【摘要】 目的·评价DCVAC/LuCa联合培美曲塞/卡铂治疗Ⅳ期非小细胞肺癌患者的安全性。方法·将20例首次诊断为非鳞性、表皮生长因子受体(epidermal growth factor receptor,EGFR)野生型、间变性淋巴瘤激酶(anaplastic lymphoma kinase,ALK)阴性或未知的Ⅳ期非小细胞肺癌患者随机分为试验组(n=10)和对照组(n=10)。试验组患者接受培美曲塞/卡铂化学治疗(4～6个周期),在第3周期联合DCVAC/Lu Ca治疗,之后培美曲塞单药联合DCVAC/LuCa维持;对照组采用培美曲塞/卡铂化学治疗(4～6个周期),之后培美曲塞单药维持。评估患者疗效并统计治疗过程中患者发生的不良事件。结果·DCVAC/Lu Ca回输剂量与无进展生存期呈正相关(r=0.773,P=0.009)。2组患者治疗后的不良反应主要表现为白细胞减少、血红蛋白降低等化学治疗相关不良事件。所有的不良事件按照常见不良反应事件评价标准(common terminology criteria for adverse events,CTCAE)4.03版分级均为1级或2级,没有4级毒性或治疗相关死亡。试验组患者中,有1例患者在树突状细胞(dendritic cell,DC)回输后出现Ⅰ级非感染性发热和Ⅱ级全身疼痛,未经治疗恢复正常。结论·Ⅳ期非小细胞肺癌患者应用DCVAC/LuCa安全性较高,耐受性良好。更多还原

【Abstract】 Objective·To evaluate the safety of DCVAC/LuC a combined with pemetrexed/carboplatin in patients with stage Ⅳ non-small cell lung cancer(NSCLC). Methods·A total of 20 newly diagnosed stage Ⅳ, non-squamous, wild-type epidermal growth factor receptor(EGFR), anaplastic lymphoma kinase(ALK) negative or unknown NSCLC patients were randomized into test group(n=10) and control group(n=10). Test group received pemetrexed/carboplatin chemotherapy(4-6 cycles), combined with DCVAC/LuCa treatment in the third cycle, followed by pemetrexed monotherapy in combination with DCVAC/LuCa; control group received pemetrexed/carboplatin chemotherapy(4-6 cycles), followed by pemetrexed alone. The efficiency of the patients in two groups was evaluated and adverse effects(AEs) were collected and analyzed. Results·There was a significant positive correlation between DCVAC/LuCa transfusion dose and progression-free survival(PFS)(r=0.773, P=0.009). The common AEs in both groups were chemotherapy related leukopenia, hemoglobin decrease etc. All AEs were grade 1 or 2 according to common terminology criteria for adverse events(CTCAE) V4.03, and there were no grade 4 toxicities or treatment-related deaths. One patient in test group got non-infectious fever and body ache, and returned to normal without treatment. Conclusion·In patients with stage Ⅳ NSCLC, DCVAC/LuCa therapy is well tolerated with the favorable safety.更多还原