Health-Related Quality-of-Life Among Adult Matched Unrelated Stem Cell Donors: A Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Randomized Trial of Marrow Versus PBSC Donation

In recent years, donor hematopoietic stem cells have been increasingly collected by leukapheresis using the PBSC procedure in GCSF-stimulated donors as an alternative to the traditional surgical marrow collection process. However, the relative medical safety and health-related quality-of-life (HRQoL) impact of the two procedures on donors have not been systematically compared. In 2004 the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) initiated a randomized trial that included evaluation of potential medical and HRQoL differences between BM and PBSC donors. Data collection for the trial is complete for the time points shortly pre-and post-donation.

The goals of the analyses were to examine (a) pre- and post-donation differences on key variables by donation type, and (b) the association of pre-donation variables with donor recovery. Participants included 273 adult matched unrelated BM (n=131) and PBSC (n=142) donors who donated at U.S. centers between July, 2004 and October, 2009 and completed pre-, 48 hours post-, and weekly post-donation telephone interviews until fully recovered defined as three consecutive symptom-free weeks. Basic socio-demographics, physical and mental health status, and donation-related perceptions were self-reported by donors and key clinical variables were collected from donor centers. Odds-ratios for dichotomous variables and t-tests for continuous variables were used to examine differences in pre- and post-donation variables by donation type and to examine the potential effects of pre-donation variables on recovery at 8-weeks post-donation.

At pre-donation, BM donors were significantly more likely to be married (OR=1.82; 1.11–2.94), employed (OR=2.98; 1.05–8.44), and to feel prepared for donation (OR=1.89; 1.01–3.45) than PBSC donors. At 48-hours post-donation, BM donors reported significantly more physical effects of donation including greater intensity (t=3.11; p<.01) and duration (t=4.77; p<.001) of pain, and a greater number of side-effects including bleeding (OR=6.67; 3.33–12.50) and pain at the needle sites used to harvest the component (OR=4.17; 2.38–7.69), use of prescription medications (OR=9.09; 5.00–16.67), and failure to return to work (OR=6.67; 3.45–14.29) and leisure activities (OR=6.46; 3.52–11.86) due to the donation. Bone marrow donors also reported more psychological benefit from donation than did PBSC donors (OR=1.72; 1.06–2.86). At 48-hours post-donation, the two groups did not differ on mood-related variables, concern about longer-term health as a result of the donation, or satisfaction with the donation decision. At 8-weeks post-donation, BM donors were slightly but not significantly less likely than PBSC donors to be fully recovered. Pre-donation variables that were significantly associated with failure to achieve full recovery at 8-weeks included female gender (OR=1.85; 1.10–3.13), higher levels of pre-donation mood (t=4.91; p<.001) and emotional (t=3.87; p<.001) disturbance, more pre-donation medical and family concerns about the donation procedure including concerns about pain (OR=9.62; 1.34–3.72) and missed time from work (OR=2.16; 1.30–3.59), and feeling less prepared for donation (OR=3.28; 1.72–6.25). Clinical variables including donor height, weight, and adverse event occurrence were not associated with recovery.

These findings highlight the important role of pre-donation psychological variables in the overall stem cell donation experience. The association of pre-donation mood and emotional variables, concerns about the donation procedure, and self-reported lower preparedness for the donation with recovery 8 weeks after donation suggests that the management of adult unrelated donors could be expanded to include direct assessment and mitigation of pre-donation HRQoL deficits and concerns.

This research received funding via CTN (NIH-NHLBI and NCI, Navy, HRSA and NMDP).

Off Label Use: Use of G-CSF under IND to mobilize CD34+ stems cells in healthy unrelated NMDP PBSC donors.