Mobilization of hematopoietic stem cells with lenograstim in healthy donors: efficacy and safety analysis according to donor age

Abstract

We reviewed and analyzed safety and efficacy data after mobilization with granulocyte colony-stimulating factor (G-CSF) according to healthy donor's (HDs) age as follows: <50 years (HDs-1, n = 161), aged 50 to 59 years (HDs-2, n = 62), and ≥60 years or over (HDs-3, n = 23). Two hundred forty-six HDs were evaluated, and their characteristics were well balanced among age groups: most were male, siblings, and HLA matched. According to age group, the median numbers of CD34(+) cells in the peripheral blood for HDs-1, HDs-2, and HDs-3 were, respectively, 44.5, 34.5, and 26 (HDs-1 versus HDs-2, P = .002; HDs-1 versus HDs-3, P = .036; HDs-2 versus HDs-3, P = n.s.) at day 4 and 65.5, 58, and 46 (HDs-1 versus HDs-2, P = .039; HDs-1 versus HDs-3, P = .002; HDs-2 versus HDs-3, P = n.s.) at day 5. With a median apheresis session of 1, the number of CD34(+) cells/kg recipient body weight collected was not significantly different (6.4 in HDs-1, 6.0 in HDs-2, and 5.7 in HDs-3, P = n.s.). Short- and long-term safety did not differ among age groups. Bone pain was reported as the most frequent short-term adverse event (76.5%). After a median follow-up of 7.8 years, the observed rate of solid tumors, hematological malignancies, and cardiovascular and autoimmune events was similar to the expected incidence for these diseases in Western countries. These results show that G-CSF is effective in the mobilization of older HDs. Moreover, our data contribute to the growing body of evidence in support of the long-term safety of G-CSF for allogeneic donor stem cell mobilization also for elderly HDs.

Keywords: Efficacy; G-CSF; Healthy donors; Hematopoietic stem cells; Mobilization.