Adverse events among 2408 unrelated donors of peripheral blood stem cells: results of a prospective trial from the National Marrow Donor Program

Abstract

Limited data are available describing donor adverse events (AEs) associated with filgrastim mobilized peripheral blood stem cell (PBSC) collections in unrelated volunteers. We report results in 2408 unrelated PBSC donors prospectively evaluated by the National Marrow Donor Program (NMDP) between 1999 and 2004. Female donors had higher rates of AEs, requiring central line placement more often (17% vs 4%, P< .001), experiencing more apheresis-related AEs (20% vs 7%, P< .001), more bone pain (odds ratio [OR]=1.49), and higher rates of grades II-IV and III-IV CALGB AEs (OR=2.22 and 2.32). Obese donors experienced more bone pain (obese vs normal, OR=1.73) and heavy donors had higher rates of CALGB toxicities (>95 kg vs <70 kg, OR=1.49). Six percent of donors experienced grade III-IV CALGB toxicities and 0.6% experienced toxicities that were considered serious and unexpected. Complete recovery is universal, however, and no late AEs attributable to donation have been identified. In conclusion, PBSC collection in unrelated donors is generally safe, but nearly all donors will experience bone pain, 1 in 4 will have significant headache, nausea, or citrate toxicity, and a small percentage will experience serious short-term adverse events. In addition, women and larger donors are at higher risk for donation-related AEs.

Figure 1

Incidence of bone pain. Pain symptoms were evaluated before administration of filgrastim each day and at each follow-up after donation. (A) Percentage of PBSC donors who experienced bone pain. (B) Site of bone pain frequency on Day 4. (C) Frequency of highest severity of bone pain during mobilization and collection.

Figure 2

Assessment of donor symptoms using the Abbreviated CALGB Toxicity Criteria. Abbreviated CALGB Toxicity Criteria were evaluated before administration of filgrastim each day. (A) Frequency of highest CALGB score reported by PBSC donors during mobilization and collection. (B) Frequency of highest CALGB score across all symptoms reported by PBSC donors during mobilization and collection.

Figure 3

Adverse events associated with access and apheresis. (A) Percentage of PBSC donors who required central venous access, by sex. (B) Percentage of PBSC donors who reported adverse events as a result of donation, by sex.

Figure 4

Box and whiskers plot of blood counts showing the maximum, upper quartile, median, lower quartile, and minimum values obtained from PBSC donors on the first day of injection (Day 1), before and after donation (Day 5 before and Day 5 after), and during follow-up after donation. (A) Donor white blood cell counts. (B) Donor platelet counts. (C) Donor hemoglobin levels, by sex.

Figure 5

Frequencies of PBSC donor's highest ECOG score during mobilization and collection and of donor's ECOG score at 1 week after donation. The donor's ECOG Performance Status was rated before administration of filgrastim each day and at each follow-up after donation.