Lin Wenbao, Huang Yangyun, Zhu Lihuan, Li Wujin, Zhao Lilan, Pan Xiaojie, Lin Jinlan, Guo Tianxing
Department of Thoracic Surgery, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, China.
Department of Thoracic Oncology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, China.
J Gastrointest Oncol. 2022 Dec;13(6):2758-2768. doi: 10.21037/jgo-22-1196.
Pembrolizumab has been shown to have a powerful benefit for locally advanced or metastatic esophageal cancer. The aim of present study was to evaluate the efficacy and safety of pembrolizumab combined with neoadjuvant chemotherapy for locally advanced and potentially resectable esophageal squamous cell carcinoma (ESCC).
Patients diagnosed with clinical stage III-IV ESCC and have a chance of resectability at Fujian Provincial Hospital were included into this study. Patients received pembrolizumab in combination with paclitaxel and nedaplatin as induction therapy once every 3 weeks in the first stage. After 4 cycles of pembrolizumab therapy, the patients then chose to undergo radical surgery (group A), radical radiotherapy (group B), or neither (group C). In the third stage, maintenance treatment with pembrolizumab was administered to all patients.
A total of 39 patients (33 male and 6 female) with a median age of 64 years were included. After immune response evaluation in the first stage, 34 (87.2%) patients achieved immune partial response (iPR), and 5 (12.8%) patients achieved immune stable disease (iSD). The objective response rate (ORR) was 87.2% (34/39), and the disease control rate (DCR) was 100%. In the second stage, 22 patients received radical surgery, all of whom achieved R0 resection. The major pathological response (MPR) rate was 68.2% (15/22), and the pathological complete response (pCR) rate was 45.5% (10/22). Of the patients, 9 chose radiotherapy as the radical therapeutic method and 8 chose not to undergo any radical therapy. The median period of pembrolizumab therapy was 8 cycles (4-22 cycles). The median follow-up time was 14 months (3-34 months). The median overall survival and progression-free survival (PFS) times were not reached. The incidence of severe adverse events (AEs) (grade ≥3) was 15.4% (6/39).
Pembrolizumab combined with paclitaxel and platinum for locally advanced and potentially resectable ESCC has a high ORR, high surgical conversion, MPR, pCR, and R0 resection rates, and tolerable AEs. Also, pembrolizumab could provide good benefits in sequential treatment with radical radiotherapy or maintenance therapy.
帕博利珠单抗已被证明对局部晚期或转移性食管癌有显著疗效。本研究旨在评估帕博利珠单抗联合新辅助化疗治疗局部晚期且可能可切除的食管鳞状细胞癌（ESCC）的疗效和安全性。
纳入在福建省立医院被诊断为临床III-IV期ESCC且有切除机会的患者。患者在第一阶段接受帕博利珠单抗联合紫杉醇和顺铂作为诱导治疗，每3周一次。在接受4个周期的帕博利珠单抗治疗后，患者选择接受根治性手术（A组）、根治性放疗（B组）或两者都不接受（C组）。在第三阶段，所有患者接受帕博利珠单抗维持治疗。
共纳入39例患者（男性33例，女性6例），中位年龄64岁。在第一阶段进行免疫反应评估后，34例（87.2%）患者达到免疫部分缓解（iPR），5例（12.8%）患者达到免疫稳定疾病（iSD）。客观缓解率（ORR）为87.2%（34/39），疾病控制率（DCR）为100%。在第二阶段，22例患者接受了根治性手术，所有患者均实现R0切除。主要病理缓解（MPR）率为68.2%（15/22），病理完全缓解（pCR）率为45.5%（10/22）。其中，9例患者选择放疗作为根治性治疗方法，8例患者选择不接受任何根治性治疗。帕博利珠单抗治疗的中位周期数为8个周期（4-22个周期）。中位随访时间为14个月（3-34个月）。中位总生存期和无进展生存期（PFS）均未达到。严重不良事件（AE）（≥3级）的发生率为15.4%（6/39）。
帕博利珠单抗联合紫杉醇和铂类治疗局部晚期且可能可切除的ESCC具有较高的ORR、较高的手术转化率、MPR、pCR和R0切除率，且AE可耐受。此外，帕博利珠单抗在与根治性放疗或维持治疗的序贯治疗中可提供良好疗效。
