DC-CIK细胞联合常规化疗治疗晚期非小细胞肺癌的临床有效性与安全性分析

Clinical efficiency and safety of DC-CIK cells combined with conventional chemotherapy in treatment of advanced non small cell lung cancer

目的分析DC-CIK细胞联合常规化疗治疗晚期非小细胞肺癌（NSCLC）的临床有效性与安全性。方法选取2010年1月至2013年10月肿瘤科收治的晚期NSCLC患者81例,依据治疗方式不同,将行NP化疗联合DCCIK细胞治疗者设为观察组（40例）,行NP化疗者设为对照组（41例）。观察并记录患者的治疗效果（实体瘤的疗效评价标准）、体力状态（Karnofsky评分法）、免疫功能变化、血常规、肝肾功能、不良反应、生存等情况。结果观察组患者的总有效率为37.50%,对照组为29.27%,2组比较差异无统计学意义（χ2=1.468,P〉0.05）;疾病控制率、体力状态总提高率观察组为87.50%、90.00%高于对照组的75.61%、73.17%（χ2=5.374、10.957,P〈0.05）。截止到随访日期,观察组40例患者,死亡30例,存活10例,其中位无瘤生存期7.5个月（95%CI为5.16-8.95）,中位生存期14.5个月（95%CI为10.05-17.95）;对照组41例患者,死亡35例,6例存活,其中位无瘤生存期4.5个月（95%CI为3.17-6.92）,中位生存期11.5个月（95%CI为9.11-14.87）;Log-rank检验显示,观察组患者中位无瘤生存期长于对照组（χ2=6.557,P〈0.05）;观察组患者中位生存时间长于对照组,但差异无统计学意义（χ2=1.384,P〉0.05）。2组患者治疗前外周血T淋巴细胞CD＋3、CD＋8、CD＋56阳性百分比接近（t=1.395,P〉0.05;t=1.864,P〉0.05;t=1.647,P〉0.05）;观察组患者治疗后外周血T淋巴细胞CD＋3、CD＋8、CD＋56阳性百分比较治疗前升高（t=5.627,P〈0.05;t=5.974,P〈0.05;t=6.057,P〈0.05）;对照组治疗后外周血T淋巴细胞CD＋3、CD＋8、CD＋56阳性百分比较治疗前降低（t=1.412,P〉0.05;t=1.967,P〉0.05;t=1.754,P〉0.05）;治疗后,观察组患者外周血T淋巴细胞CD＋3、CD＋8、CD＋56阳性百分比显著高于对照组（t=12.367,P〈0.05;t=13.574,P〈0.05;t=10.324,P〈0.05）。观察组患者的发热率高于对照组χ2=6.549,P=0.032）;2组患者白细胞降低、血小板降低、脱发、消化道反应、肝功能损害、肾功能损害等不良反应发生率比较差异均无统计学意义（χ2=2.014,P〉0.05;χ2=1.247,P〉0.05;χ2=1.954,P〉0.05;χ2=1.358,P〉0.05;χ2=1.657,P〉0.05;χ2=1.028,P〉0.05）;2组患者不良反应轻微,给予对症处理后均得到控制。结论 DC-CIK细胞联合常规化疗是晚期非小细胞肺癌患者安全有效的治疗方式,可考虑推广应用。

Objective To analyze the clinical efficiency and safety of DC-CIK cells combined with conventional chemotherapy in treatment of advanced non small cell lung cancer（ NSCLC）. Methods Eighty-one patients with NSCLC who were admitted and treated in Department of Oncology of our hospital from January 2010 to October were enrolled in the study.According to different therapy modes,these patients were divided into observation group（ n = 40） and control group（ n =41）. The patients in observation group were treated by NP chemotherapy combined with DC-CIK cells,however,the patients in control group were treated by NP chemotherapy only. The therapeutic effects,performance status（ Karnofsky score）,changes of immune function,blood routine test,liver and kidney function,adverse reactions,survival status were observed and compared between two groups. Results The total effective rate in observation group and control group was 37. 50% and29. 27%,respectively,there was no significant difference between two groups（ χ2= 1. 468,P〉 0. 05）. The disease control rate and total improvement rate of physical state in observation group was 87. 50%,90. 00%,respectively,which was significantly higher than that（ 75. 61%,73. 1%,respectively） in control group（ P〈 0. 05）. Until the end of follow up,among 40 patients in observation group,30 patients died and 10 patients survived in whom the median carcinoma-free survival time was 7. 5 months,and the median survival time was 14. 5 months,however,among 41 patients in control group,35 patients died,6 patients survived in whom the median carcinoma-free survival time was 4. 5 months,the median survival time was 11. 5 months. Log-rank detection showed that the median carcinoma-free survival time in observation group was significant longer than that in control group（ χ2= 6. 557,P〈 0. 05）,moreover,the median survival time in observation group was longer than that in control group,but there was no significant difference between two groups（ χ2= 1. 384,P〈 0. 05）. Before treatment there was no significant difference in the positive percentage of CD＋3,CD＋8,CD＋56in peripheral blood T lymphocyte between two groups（ P〈 0. 05）. After treatment the positive percentage of CD＋3,CD＋8,CD＋56in observation group was significantly higher than that before treatment（ P〈 0. 05）,however the positive percentage of CD＋3,CD＋8,CD＋56in control group was significantly lower than that before treatment（ P〈 0. 05）. After treatment the positive percentage of CD＋3,CD＋8,CD＋56in observation group was significantly higher than that in control group（ P〈 0. 05）. The fever rate in observation group was significantly higher than that in control group（ χ2= 6. 549,P〈 0. 05）. There were no significant differences in incidence rates of leukopenia,thrombocytopenia,hair loss, digestive tract reaction, hepatic function impairment, renal function impairment between two groups（ P〈 0. 05）. Moreover the adverse reactions were slight in both groups. Conclusion DC-CIK cells combined with conventional chemotherapy is a safe and effective treatment manner for patients with advanced NSCLC.