上海交通大学学报（医学版）

上海交通大学学报（医学版） ›› 2018, Vol. 38 ›› Issue (8): 923-.doi: 10.3969/j.issn.1674-8115.2018.08.011

• 论著·临床研究 • 上一篇    下一篇

DCVAC/LuCa联合化疗治疗晚期非小细胞肺癌安全性的探讨

曹淑慧，周严，李静文，钟华   

  1. 上海交通大学附属胸科医院呼吸内科，上海 200030
  • 出版日期:2018-08-28 发布日期:2018-09-11
  • 通讯作者: 钟华，电子信箱：eddiedong8@hotmail.com。
  • 作者简介:曹淑慧（1994—），女，硕士生；电子信箱： shcao024@163.com。
  • 基金资助:
    上海市教育委员会高峰高原学科建设计划（20161434）；国家自然科学基金（ 81472642）

Safety of DCVAC/LuCa combined with chemotherapy for treating advanced non-small cell lung cancer

CAO Shu-hui, ZHOU yan, LI Jing-wen, ZHONG Hua   

  1. Department of Respiratory, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China
  • Online:2018-08-28 Published:2018-09-11
  • Supported by:
    Shanghai Municipal Education Commission—Gaofeng Clinical Medicine Support, 20161434; National Natural Science Foundation of China, 81472642

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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（ 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。

关键词: 树突状细胞, 非小细胞肺癌, 安全性

Abstract:

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.

Key words: dendritic cell, non-small cell lungcancer (NSCLC), safety

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