Original Safety of dendritic cell and cytokine-induced killer (DC-CIK) cell-based immunotherapy in patients with solid tumor: a retrospective study in China

Systematic assessment of adverse side effects of Adoptive T cell therapy, especially cytokine-induced killer cell and dendric cell treatment Dendritic cells-Cytokine-induced killer (DC-CIK) therapy, especially when combined with chemotherapy, has not been reported. Totally 1100 consecutive patients (2504 trail cycles) enrolled in DC-CIK treatment trials at Beijing Shijitian Hospital between August 2012 and August 2022 were retrospectively reviewed. The 370 patients (34%)/815 cycles enrolled in our trial combined with chemotherapy. In total, 548 (cases)/870 (cycles) patients experienced AEs. The AE class was mainly composed of Neurological 34 cycles (4%), Musculoskeletal 28 cycles (3%), Immunopathies 5 cycles (1%), Hematological 521 cycles (60%), 224 general dis-orders and administration site conditions cycles (26%), Gastrointestinal 209 cycles (24%), Skin 15 cycles (2%), and 119 Metabolism and Nutrition disorders cycles (14%). The AE class of gastrointestinal (vomiting, P=0.025), nutritional (anorexia, P=0.016), and hematological disorders (anemia P<0.0001, leukopenia P<0.0001) appeared in the DC-CIK treatment and were mainly correlated with chemotherapy. Multiple logistic regression analysis suggested that regardless of whether DC-CIK was combined with chemotherapy, multi-line treatment was more prone to nausea, anorexia, fatigue, anemia, and leukopenia than first-line treatment. However, correlation analysis verified that increasing the number of cycles of DC-CIK treatment alone could reduce the incidence rate of fatigue (P=0.001), anorexia (P<0.0001), and anxiety (P=0.01). Most of the adverse side effects that occurred during autologous DC-CIK treatment were associated with combined or previously applied chemotherapeutic treatment, which also indicated that autologous DC-CIK anti-tumor therapy was safe.