Comparison of efficacy and safety between pembrolizumab combined with chemotherapy and simple chemotherapy in neoadjuvant therapy for esophageal squamous cell carcinoma
Comparison of efficacy and safety between pembrolizumab combined with chemotherapy and simple chemotherapy in neoadjuvant therapy for esophageal squamous cell carcinoma
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DOI：
10.21037/jgo-21-610
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发表时间：
2021-10-01
影响因子：
2.1
通讯作者：
Li, Xiaojian
中科院分区：
文献类型：
--
作者：
Huang, Bingjiang;Shi, Haiyan;Li, Xiaojian
背景：免疫治疗可以激活肿瘤抗原的识别，建立免疫记忆，越来越多的临床试验将免疫化疗或免疫放疗方案作为食管鳞状细胞癌（ESCC）的治疗策略。我们的目的是比较派姆单抗联合化疗组和单纯化疗在ESCC新辅助治疗中的疗效和安全性。方法：2018年1月至2020年12月，中山大学第五附属医院入选54例ESCC II-IVa期患者，其中派姆单抗联合化疗组（联合组）23例，单纯化疗组31例。所有患者在新辅助治疗两个周期后均接受根治性手术治疗。结果：联合组病理完全缓解（pCR）和客观缓解率（ORR）均显著高于单纯化疗组（30.4%比9.7%，P=0.048； 86.9%比95.7%，P=0.017），肿瘤消退评分>= 2（80.7%比50.0%，P=0.013）。两组食管切除术完成率和R0 /R1切除率比较，差异均无统计学意义。除此之外，联合组不良事件发生率与单纯化疗组相似。结论：Pembrolizumab联合化疗显示出有希望的活性和可控的安全性。为ESCC患者提供了一种潜在的新辅助治疗方法。
Background: Immunotherapy can activate the recognition of tumor antigen, build immune memory, and more and more clinical trials have taken the scheme of immunochemotherapy or immunoradiotherapy as a treatment strategy for esophageal squamous cell carcinoma (ESCC). Our objective was to compare the efficacy and safety between pembrolizumab combined with the chemotherapy group and simple chemotherapy in neoadjuvant therapy of ESCC. Methods: Fifty-four ESCC patients with stage II-IVa were enrolled at the Fifth Affiliated Hospital of Sun Yat-sen University between January 2018 and December 2020, including 23 in the pembrolizumab combined with chemotherapy group (combined group), and 31 in the simple chemotherapy group. All patients received radical surgical treatment after two cycles of neoadjuvant therapy. Results: The pathological complete response (pCR) and objective response rate (ORR) in the combined group were significantly higher than that of the simple chemotherapy group (30.4% vs. 9.7%, P=0.048; 86.9% vs. 95.7%, P=0.017) as well as the score of tumor regression >= 2 (80.7% vs. 50.0%, P=0.013). And the complete rate of esophagectomy and R0 /R1 resection rate in the two groups were not statistically significant. Otherwise, the incidence of adverse events in the combined group was similar compared with the simple chemotherapy group. Conclusions: Pembrolizumab combined with chemotherapy showed promising activity with a manageable safety profile. And it could offer a potential new neoadjuvant treatment approach for patients with ESCC.