Lower risk for serious adverse events and no increased risk for cancer after PBSC vs BM donation

Abstract

We compared serious early and late events experienced by 2726 bone marrow (BM) and 6768 peripheral blood stem cell (PBSC) donors who underwent collection of PBSC or BM between 2004 and 2009 as part of a prospective study through the National Marrow Donor Program. Standardized FDA definitions for serious adverse events (SAEs) were used, and all events were reviewed by an independent physician panel. BM donors had an increased risk for SAEs (2.38% for BM vs 0.56% for PBSC; odds ratio [OR], 4.13; P < .001), and women were twice as likely to experience an SAE (OR for men, 0.50; P = .005). Restricting the analysis to life-threatening, unexpected, or chronic/disabling events, BM donors maintained an increased risk for SAEs (0.99% for BM vs 0.31% for PBSC; OR, 3.20; P < .001). Notably, the incidence of cancer, autoimmune illness, and thrombosis after donation was similar in BM vs PBSC donors. In addition, cancer incidence in PBSC donors was less than that reported in the general population (Surveillance, Epidemiology, and End Results Program database). In conclusion, SAEs after donation are rare but more often occurred in BM donors and women. In addition, there was no evidence of increased risk for cancer, autoimmune illness, and stroke in donors receiving granulocyte colony-stimulating factor during this period of observation.

Figure 1

Classification of SAEs experienced by BM and PBSC donors. (A) SAEs by category. The number above the bar indicates the number of SAEs in that category. (B) SAEs by proximal cause.

Figure 2

Risk of cancer, autoimmunity, and thrombosis in G-CSF–treated PBSC donors vs BM donors. (A) Incidence of reported cancer after donation (excluding nonnelanoma skin cancer). (B) Incidence of reported nonmelanoma skin cancer after donation. (C) Incidence of reported autoimmunity after donation. (D) Incidence of reported thrombosis after donation.