Department of Radiation Oncology, Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing, China.
Department of Pathology, Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing, China.
Int Immunopharmacol. 2024 Sep 10;138:112558. doi: 10.1016/j.intimp.2024.112558. Epub 2024 Jun 27.
This study aims to analyze the efficacy and safety of neoadjuvant programmed cell death-1 (PD-1) blockade plus chemotherapy in real-world applications. Additionally, we report survival outcomes with a median follow-up of 40.1 months.
From January 2018 to October 2022, we retrospectively recruited patients with esophageal squamous cell carcinoma (ESCC) who underwent surgery after receiving PD-1 blockade (immunotherapy) plus chemotherapy at Jiangsu Cancer Hospital.
A total of 132 eligible ESCC patients were included, and R0 resection was achieved in 131 cases (99.2 %). A complete pathological response rate (ypT0N0) was observed in 32 patients (24.2 %), and the objective response rate was 59.1 %. The most common grade 3-4 treatment-related adverse events (TRAEs) were leukopenia (18.2 %) and neutropenia (15.9 %). Three cases (2.3 %) of grade 3 immune-related AEs were observed, including increased ALT (0.8 %), rash (0.8 %), and encephalitis (0.8 %). The 1-year disease-free survival (DFS) and overall survival (OS) rates were 68.2 % and 89.4 %, respectively, and the 2-year DFS and OS rates were 55.1 % and 78.6 %, respectively. The pathological responses of 103 cases (94.5 % of 109) of the index lymph node (ILN) were categorized as the worst regression subgroup. In these cases, using the pathological response of the ILN to indicate the status of other lymph nodes would not result to a missed therapeutic lymph node dissection.
Neoadjuvant immunotherapy plus chemotherapy is safe and effective for ESCC, with observable survival benefits. The pathological response of the ILN after neoadjuvant therapy may have important value in guiding therapeutic lymph node dissection.
本研究旨在分析程序性死亡受体-1（PD-1）抑制剂联合化疗的新辅助治疗在真实世界中的疗效和安全性，并报告中位随访时间为 40.1 个月的生存结果。
自 2018 年 1 月至 2022 年 10 月，我们回顾性招募了在江苏省肿瘤医院接受 PD-1 抑制剂（免疫治疗）联合化疗后接受手术治疗的食管鳞状细胞癌（ESCC）患者。
共纳入 132 例符合条件的 ESCC 患者，131 例（99.2%）达到 R0 切除。32 例（24.2%）患者出现完全病理缓解（ypT0N0），客观缓解率为 59.1%。最常见的 3-4 级治疗相关不良事件（TRAEs）是白细胞减少（18.2%）和中性粒细胞减少（15.9%）。3 例（2.3%）患者出现 3 级免疫相关不良事件，包括 ALT 升高（0.8%）、皮疹（0.8%）和脑炎（0.8%）。1 年无病生存率（DFS）和总生存率（OS）分别为 68.2%和 89.4%，2 年 DFS 和 OS 率分别为 55.1%和 78.6%。103 例（109 例的 94.5%）索引淋巴结（ILN）的病理反应分为最差消退亚组。在这些病例中，使用 ILN 的病理反应来指示其他淋巴结的状态不会导致治疗性淋巴结清扫的遗漏。
新辅助免疫治疗联合化疗对 ESCC 安全有效，可观察到生存获益。新辅助治疗后 ILN 的病理反应可能对指导治疗性淋巴结清扫具有重要价值。
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