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

Abstract 366 Background: 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. Donors and Methods: 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. Results: 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. Conclusion: 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). Disclosures: Off Label Use: Use of G-CSF under IND to mobilize CD34+ stems cells in healthy unrelated NMDP PBSC donors.