Higher Age (≥60 Years) Increases the Risk for Adverse Events during Autologous Hematopoietic Stem Cell Transplantation

SIMPLE SUMMARY: Autologous hematopoietic stem cell transplantation (autoHSCT) is a highly regulated procedure for the treatment of various diseases. In a retrospective, observational study from adult patients treated with autoHSCT during the years 2016–2019, we evaluated the occurrence and severity of adverse events (AEs) related to each step from collection to infusion and investigated whether certain factors correlated with the occurrence and number of AEs. Of the 449 patients, 19.6% had AEs, and only 6.0% experienced adverse reactions (ARs); 25.8% of the AEs were serious and 57.5% were potentially serious. Larger leukapheresis volumes, lower numbers of collected CD34+ cells, and larger transplant volumes significantly correlated with the occurrence and number of AEs. Moreover, patients over 60 years experienced significantly more AEs. By preventing AEs related to quality and procedure, potentially serious AEs could be reduced by 36.7%. These results highlight potential steps for optimization of the autoHSCT procedure, especially in elderly patients. ABSTRACT: Autologous hematopoietic stem cell transplantation (autoHSCT) is a standard of care for patients with hemato-oncologic diseases. This procedure is highly regulated, and a quality assurance system needs to be in place. Deviations from defined processes and outcomes are reported as adverse events (AEs: any untoward medical occurrence temporally associated with an intervention that may or may not have a causal relationship), including adverse reactions (ARs: a response to a medicinal product which is noxious and unintended). Only a few reports on AEs cover the procedure of autoHSCT from collection until infusion. Our aim was to investigate the occurrence and severity of AEs in a large data set of patients who were treated by autoHSCT. In this retrospective, observational, single-center study on 449 adult patients during the years 2016–2019, AEs occurred in 19.6% of the patients. However, only 6.0% of patients had ARs, which is a low rate compared to the percentages (13.5–56.9%) found in other studies; 25.8% of the AEs were serious and 57.5% were potentially serious. Larger leukapheresis volumes, lower numbers of collected CD34+ cells and larger transplant volumes significantly correlated with the occurrence and number of AEs. Importantly, we found more AEs in patients >60 years (see graphical abstract). By preventing potentially serious AEs of quality and procedural issues, AEs could be reduced by 36.7%. Our results provide a broad view on AEs and point out steps and parameters for the potential optimization of the autoHSCT procedure, especially in elderly patients.