1. ¹UO Ematologia con Trapianto, Azienda Ospedaliera 'Bianchi-Melacrino-Morelli', Reggio Calabria, Italy
2. ²UO Medicina Trasfusionale, Azienda Ospedaliera 'Bianchi-Melacrino-Morelli', Reggio Calabria, Italy

Correspondence: Dr M Martino, UO Ematologia con Trapianto, Azienda Ospedaliera 'Bianchi-Melacrino-Morelli', 89100 Reggio Calabria, Italy. E-mail: maxmartino@tele2.it

Received 26 September 2008; Revised 27 November 2008; Accepted 12 December 2008; Published online 2 February 2009.

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 g/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.