自体CIK细胞治疗联合DP方案一线化疗治疗晚期肺腺癌临床研究

Clinical Effects of Autologous Cytokine-induced Killer Cells combined with DP Regimen First Line Chemotherapy in Patients with Advanced Lung Adenocarcinoma

目的:观察自体CIK细胞联合多西他赛+顺铂(DP)方案一线化疗治疗晚期肺腺癌的临床疗效。方法:病理明确诊断的100例ⅢB期和Ⅳ期的肺腺癌患者,按照随机数字表法1:1随机分成实验组(DP联合CIK)和对照组(单纯DP化疗)。对两组T细胞亚群、疾病控制率(IDCR)、中位总生存期(MST)、疾病无进展生存期(PFS)进行比较。结果:实验组的疾病控制率(DCR)为86%(43/50),化疗组的DCR为60%(30/50),P<0.005。实验组T细胞亚群CD3^+,CD3^+CD8^+,CD3^+CD56^+在治疗后较治疗前明显升高(P<0.05);对照组CD3^+,CD3^+CD56^+在治疗后较治疗前明显降低,差异有统计学意义(P<0.05)。两组的MST分别为15.20个月(95%CI,11.82个月~18.58个月)和10.50个月(95%CI,8.08个月~12.92个月),差异有统计学意义(P=0.02);PFS分别为6.30个月(95%CI,4.45个月~8.15个月)和5.6个月(95%cI,4.91个月~6.29个月),差异有统计学意义(P=0.013)。结论:CIK联合DP方案治疗晚期肺腺癌,可以调节患者的免疫功能,延长患者的疾病无进展生存期和总生存期,同时未见明显不良反应。

Objective： To evaluate the clinical efficacy of autologous cytokine-induced killer cells combined with DP regimen （docetaxel plus cisplatin）first line chemotherapy in patients with lung adenocarcinoma. Methods： One hundred advanced lung adeno- carcinoma patients diagnosed pathologically were randomly divided into two groups, experimental group （DP combined with CIK） and control group（ DP chemotherapy alone）. The cellular immune function, disease control rate （DCR）, progression free survival （PFS） and median survival time（MST） were compared between the two groups. Results： The DCRs were 86% （43/50） and 60% （30/50） in experimental group and control group respectively （P 〈 0. 005 ）. After treatment, CD3 ＋ , CD3 ＋ CD8 ＋ , CD3 ＋ CD56 ＋ T cells of the experimental group increased significantly compared with that of the pre-therapy level （ P 〈 0.05 ）. In the control group, CD3 ~ , CD3 ~ CD56 ＋ T cells decreased after therapy compared to the pre-therapy level （ P 〈 0. 05 ）, these was statistically significant differ- ence. The MST were 15.20 months（95% CI, 11.82 ~ 18.58 months） and 10. 50 months（95% CI, 8. 08 - 12. 92 months） of experi- mental group and control group respectively（P =0. 020） ;The PFS were 6.30months（95% CI,4.45 - 8.15 months） and 5.6 months （95 % CI, 4. 91 ~ 6. 29 months） of experimental group and control group respectively （ P = 0. 013 ）. Conclusion ： CIK combined with DP chemotherapy could enhance the patients＇ immune function, extend the progression-free survival and the overall survival time of pa- tients with advanced lung adenocarcinoma without obviously adverse reactions.