration two donors developed cancer (breast and prostate cancer) at a follow-up of 70 and 11 months, respectively. One donor developed lymphadenopathy 38 months after the rhG-CSF, which spontaneously

Regeneration, health status and quality of life after rhG-CSF-stimulated stem cell collection in healthy donors: a cross-sectional study

“…The laboratory results of our donors during the early post-donation course regarding WBC and platelet counts were in line with earlier reports. 1,[16][17][18][19]29 Our questionnaire included the history of intercurrent diseases, surgical interventions and the need for new medications in the post-donation period. Most events occurred in donors who were 50 years of age and older at the time of query.…”

“…1 Since then, cytokine-mobilized PBPCs collected from healthy sibling or unrelated donors are increasingly used as stem-cell source in the allogeneic setting. 2 PBPCs have been shown to be superior to BMderived stem cells during the early post transplant course.…”

“…12 Until now, there is no convincing evidence that rhG-CSF administration leads to an increased risk to develop hematological malignancies in healthy individuals. 13 The aim of our study was (1) to assess the short-term side effects of rhG-CSF administration and PBPC collection in our sibling donor population by monitoring of medical events and recording laboratory data on days 1, 7, 30 and 100; (2) to evaluate the influence of rhG-CSF and PBPC donation on health status and quality of life (QoL) assessed by a questionnaire in a cross-sectional study and (3) to investigate the long-term safety profile of rhG-CSF by evaluation of retrospective questions on intercurrent events, such as infections, occurrence of new diseases and need for new medications.…”

Uniform examination of stem cell donors

“…Long-term increased risks of PBSC donation have not been identified [36,37], but remain of concern, in particular development of haematological malignancy, solid tumours, myelodysplasia, vascular and autoimmune diseases. In the retrospective EBMT study, a follow-up questionnaire revealed that 20 out of 51 000 donors had developed a haematological malignancy between 4 months and 12 years post-donation (15 related donors and 5 not reported) [30].…”

“…In the retrospective EBMT study, a follow-up questionnaire revealed that 20 out of 51 000 donors had developed a haematological malignancy between 4 months and 12 years post-donation (15 related donors and 5 not reported) [30]. The large unrelated donor registries now collect long-term outcome data of donors in a systematic prospective manner [33][34][35][36][37].…”