Abstract

19533 Healthy allogeneic donors, who were mobilized with G-CSF and underwent hemopoietic peripheral cells (HPC-A) collection at our Institution, were enrolled in a short- and long-term surveillance protocol for a 10 year period. To date, 175 donors have been assessed with a median follow-up of 56 months (1–147); for 71 subjects, the follow-up is > 60 months and for 20 subjects is > 96 months. Healthy donors received G-CSF at a median dose of 9.8 μg/kg (range 7–15). Bone pain was reported as the most common adverse event (70.2 % of donors). Common associated symptoms included fatigue (16.4 %), fevers (5 %), headache (26.3 %), nausea (12.9%), insomnia (16.4 %). Spleen size increased in 4.1 % of donors (> 2 cm exceeding the marginal cost at physical examination). All donors experienced side effect resolution within 2–4 days of G-CSF discontinuation. Leukocyte mean peak values were 49 x 109/L and the nadir of platelet counts reached mean values of 92 x 109/L and; however, such a decrease was not complicated by bleeding manifestations. Leukocyte and platelet counts returned to normal values in about one week. No vascular disorders and cardiac disease occurred. Long-term observation included adverse events in donors after 30 days from HPC-A mobilization and any neoplastic or not disease developed any time post donation. 4 donors showed persistent, slight leucocytopenia until the second month, with recovery in the fourth month of follow-up. 18 donors showed an AST and ALT result 2.5 times the upper limit of normal until the second months of follow-up. Transit ischemic attack occurred in 1 donor, (39 months post after donation). 1 autoimmune event has been reported 28 months post-G-CSF (anckylosing spondylitis); 1 donor with a history of chronic obstructive pulmonary disease developed a secondary polyglobulia (50 months post-G-CSF); 1 donor developed a gastric tumor, 19 months post-donation. No hematological malignancy was observed. In conclusion, our main findings are that the primary toxicity of G-CSF administration is bone pain and that no cardiovascular events was related to the donation. With a median follow-up near to 5 years, no hematological disease was observed in our cohort of donors. No significant financial relationships to disclose.

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