Wu Changping, Jiang Jingting, Shi Liangrong, Xu Ning
The Third Affiliated Hospital of Suzhou University, Changzhou 213003, PR China.
Anticancer Res. 2008 Nov-Dec;28(6B):3997-4002.
The present study evaluated the clinical efficacy of chemotherapy in combination with cytokine-induced killer (CIK) biotherapy compared to the chemotherapy alone. Fifty-nine advanced non-small cell lung cancer (NSCLC) patients were randomly divided into two groups, group A (chemotherapy alone, including docetaxel 75 mg/m2, day 1; cisplatin, 25 mg/m2, days 1-4, tri-weekly) and group B (chemotherapy plus CIK cell transfusion). Autologous CIK cells were induced from the patients'peripheral mononuclear cells in vitro and separated by cytometry and then transfused back the patients. The host cellular immune function, clinical curative effects and quality of life (QOL) were examined and were compared between the two groups. The host immune function was enhanced and QOL was improved in the patients treated by chemotherapy plus CIK biotherapy compared to the patients treated by chemotherapy alone. The overall response rate (ORR) was 43.3% and 44.8% in groups A and B, respectively. The disease control rate (DCR) was higher in group B than in group A (89.7% vs. 65.5%, p = 0.030). The time to progression was 4.67 months (95% CI 3.98-6.02 months) in group A and 6.65 months (95% CI 4.70-7.30 months) in group B and the median survival time was 11.0 months (95% CI 7.88-14.1 months) in group A and 15.0 months (95% CI 11.04-18.96 months) in group B. Compared to patients in group A, the patients in group B had significantly longer progression-free survival (p = 0.042) and overall survival (p = 0.029). No severe side-effects occurred in the CIK cell transfusion patients. It was concluded that chemotherapy plus CIK cells has potential benefits compared to chemotherapy alone in patients suffering from advanced NSCLC and autologous CIK cell transfusion has no obvious side-effects.
本研究评估了化疗联合细胞因子诱导的杀伤细胞(CIK)生物疗法与单纯化疗相比的临床疗效。59例晚期非小细胞肺癌(NSCLC)患者被随机分为两组,A组(单纯化疗,包括多西他赛75mg/m²,第1天;顺铂25mg/m²,第1 - 4天,每三周一次)和B组(化疗加CIK细胞输注)。自体外周血单个核细胞诱导出患者的自体CIK细胞,通过细胞计数法分离后再回输至患者体内。检测两组患者的宿主细胞免疫功能、临床疗效及生活质量(QOL)并进行比较。与单纯化疗的患者相比,化疗联合CIK生物疗法治疗的患者宿主免疫功能增强,生活质量改善。A组和B组的总缓解率(ORR)分别为43.3%和44.8%。B组的疾病控制率(DCR)高于A组(89.7%对65.5%,p = 0.030)。A组的疾病进展时间为4.67个月(95%CI 3.98 - 6.02个月),B组为6.65个月(95%CI 4.70 - 7.30个月);A组的中位生存时间为11.0个月(95%CI 7.88 - 14.1个月),B组为15.0个月(95%CI 11.04 - 18.96个月)。与A组患者相比,B组患者的无进展生存期(p = 0.042)和总生存期(p = 0.029)显著更长。CIK细胞输注患者未发生严重副作用。结论是,对于晚期NSCLC患者,化疗加CIK细胞与单纯化疗相比具有潜在益处,且自体CIK细胞输注无明显副作用。