ObjectiveTo explore the clinical significance of serum procalcitonin (PCT) concentration in the occurrence of chimeric antigen receptor T cell (CAR-T) immunotherapy related cytokine release syndrome (CRS) among patients with hematologic malignancies.
MethodsFrom June 2016 to June 2018, a total of 40 patients with hematological malignancies who hospitalized in the Department of Hematology, Affiliated Hospital of Xuzhou Medical University were selected as the research objects. The median age of patients was 37 years (2-72 years) old. Among them, there were 23 male patients and 17 females. All patients were treated with CAR-T immunotherapy, and their effect of treatment and the occurrence of CAR-T related CRS were observed, by retrospective analysis method. The Mann-WhitneyUtest was used to compare the serum PCT concentration among different patients or the same patient at different observation time.The correlation between serum PCT concentration and severity of CAR-T related CRS was analyzed by Spearman rank correlation analysis. The serum PCT concentration in predicting the occurrence risk of CAR-T related severe CRS was determined by the receiver operating characteristic curve (ROC) method, the ROC-area under the curve (AUC) was calculated, and the maximum Youden index principle was used to determine the cut-off value.The procedure followed in this study was in accordance with the ethical standards established by the Human Experimental Committee of the Affiliated Hospital of Xuzhou Medical University, and was approved by the committee (Approval No.XYFY2016-KL002-01). All subjects or their guardians signed informed consents for this clinical research.
Results① After CAR-T infusion, there were 24 patients (60%) achieved remission, and 16 (40%) patients did not respond.There were 33 cases (82.5%) with different degrees of CAR-T related CRS, and 7 cases without it.② The median serum PCT concentration of patients with and without CAR-T related CRS were 1.62 ng/mL (0.73-8.95 ng/mL) and 0.14 ng/mL (0.13-0.40 ng/mL), and the difference was statistically significant (Z=3.242,P=0.001). ③ Among 33 CAR-T related CRS patients, the serum PCT concentrations before and after CRS were 0.135 ng/mL (0.103-0.260 ng/mL) and 1.320 ng/mL (0.420-6.450 ng/mL), respectively, and the difference was also statistically significant (Z=5.136,P<0 .001). ④ the serum pct concentration of 33 crs patients was positively correlated with their severity of car-t related crs (r=0.678,P<0 .001). ⑤the roc-auc of serum pct concentration predicting car-t related severe crs was 0.850 (95%CI: 0.660-0.009,P=0.003), the cut-off value was 3.19 ng/mL, the sensitivity was 87.5%, the specificity was 78.7%.
ConclusionsSerum PCT concentration could be used as a predictor of CAR-T related CRS in patients with hematological malignancies.Serum PCT concentration has certain clinical value in predicting severe CRS.
