title: Short and long-term safety of lenograstim administration in healthy peripheral haematopoietic progenitor cell donors: a single centre experience.
abstract: Healthy donors (HDs) who were mobilized using lenograstim (LENO) and who were undergoing peripheral haematopoietic progenitor cell collection with apheresis (HPC-A) were enrolled in a surveillance protocol. In all, 184 HDs have been assessed with a median follow-up of 62 months (range 2-155). HDs received LENO at a median dose of 10 microg/kg (range 5-15). Bone pain was reported as the most frequent short-term adverse event (71.2%). Other commonly observed short-term symptoms included fatigue (19.0%), fever (5.4%), headache (27.7%), nausea (12.0%) and insomnia (22.3%). Spleen size increased in 4.3% of the donors. No vascular disorders or cardiac disease occurred. Long-term follow-up included monitoring of adverse events, neoplastic disease or other pathologies. Transit ischaemic attack occurred in one donor (39 months post-donation). One autoimmune event was reported at 28 months post-recombinant human granulocyte (rhG)-CSF (ankylosing spondylitis); one donor with a history of chronic obstructive pulmonary disease developed secondary polyglobulia (50 months post-rhG-CSF). One donor was diagnosed with lung cancer at 19 months post-donation. No haematological disease was observed. In conclusion, the short-term safety appears to be verified, whereas, although the study identified no increased risks of malignancy among HDs who received rhG-CSF, long-term safety requires more complete data sets, especially a longer follow-up and a larger number of HDs.
authors.affiliation: UO Ematologia con Trapianto, Azienda Ospedaliera 'Bianchi-Melacrino-Morelli', Reggio Calabria, Italy. maxmartino@tele2.it
authors.forename: M
authors.initials: M
authors.lastname: Martino
authors.forename: G
authors.initials: G
authors.lastname: Console
authors.forename: A
authors.initials: A
authors.lastname: Dattola
authors.forename: I
authors.initials: I
authors.lastname: Callea
authors.forename: G
authors.initials: G
authors.lastname: Messina
authors.forename: T
authors.initials: T
authors.lastname: Moscato
authors.forename: E
authors.initials: E
authors.lastname: Massara
authors.forename: G
authors.initials: G
authors.lastname: Irrera
authors.forename: R
authors.initials: R
authors.lastname: Fedele
authors.forename: A
authors.initials: A
authors.lastname: Gervasi
authors.forename: G
authors.initials: G
authors.lastname: Bresolin
authors.forename: P
authors.initials: P
authors.lastname: Iacopino
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects*; D000293:Adolescent; D000328:Adult; D000368:Aged; D001781:Blood Component Removal / Q000379:methods; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects*; D019650:Hematopoietic Stem Cell Mobilization / Q000009:adverse effects* / Q000379:methods; D006801:Humans; D000078224:Lenograstim; D008875:Middle Aged; D036102:Peripheral Blood Stem Cell Transplantation; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D014019:Tissue Donors; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000078224:Lenograstim