卡瑞利珠单抗联合化疗新辅助治疗局部晚期食管鳞癌的初步研究
Neoadjuvant camrelizumab plus chemotherapy in treating locally advanced esophageal squamous cell carcinoma patients: a pilot study.
机构信息
Department of Cardiothoracic Surgery, Daqing Oilfield General Hospital, Daqing, 163000, Heilongjiang, China.
Department of Oncology, Daqing Oilfield General Hospital, No. 9 Zhongkang Street, Saertu District, Daqing, 163000, Heilongjiang, China.
出版信息
World J Surg Oncol. 2021 Nov 22;19(1):333. doi: 10.1186/s12957-021-02446-5.
BACKGROUND
Camrelizumab (a PD-1 inhibitor) has been used as a potential therapy in unresectable advanced esophageal squamous cell carcinoma (ESCC) along with adjuvant treatment in locally advanced ESCC, exhibiting an acceptable efficacy and safety profile. This pilot study was designed to further investigate the clinical value and tolerance of neoadjuvant camrelizumab plus chemotherapy in locally advanced ESCC.
METHODS
A total of 16 patients with locally advanced ESCC were recruited. Patients received 2 cycles of neoadjuvant therapy including 2 doses of camrelizumab concurrent with 2 cycles of paclitaxel plus carboplatin followed by surgery 4 weeks afterward. Then, the treatment response after neoadjuvant therapy, R0 resection rate, tumor regression grade (TRG), and pathological complete remission (pCR) rate were measured. Besides, adverse events were documented. At last, progression-free survival (PFS) and overall survival (OS) were assessed.
RESULTS
Generally, objective remission rate (ORR) was 81.3% whereas disease control rate (DCR) was 100% after neoadjuvant therapy. Concerning TRG grade, 31.3, 37.5, 18.8, and 12.5% patients reached TRG0, TRG1, TRG2, and TRG3, respectively. Then, pCR rate and R0 resection rate were 31.3 and 93.8%, respectively. Besides, mean PFS and OS were 18.3 months (95%CI: (16.2-20.5) months) and 19.2 months (95%CI: (17.7-20.7) months), respectively, with a 1-year PFS of 83% and OS of 90.9%. Adverse events included white blood cell decrease (37.5%), neutrophil decrease (31.3%), reactive cutaneous capillary endothelial proliferation (37.5%), and nausea or vomiting (25.0%), which were relatively mild and manageable.
CONCLUSION
Neoadjuvant camrelizumab plus chemotherapy exhibits good efficacy and acceptable tolerance in patients with locally advanced ESCC.
背景
卡瑞利珠单抗（一种 PD-1 抑制剂）已被用于不可切除的晚期食管鳞状细胞癌（ESCC）的治疗，并在局部晚期 ESCC 中与辅助治疗联合使用，显示出可接受的疗效和安全性。本研究旨在进一步探讨新辅助卡瑞利珠单抗联合化疗在局部晚期 ESCC 中的临床价值和耐受性。
方法
共招募了 16 例局部晚期 ESCC 患者。患者接受 2 个周期的新辅助治疗，包括 2 剂卡瑞利珠单抗联合 2 个周期紫杉醇加卡铂，然后在 4 周后进行手术。然后，测量新辅助治疗后的治疗反应、R0 切除率、肿瘤消退分级（TRG）和病理完全缓解（pCR）率。此外，记录不良反应。最后，评估无进展生存期（PFS）和总生存期（OS）。
结果
总的来说，新辅助治疗后的客观缓解率（ORR）为 81.3%，疾病控制率（DCR）为 100%。关于 TRG 分级，31.3%、37.5%、18.8%和 12.5%的患者分别达到 TRG0、TRG1、TRG2 和 TRG3。然后，pCR 率和 R0 切除率分别为 31.3%和 93.8%。此外，平均 PFS 和 OS 分别为 18.3 个月（95%CI：（16.2-20.5）个月）和 19.2 个月（95%CI：（17.7-20.7）个月），1 年 PFS 率为 83%，OS 率为 90.9%。不良反应包括白细胞减少（37.5%）、中性粒细胞减少（31.3%）、反应性皮肤毛细血管内皮增生（37.5%）和恶心或呕吐（25.0%），相对较轻且易于管理。
结论
新辅助卡瑞利珠单抗联合化疗在局部晚期 ESCC 患者中具有良好的疗效和可接受的耐受性。
Zotero 插件