Department of Internal Medicine, Shandong Tumor Hospital, Jinan, China.
J Immunother. 2014 May;37(4):250-5. doi: 10.1097/CJI.0000000000000015.
The aim of this study was to evaluate the safety and effectiveness of erlotinib plus DC/CIK in maintenance therapy of advanced non-small cell lung cancer. After 4 cycles of the 2-drug regimen treatment with platinum, the 54 patients with non-small cell lung cancer in phase IIIb or IV reached stable or beyond stable stages. The patients were then randomly divided into 2 groups. One group was treated with erlotinib therapy (erlotinib group), and the other was treated with DC/CIK plus erlotinib (DC/CIK plus erlotinib group). The progression-free survival of the erlotinib group and the DC/CIK plus erlotinib group was 3.98 months (95% CI, 3.56-4.40) and 5.02 months (95% CI, 4.32-5.72) (P=0.002), respectively. The median overall survival of the erlotinib group and the DC/CIK plus erlotinib group was 9.9 months (95% CI, 9.1-10.6) and 10.5 months (95% CI, 9.6-11.4) (P=0.29), respectively. The levels of CD3, CD4, and CD8 were significantly different before and after the treatment in the DC/CIK plus erlotinib group, but not in the erlotinib group. There was no significant difference in toxicity between the 2 groups. In conclusion, there was no statistically significant difference in overall survival between DC/CIK plus erlotinib and erlotinib as maintenance therapy. DC/CIK plus erlotinib was well tolerated with a manageable safety profile.
本研究旨在评估厄洛替尼联合 DC/CIK 在晚期非小细胞肺癌维持治疗中的安全性和有效性。在接受 4 个周期的含铂 2 药方案治疗后，IIIb 期或 IV 期的 54 例非小细胞肺癌患者达到稳定或更稳定阶段。然后，患者被随机分为 2 组。一组接受厄洛替尼治疗（厄洛替尼组），另一组接受 DC/CIK 联合厄洛替尼治疗（DC/CIK 联合厄洛替尼组）。厄洛替尼组和 DC/CIK 联合厄洛替尼组的无进展生存期分别为 3.98 个月（95%CI，3.56-4.40）和 5.02 个月（95%CI，4.32-5.72）（P=0.002）。厄洛替尼组和 DC/CIK 联合厄洛替尼组的中位总生存期分别为 9.9 个月（95%CI，9.1-10.6）和 10.5 个月（95%CI，9.6-11.4）（P=0.29）。DC/CIK 联合厄洛替尼组治疗前后 CD3、CD4 和 CD8 水平差异有统计学意义，而厄洛替尼组无差异。两组毒性无显著差异。结论：在维持治疗中，DC/CIK 联合厄洛替尼与厄洛替尼的总生存期无统计学差异。DC/CIK 联合厄洛替尼耐受性良好，安全性可控。
