CELL INTELLIGENCE · 肿瘤细胞治疗研究

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基于树突状细胞的免疫治疗（DCVAC/LuCa）联合卡铂/培美曲塞用于无驱动基因突变的晚期非鳞状非小细胞肺癌患者的安全性和有效性

英文原题：Safety and efficacy of dendritic cell-based immunotherapy (DCVAC/LuCa) combined with carboplatin/pemetrexed for patients with advanced non-squamous non-small-cell lung cancer without oncogenic drivers.

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Safety and efficacy of dendritic cell-based immunotherapy (DCVAC/LuCa) combined with carboplatin/pemetrexed for patients with advanced non-squamous non-small-cell lung cancer without oncogenic drivers.

PubMed 2021/12/24（内容时间） ESMO Open Q1 · IF 10.6（JCR 2025）

分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。

技术：树突状细胞疫苗非小细胞肺癌地区：欧洲
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研究概要

在无致癌驱动基因的初治 IV 期非鳞状 NSCLC 患者中，卡铂/培美曲塞联合 DCVAC/LuCa 耐受性良好，并显示出有前景的疗效。因此，计划开展一项随机 III 期试验以证明我们的免疫治疗理念。

研究思路结论见上方概要

背景

我们的前瞻性、开放标签、单臂II期研究探讨了DCVAC/LuCa（肺癌树突状细胞疫苗）联合标准化疗卡铂/培美曲塞在晚期非鳞状（nsq）非小细胞肺癌（NSCLC）中的安全性和有效性。

方法

符合条件的患者为IV期非鳞状NSCLC，无致癌驱动基因突变，且未接受过既往全身性抗肿瘤治疗。治疗包括卡铂/培美曲塞最多6个周期，随后培美曲塞维持治疗21个周期，或直至疾病进展或不耐受。化疗两周期后未进展的患者自第3周期第15天开始接受DCVAC/LuCa皮下注射（s.c.），此后每3周一次（化疗周期的第15天），最多15剂。DCVAC/LuCa皮下注射的剂量因患者基线白细胞计数而异，但每位患者保持恒定。安全性通过不良事件（AEs）、治疗相关不良事件（TRAEs）、严重不良事件（SAEs）和特别关注的不良事件（AESIs）进行评估。疗效通过总生存期（OS）、无进展生存期（PFS）、至进展时间（TTP）和客观缓解率（ORR）进行衡量。

结果

共入组61例患者。在安全性人群（n=60）中，8例患者（13.33%）出现3级或以上TRAEs，6例患者（10.0%）出现与白细胞分离术或DC疫苗无关的SAEs。6例1级AEs被认为与白细胞分离术相关。未观察到AESIs或DCVAC/LuCa诱导的AEs。改良意向治疗人群（n=44）的2年生存率为52.57%。中位OS未达到。中位PFS为8.0个月，中位TTP为10.2个月，ORR为31.82%。

展开英文摘要原文
BACKGROUND

Our prospective, open-label, single-arm phase II study investigated the safety and efficacy of DCVAC/LuCa (dendritic cell vaccines for lung cancer) combined with standard carboplatin/pemetrexed in advanced non-squamous (nsq) non-small-cell lung cancer (NSCLC).

PATIENTS AND METHODS

Eligible patients had stage IV nsq NSCLC without oncogenic drivers and had not received prior systemic cancer therapy. Treatment consisted of carboplatin/pemetrexed for up to 6 cycles followed by 21 cycles of pemetrexed maintenance or until progression or intolerance. Non-progression patients after two cycles of chemotherapy started to receive DCVAC/LuCa subcutaneously (s.c.) on day 15 of cycle 3, and thereafter q3w (day 15 of chemotherapy cycles) for up to 15 doses. Dosing of DCVAC/LuCa s.c. varied among patients depending on the baseline number of leucocytes but remained constant for each single patient. Safety was assessed by adverse events (AEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs). Efficacy was measured by overall survival (OS), progression-free survival (PFS), time to progression (TTP), and objective response rate (ORR).

RESULTS

Sixty-one patients were enrolled. In the safety population (n = 60), eight patients (13.33%) had grade 3 or greater TRAEs, and six patients (10.0%) showed SAEs which were not related to leukapheresis or DC vaccination. Six grade 1 AEs were considered to be related to leukapheresis. No AESIs or DCVAC/LuCa-induced AEs were observed. The 2-year survival rate in the modified intention-to-treat population (n = 44) was 52.57%. Median OS was not reached. Median PFS was 8.0 months, median TTP was 10.2 months, and the ORR was 31.82%.

CONCLUSION

In treatment-naïve stage IV nsq NSCLC patients without oncogenic drivers, the combination of carboplatin/pemetrexed and DCVAC/LuCa was well tolerated and showed promising efficacy. Therefore, a study to prove our immunotherapeutic concept in a randomized phase III trial is planned.

论文信息

作者
Zhong R、Ling X、Cao S、Xu J、Zhang B、Zhang X、Wang H、Han B
第一作者单位
Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China.Germany
通讯作者单位
Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China. Electronic address: eddiedong8@hotmail.com.Germany
文献类型
II 期临床试验 · 非美国政府资助研究
期刊
ESMO open2022 Feb
原文标识
PubMed 34959168　·　DOI 10.1016/j.esmoop.2021.100334

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