Lv Huilai, Tian Yang, Li Jiachen, Huang Chao, Sun Bokang, Gai Chunyue, Li Zhenhua, Tian Ziqiang
Department of Thoracic Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
Department of Thoracic and Cardiac Surgery, Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou, China.
Front Oncol. 2022 Apr 29;12:864533. doi: 10.3389/fonc.2022.864533. eCollection 2022.
Neoadjuvant chemotherapy (nCT) and chemoradiotherapy (nCRT) are the standard treatments in patients with resectable locally advanced esophageal squamous cell carcinoma (ESCC). Adding PD-1 inhibitor to the chemotherapy has shown significant clinical benefits in first-line treatment of advanced ESCC. This study evaluated the efficacy and safety of neoadjuvant sintilimab plus chemotherapy in patients with resectable locally advanced ESCC.
The clinical data of 96 patients with resectable locally advanced ESCC, treated with sintilimab plus chemotherapy followed by esophagectomy, were reviewed. The pathologic complete response (pCR) rate, major pathological response (MPR) rate, R0 resection rate, tumor downstaging, survival, and safety were retrospectively analyzed.
Patients were between the ages of 43 and 78 years (interquartile range [IQR], 60-69 years). Forty (41.7%) were diagnosed with stage II ESCC, 52 (54.2%) with stage III, and 4 (4.2%) with stage IVA. Sixty-seven (69.8%) were male, and 84 (87.5%) patients had an ECOG PS of ≤1. Forty-eight (50.0%) patients received 3-4 cycles of the neoadjuvant treatment. Twenty-nine (30.2%) patients obtained pCR, and MPR was achieved in 60 (62.5%) patients. The R0 resection rate was 99%. Eighty (83.3%) patients achieved clinical downstaging, and 71 (74.0%) achieved pathological downstaging. The median follow-up was 8.9 months, and 1-year DFS rate was 95.2% (95% CI, 88.8%-100%). Grade 3-4 TRAEs occurred in 12 (12.5%) patients, and the incidence of grade 3-4 surgical complications was 2.1%. No deaths were reported.
These real-world data revealed that neoadjuvant sintilimab plus chemotherapy could provide encouraging pCR with good tolerability for resectable locally advanced ESCC, and this regimen warrants further exploration in prospective clinical studies.
新辅助化疗（nCT）和放化疗（nCRT）是可切除的局部晚期食管鳞状细胞癌（ESCC）患者的标准治疗方法。在晚期ESCC的一线治疗中，在化疗基础上加用PD-1抑制剂已显示出显著的临床益处。本研究评估了新辅助信迪利单抗联合化疗在可切除的局部晚期ESCC患者中的疗效和安全性。
回顾了96例接受信迪利单抗联合化疗后行食管切除术的可切除局部晚期ESCC患者的临床资料。回顾性分析病理完全缓解（pCR）率、主要病理缓解（MPR）率、R0切除率、肿瘤降期、生存率和安全性。
患者年龄在43至78岁之间（四分位间距[IQR]，60 - 69岁）。40例（41.7%）诊断为II期ESCC，52例（54.2%）为III期，4例（4.2%）为IVA期。67例（69.8%）为男性，84例（87.5%）患者的东部肿瘤协作组（ECOG）体能状态（PS）≤1。48例（50.0%）患者接受了3 - 4周期的新辅助治疗。29例（30.2%）患者获得pCR，60例（62.5%）患者达到MPR。R0切除率为99%。80例（83.3%）患者实现了临床降期，71例（74.0%）实现了病理降期。中位随访时间为8.9个月，1年无病生存率（DFS）为95.2%（95%CI，88.8% - 100%）。12例（12.5%）患者发生3 - 4级治疗相关不良反应（TRAEs），3 - 4级手术并发症发生率为2.1%。无死亡报告。
这些真实世界数据表明，新辅助信迪利单抗联合化疗可为可切除的局部晚期ESCC提供令人鼓舞的pCR且耐受性良好，该方案值得在前瞻性临床研究中进一步探索。
