Department of Respiratory Medicine, The Affiliated Nanjing Brain Hospital of Nanjing Medical University, 215 Guangzhou Road, Nanjing, 210029, Jiangsu Province, China.
Clinical Center of Nanjing Respiratory Diseases and Imaging, Nanjing, 210029, Jiangsu, China.
BMC Pulm Med. 2022 Dec 29;22(1):490. doi: 10.1186/s12890-022-02292-5.
Stage III non-small cell lung cancer (NSCLC) is a heterogeneous disease with different subtypes, multidisciplinary teams-led management, and a poor prognosis. Currently, the clinical benefits of stage III NSCLC in the neoadjuvant setting are still unclear. We performed a meta-analysis of published data on neoadjuvant chemoimmunotherapy in stage III NSCLC to systematically evaluate its efficacy and safety.
We searched the databases to identify eligible studies of neoadjuvant chemoimmunotherapy for stage III NSCLC. The primary outcomes mainly included pathological and radiological response outcomes, the feasibility of surgery, and the safety of the regimen. The pathological and radiological response included the rate of major pathologic response (MPR), complete pathologic response (pCR), radiological response outcomes, and R0 resection; The feasibility included the rate of surgical resection, conversion to thoracotomy, surgical complications, pathological downstaging of clinical disease stage. The safety included the incidence of treatment-related adverse events (TRAEs) and severe adverse events (SAEs). R 4.1.3 software was conducted for data analysis, and p < 0.05 was considered statistically significant.
Nine trials containing a total of 382 populations were eligible for the meta-analysis, with the pooled surgical resection rate of 90%. Owing to the large heterogeneity of the single-rate meta-analysis, the random effect model was adopted. The estimated pooled prevalence of MPR was 56% (95%CI 0.39-0.72) and of pCR was 39% (95%CI 0.28-0.51). The pooled rate of TRAEs was 65% (95%CI 0.17-0.99) and SAEs was 24% (95%CI 0.05-0.49).
Compared to neoadjuvant chemotherapy or immunotherapy, neoadjuvant chemoimmunotherapy achieved more pathological and radiological relief, and has a high surgical resection rate and low risk of conversion to thoracotomy and surgical complications, with poor tolerance of toxicity but rarely developing life-threatening adverse events. In conclusion, neoadjuvant chemoimmunotherapy is suggested to be beneficial for stage III NSCLC.
III 期非小细胞肺癌（NSCLC）是一种异质性疾病，具有不同的亚型、多学科团队管理和预后不良。目前，III 期 NSCLC 新辅助治疗的临床获益仍不明确。我们对 III 期 NSCLC 新辅助化疗免疫治疗的已发表数据进行了荟萃分析，以系统评估其疗效和安全性。
我们检索了数据库，以确定 III 期 NSCLC 新辅助化疗免疫治疗的合格研究。主要结局主要包括病理和影像学反应结局、手术可行性和方案安全性。病理和影像学反应包括主要病理缓解（MPR）率、完全病理缓解（pCR）率、影像学反应结局和 R0 切除率；可行性包括手术切除率、转为开胸手术率、手术并发症发生率、临床疾病分期的病理降期率。安全性包括治疗相关不良事件（TRAEs）和严重不良事件（SAEs）的发生率。使用 R 4.1.3 软件进行数据分析，p<0.05 认为具有统计学意义。
共有 9 项试验包含 382 例人群符合荟萃分析条件，手术切除率为 90%。由于单项比率荟萃分析的异质性较大，采用了随机效应模型。估计的 MPR 总体患病率为 56%（95%CI 0.39-0.72），pCR 为 39%（95%CI 0.28-0.51）。TRAEs 的总体发生率为 65%（95%CI 0.17-0.99），SAEs 为 24%（95%CI 0.05-0.49）。
与新辅助化疗或免疫治疗相比，新辅助化疗免疫治疗在病理和影像学方面取得了更大的缓解，具有较高的手术切除率和低转化为开胸手术及手术并发症的风险，毒性耐受性差，但很少发生危及生命的不良事件。总之，新辅助化疗免疫治疗对 III 期 NSCLC 有益。
