Feng Yuqian, Guo Kaibo, Jin Huimin, Jiang Jing, Wang Menglei, Lin Shengyou
Hangzhou School of Clinical Medicine, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.
Department of Oncology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Expert Rev Anticancer Ther. 2024 Mar-Apr;24(3-4):169-181. doi: 10.1080/14737140.2024.2325404. Epub 2024 Mar 4.
Neoadjuvant immunotherapy has emerged as a prominent research focus recently. For potentially operable patients, neoadjuvant therapy serves as a primary method to reduce tumor load and facilitate surgical interventions.
We retrieved articles from PubMed, Embase, Cochrane Library, American Society of Clinical Oncology, and European Society of Medical Oncology websites from inception to December 2023. Statistical analyses were performed using the R software. Primary outcomes assessed included major pathological response (MPR), pathological complete response (pCR), and treatment-related adverse events (trAEs).
29 studies encompassing 1163 patients were included. The MPR rate of neoadjuvant combination immunotherapy was 38% (95% confidence interval [CI]: 25%-52%), and the pCR rate was 33% (95%CI: 25%-42%). These values were significantly higher than those obtained with single agent immunotherapy ( < 0.001). The pooled incidence of overall trAEs was 83% (95%CI: 73%-92%), and grade (G) 3-4 trAEs was 22% (95%CI: 15%-29%), both significantly higher than those observed with single agent immunotherapy ( < 0.05).
This study demonstrated the efficacy of neoadjuvant combination immunotherapy. Given that the majority of the included trials were phase II with small sample sizes, further multicenter phase III randomized controlled trials should be conducted to validate the findings of the review.
新辅助免疫疗法最近已成为一个突出的研究重点。对于潜在可手术的患者,新辅助治疗是降低肿瘤负荷并促进手术干预的主要方法。
我们检索了从创刊至2023年12月期间来自PubMed、Embase、Cochrane图书馆、美国临床肿瘤学会和欧洲医学肿瘤学会网站的文章。使用R软件进行统计分析。评估的主要结局包括主要病理缓解(MPR)、病理完全缓解(pCR)和治疗相关不良事件(trAE)。
纳入了29项研究,共1163例患者。新辅助联合免疫疗法的MPR率为38%(95%置信区间[CI]:25%-52%),pCR率为33%(95%CI:25%-42%)。这些值显著高于单药免疫疗法(<0.001)。总体trAE的合并发生率为83%(95%CI:73%-92%),3-4级trAE为22%(95%CI:15%-29%),两者均显著高于单药免疫疗法(<0.05)。
本研究证明了新辅助联合免疫疗法的疗效。鉴于纳入的试验大多为II期且样本量较小,应开展进一步的多中心III期随机对照试验以验证本综述的结果。