Long-term Outcomes of Peripheral Blood Stem Cell Unrelated Donors Mobilized with Filgrastim.

ABSTRACT

Allogeneic hematopoietic cell transplantation is a life-saving procedure used to treat of a variety of devastating diseases. It requires hematopoietic stem cells collected via filgrastim mobilized peripheral blood stem cells or bone marrow harvest from volunteer unrelated donors. There is a paucity of safety data regarding donors' long-term adverse events. This prospective, observational study combined peripheral blood stem cell donors enrolled on the NMDP Investigational New Drug trial and bone marrow donors between July 1, 1999, and September 30, 2015. The primary objective was to describe the long-term incidence of myeloid malignancies. Secondary objectives included describing the long-term incidence of lymphoid malignancies, non-hematologic malignancies, autoimmune disorders, and thrombotic events. 21643 donors (14530 peripheral blood stem cells and 7123 bone marrow) were included. The incidence rate of myeloid disorders per 100000 person years in donors of peripheral blood stem cells was 2.53 (95% CI 0.82-7.84) and in donors of bone marrow it was 4.13 (95% CI 1.33-12.8). The incidence rate ratio of peripheral blood stem cells /bone marrow donors was 0.61 (95% CI 0.12-3.03; p=0.55). The incidence of other malignancies, autoimmunity, and thrombosis did not differ between donor types. This comprehensive study of long-term effects of filgrastim in unrelated donors of peripheral blood stem cells provides strong evidence that donors who receive filgrastim are not at increased risk of these events compared to bone marrow donors. It also provides reassurance to current donors undergoing stem cell mobilization as well as individuals considering joining stem cell registries such as NMDP.