A Single-Arm Phase II Study to Evaluate Efficacy and Safety of First-Line Treatment With DCVAC/LuCa, Standard of Care Chemotherapy and Shenqi Fuzheng Injection in Advanced (Stage IIIB/IV) Non-Small Cell Lung Cancer Patients.
A Single-Arm Phase II Study to Evaluate Efficacy and Safety of First-Line Treatment With DCVAC/LuCa, Standard of Care Chemotherapy and Shenqi Fuzheng Injection in Advanced (Stage IIIB/IV) Non-Small Cell Lung Cancer Patients.
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评估 DCVAC/LuCa、标准护理化疗和参芪扶正注射液一线治疗晚期（IIIB/IV 期）非小细胞肺癌患者的有效性和安全性的单臂 II 期研究
DOI：
10.1177/15347354221083968
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发表时间：
2022-01
影响因子：
2.9
通讯作者：
Jia L
中科院分区：
文献类型：
--
作者：
Liu Q;Lou Y;Li L;Yang G;Cui H;Cheng Z;Li Y;Liu M;Deng C;Wan D;Yan Y;Jia L
目的：评价肺癌树突状细胞疫苗（DCVAC/LuCa）、标准化疗和参芪扶正注射液一线治疗晚期（IIIB/IV期）非小细胞肺癌患者的疗效和安全性。患者和方法：招募了经组织学或细胞学证实的复发性转移性或晚期NSCLC（IIIB/IV期）患者，这些患者携带野生型表皮生长因子受体（EGFR）或EGFR突变，但不会增加肿瘤对EGFR相互作用药物的敏感性。对于治疗期，标准治疗（SoC）的第一个周期在白细胞去除术后2 - 14天开始。SoC持续4至6个周期。DCVAC/LuCa从SoC的第二个周期开始给药。DCVAC/LuCa以3周周期方案（5次给药）给药，然后以6周周期方案给药。在每次DCVAC/LuCa给药前3天给予参芪扶正注射液，共14次每日给药。患者将每3个月通过计算机断层扫描（CT）进行一次疾病评估。主要和次要终点是客观缓解率（ORR）和无进展生存期（PFS）方面的疗效。通过以下指标衡量安全性特征：所有不良事件（AE）的发生率、类型和严重程度、实验室检查异常（血常规检查、尿液检查和化学检查）、身体状况和生命体征。采用《中医体质分类与判定》问卷调查和舌诊相结合的方法评价气虚。结果：23例患者来自3家医院接受联合治疗。ORR为34.8%（95% CI：16.4%-57.3%）。中位缓解持续时间为5.51 m（95% CI：2.70-8.32）。中位PFS为10.72 m（95% CI：4.52-16.93），1年生存率为77.8%。mOS为21.97 m（95% CI：13.68-30.25）。有1起与心脏病史相关的重度AE，没有与DCVAC/LuCa治疗相关的不良事件。气虚证由治疗前的41.19 ± 14.58改善为治疗后的10.52 ± 16.58，差异有统计学意义（P <0.0001）。结论：DCVAC/LuCa联合标准化疗和参芪扶正注射液在中国复发转移性或晚期（IIIB/IV期）NSCLC患者中显示出良好的获益，并显著改善气虚体质。DCVAC/LuCa治疗未发生相关不良事件。
Objectives: To evaluate the efficacy and safety of first-line treatment with a dendritic cell vaccination for lung cancer (DCVAC/LuCa), standard of care chemotherapy and Shenqi Fuzheng injection in patients with advanced (stage IIIB/IV) non-small cell lung cancer. Patients and Methods: Patients with histologically or cytologically confirmed recurrent metastatic or advanced NSCLC (stage IIIB/IV) with wild-type epidermal growth factor receptor (EGFR) or EGFR mutation which does not confer increased tumor susceptibility to EGFR-interacting drugs were recruited. For the treatment period, the first cycle of standard of care therapy (SoC) started 2 to 14 days after the leukapheresis procedure. SoC continued 4 to 6 cycles. DCVAC/LuCa was administered from the second cycle of SoC. DCVAC/LuCa was administered in a 3-week cycle schedule (5 doses) and then in a 6-week cycle schedule. Shenqi Fuzheng injection was administered 3 days before each DCVAC/LuCa administration for a total of 14 daily doses. Patients would undergo disease evaluation by computed tomography (CT) scan every 3 months. The primary and secondary endpoint was efficacy with regard to objective response rate (ORR) and progression free survival (PFS). The safety profile was measured by: incidence, type, and severity of all adverse events (AEs), laboratory abnormalities (blood routine test, urine test, and chemical test), physical status, and vital signs. Qi insufficiency was evaluated by tongue diagnosis and questionnaire survey with “Classification and Determination of constitution in TCM.” Results: Twenty-three patients from 3 hospitals who received combination therapy were included. ORR was 34.8% (95% CI:16.4%-57.3%). Median duration of response was 5.51 m (95% CI:2.70-8.32). Median PFS was 10.72 m (95% CI:4.52-16.93), 1-year survival was 77.8%. mOS was 21.97 m (95% CI:13.68-30.25). There was 1 severe AE related to a history of heart disease and there were no adverse events related to DCVAC/LuCa treatment. Qi insufficiency was improved significantly (P < .0001) from 41.19 ± 14.58 before treatment to 10.52 ± 16.58 after treatment. Conclusion: DCVAC/LuCa, combined with standard of care chemotherapy and Shenqi Fuzheng injection exhibited good benefit in Chinese patients with recurrent metastatic or advanced (stage IIIB/IV) NSCLC, and also significantly improved Qi insufficiency constitution. There were no related adverse events with DCVAC/LuCa treatment.
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影响因子：
--
作者：
Podrazil M;Horvath R;Becht E;Rozkova D;Bilkova P;Sochorova K;Hromadkova H;Kayserova J;Vavrova K;Lastovicka J;Vrabcova P;Kubackova K;Gasova Z;Jarolim L;Babjuk M;Spisek R;Bartunkova J;Fucikova J
通讯作者：
Fucikova J
影响因子：
8.4
作者：
Eisenhauer, E. A.;Therasse, P.;Verweij, J.
通讯作者：
Verweij, J.
DOI：
10.1038/nrc3258
发表时间：
2012-03-22
期刊：
Nature reviews. Cancer
影响因子：
--
作者：
通讯作者：
--
影响因子：
45.3
作者：
Scagliotti, Giorgio Vittorio;Parikh, Purvish;Gandara, David
通讯作者：
Gandara, David
影响因子：
5.4
作者：
Du, Juan;Cheng, Brian Chi Yan;Yu, Zhi-Ling
通讯作者：
Yu, Zhi-Ling