| ObjectTo evaluate the safety and therapeutic effects of Cytokine-induced Killer(CIK) cells activated by RetroNectin for advanced malignant tumor.MethodsWe observed the clinical manifestation and side effects of 85 advanced malignant tumors cases in biotherapeutic department from 2007.12 to 2009.3,before and after one course of CIK treatments and during several courses of CIK treatments.We selected and analyzed the blood routine,hepatic function and renal function to evaluate the safety of CIK.We got CIK cells from the patients themselves and their lineal consanguinity(the children with blood relation and same blood types),and they were extracted from PBMCs,amplified and cultured for two weeks,then transfused to the patients;the cell count was more than 1×10~9 at a time(the cell activity was more than 95%) and one course had five times of transfusions.We selected the NSCLC patients typed by pathologic histology or cytology to ensure a more significative result which had the latter requirements:the KPS index was not less than 60,the expected survival time was more than three months,then collected the entire clinical information and excluded the unqualified cases;We regard their Loss of follow up as the censored count to make a statistical treatment.Finally we selected 52 cases and divided them into two groups:CIK group with 20 cases,chemotherapy group with 16 cases.Each of them were comparable and had no statistical differences in age,sexuality,KPS index,pathological type and TNM stage.We compared the life quality,immunologic function and the therapeutic effects two weeks before and after of the treatment.MST:CIK group and palliative group with 16 cases.A pair comparison of survival time was made between the CIK group and the simultaneous palliative cases regarded as the control group.ResultsSafety:The constitution of 85 advanced malignant tumor patients treated with CIK activated by RetroNectin was as fellow:50 cases of males and 35 cases of females with an age from 43 to 92.We transfused 142 times to the patients totally(78 autogenous and 64 xenogenic transfusions).The treatment courses were as fellow:1 cases of 7 courses,10 cases of 3 courses,31 cases of 2 courses and 43 cases of 1 course.42 cases (50%) had euphoria.17 cases(20%) had insomnia.7 cases(8%) had fever like upper respiratory tract infection and the temperature was less then 38.5℃lasted less than three days.1 cases had nausea and vomiting;1 cases had mild diarrhea which could improved after heteropathy and there were no heart,liver and kidney side effects.For example,there were no statistical differences of blood routine,liver and kidney function before and after the treatment of CIK in lung cancer patients(P＞0.05).Evaluation of treatment effect:there were no statistical differences of cellular and humoral immunity in the two groups of NSCLC patients(P＞0.05).Evaluation of life quality:there was only statistical difference of emotion in the life quality inventory before and after the treatment in chemotherapy group(P＜0.05),the patients were obviously listless after chemotherapy;we found that the patients treated by CIK often had appetite,physical activity and mind improvement,but there was no statistical difference.In the 20 cases of NSCLC treated by CIK,1 case was partial remission,10 cases stabilized and 9 cases progressed,ORR was 5%.DCR was 55%.In the 16 cases of NSCLC treated by chemotherapy,5 cases was partial remission,5 cases stabilized and 6 cases progressed,ORR was 31.25%.DCR was 62.50%.Survival time:The MST of CIK group(11.0 months) was longer than the palliative group(6.0 months),but there was no statistical differences of OS between the two groups(x~2=2.301,P=0.129).ConclusionsThe treatment of CIK cells activated by RetroNectin was simple and safe,with no obvious side effects,it could be used in clinical practice and spread.Xenogenic CIK treatment was safe and more fit for advanced malignant tumor patients.It indicated that the xenogenic CIK could improve the life quality and prolong the survival time.
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