Adverse Events In Malignant Tumor Sufferers For Immunotherapy With Autologous Cytokine-induced Killer Cells And Clinical Efficacy In Patients With Renal Cell Carcinoma After Nephrectomy

Objective:1.To analysis the adverse evens(AEs) of autologous cytokine-induced killer (CIK) cells for adoptive immunotherapy in malignant tumor sufferers and to identify the risk facts associated with these AEs.2.To evaluate the efficacy and safety of autologous cytokine-induced killer (CIK) cells in patients with renal cell carcinoma (RCC) after nephrectomy.Methods:The AEs of 730 malignant tumors patients who received a total of 3340 transfusions treated with CIK immunotherapy from March 2008 to October 2012 were studied according to National Cancer Institute Common Terminology Criteria, we retrospectively analyzed the clinical features, abnormal examination results, countermeasures and the risk factors.20 patients between January 2009 and April 2010 diagnosed with RCC after nephrectomy were randomly divided into two groups, a CIK cell treatment group and a control group.The endpoint was progression-free survival (PFS) evaluated by Kaplan-Meier analyses. We detected the Peripheral lymphocyte subsets of CD3+,CD4+T cells, ratio of CD4+/CD8+before and after CIK cell transfusion.Results:1.The common AEs associated with cell infusion were transient fever(1.98%), fatigue(1.08%),gastrointestinal system discomfort(0.39%), rash(0.18%), arthralgia(O. 15%),the grade were Ⅰ-Ⅱ; tumor lysis syndrome(0.03%), anaphylaxis (0.03%), systemic inflammatory response syndrome reaction (0.15%),the grade were Ⅲ. The total incidence of AEs was 4.28%.The severe but rare AEs included severe anaphylactoid reaction and tumor lysis syndrome and SIRS,no transfusion-associated death was noticed.The mainly relative risk factors for AEs were transfer cycles and clinical stages.2.20 RCC patients after radical nephrectomy were all alive during the course of followup, The median PFS in CIK cell treatment group was significantly longer than that in control group (PFS,32.2 months versus 21.6 months; log-rank, p= 0.032), and there are no statistically significant differences between two groups in OS (log-rank, p= 0.214). CD3+, CD4+ cells and ratio of CD4+/CD8+ levels increased after CIK cell transfusion.Conclusion:1.This study is a single-centre and larger-sample research,revealing that autologous CIK cells immunotherapy is well-tolerated and fairly safety treatment modality.No lethal AEs were observed even in few patients with rare severe events.2. CIK cells can exert their cytotoxic activity and control tumor growth for the treatment of RCC after nephrectomy. Furthermore, CIK cells regulate and improve the immune function of patients with cancer.