DCVAC/LuCa联合化疗治疗晚期非小细胞肺癌安全性的探讨
Safety of DCVAC/LuCa combined with chemotherapy for treating advanced non-small cell lung cancer

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（ n10）和对照组（ n10）。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/LuCa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/LuCa回输剂量与无进展生存期呈正相关（r0.773，P0.009）。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。
：Objective · To evaluate the safety of DCVAC/LuCa 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 (n10) and control group (n10). Test group received pemetrexed/ carboplatin chemotherapy (4-6 cycles), combined with DCVAC/LuCa treatment in the third cycle, followedpemetrexed monotherapy in combination with DCVAC/LuCa; control group received pemetrexed/carboplatin chemotherapy (4-6 cycles), followedpemetrexed alone. The efficiency of the patientsintwogroups wasevaluated andadverseeffects (AEs)werecollected andanalyzed. Results · Therewas a significantpositivecorrelation between DCVAC/LuCa transfusion dose and progression-free survival (PFS) (r0.773, P0.009). The common AEs in both groups were chemotherapy related leukopenia, hemoglobin decrease etc.AllAEs 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