新辅助放化疗联合免疫治疗用于局部晚期食管鳞状细胞癌的安全性和可行性：一项前瞻性单组II期临床研究
Safety and feasibility of neoadjuvant chemoradiotherapy combined with immunotherapy for locally advanced esophageal squamous cell carcinoma: a prospective single-group phase II clinical study.
作者信息
Cheng Lei, Wang Xinyi, Shen Haixia, Wang Jin, Yang Yang, Wu Wei, Mehmood Rashid, Shen Dijian, Jiang Youhua, Ji Yongling
机构信息
Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou, China.
Key Laboratory of Diagnosis and Treatment Technology for Thoracic Cancer of Zhejiang Province, Hangzhou, China.
出版信息
J Thorac Dis. 2024 Oct 31;16(10):7029-7041. doi: 10.21037/jtd-24-1279. Epub 2024 Oct 17.
BACKGROUND
Neoadjuvant chemoradiotherapy (nCRT) combined with surgery is still the standard treatment mode for esophageal cancer (EC), but the rate of distant metastasis and local recurrence of this triple mode is still high. Distant metastasis is the main recurrence pattern. Therefore, there is an urgent need to explore a new treatment model to improve pathologic complete response (pCR) and patient survival. In recognition of the rise of immunotherapy, this study aimed to investigate the efficacy and safety of nCRT combined with immunotherapy (nRCIT) in patients with esophageal squamous cell carcinoma (ESCC).
METHODS
A total of 22 patients with locally advanced ESCC were enrolled at our institution between 2019 and 2021. The patients underwent nRCIT therapy. The primary endpoint was pCR; secondary endpoints included major pathologic response (MPR), 1- and 2-year overall survival (OS) and disease-free survival (DFS), and adverse events (AEs). Meanwhile, we enrolled 53 patients with ESCC who underwent nCRT at our institution as the control group between 2012 and 2019. A 1:1 propensity score matching (PSM) with a caliper 0.374 was performed to balance potential bias.
RESULTS
In present work, 17 patients successfully completed nRCIT and esophagectomy, among whom 16 patients achieved R0 resection. After PSM, age, sex, tumor location, length, alcohol history, body mass index (BMI), clinical T stage, lymph node staging, tumor-node-metastasis (TNM) staging, and cycles of chemotherapy were comparable between groups. After the operation, 7 patients (41.2%) achieved pCR in both primary tumors and lymph nodes. Anastomotic leakage occurred in 3 patients (17.6%) and 1 patient succumbed to pneumonia during the perioperative period. Leukopenia was observed in 20 patients (90.9%) during neoadjuvant therapy, with grade 3 or higher AEs. The 1- and 2-year OS rates are 88.2% and 65.0%, respectively, in the nRCIT group, whereas 34.1% of patients achieved pCR, with 1- and 2-year OS rates of 82.3% and 68.6%, respectively, in the nCRT group. A significant MPR was observed in 10 out of 17 patients (58.8%) in the nRCIT group.
CONCLUSIONS
nRCIT may appear to be safe and feasible for locally advanced ESCC.
背景
新辅助放化疗（nCRT）联合手术仍是食管癌（EC）的标准治疗模式，但这种三联模式的远处转移率和局部复发率仍然很高。远处转移是主要的复发模式。因此，迫切需要探索一种新的治疗模式来提高病理完全缓解（pCR）率和患者生存率。鉴于免疫治疗的兴起，本研究旨在探讨新辅助放化疗联合免疫治疗（nRCIT）在食管鳞状细胞癌（ESCC）患者中的疗效和安全性。
方法
2019年至2021年期间，共有22例局部晚期ESCC患者在本机构入组。这些患者接受了nRCIT治疗。主要终点是pCR；次要终点包括主要病理反应（MPR）、1年和2年总生存期（OS）及无病生存期（DFS），以及不良事件（AE）。同时，我们纳入了2012年至2019年期间在本机构接受nCRT的53例ESCC患者作为对照组。采用卡尺为0.374的1:1倾向评分匹配（PSM）来平衡潜在偏倚。
结果
在本研究中，17例患者成功完成nRCIT及食管切除术，其中16例患者实现了R0切除。PSM后，两组间年龄、性别、肿瘤位置、长度、饮酒史、体重指数（BMI）、临床T分期、淋巴结分期、肿瘤-淋巴结-转移（TNM）分期及化疗周期具有可比性。术后，7例患者（41.2%）在原发肿瘤和淋巴结均达到pCR。3例患者（17.6%）发生吻合口漏，1例患者在围手术期死于肺炎。新辅助治疗期间，20例患者（90.9%）出现白细胞减少，为3级或更高等级的AE。nRCIT组1年和2年OS率分别为88.2%和65.0%，而nCRT组34.1%的患者达到pCR，1年和2年OS率分别为82.3%和68.6%。nRCIT组17例患者中有10例（58.8%）观察到显著的MPR。
结论
nRCIT对于局部晚期ESCC似乎是安全可行的。
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