国际肿瘤学杂志 ›› 2024, Vol. 51 ›› Issue (6): 326-331.doi: 10.3760/cma.j.cn371439-20230818-00056

• 论著 • 上一篇    下一篇

Ⅲ~ⅣA期食管鳞状细胞癌放化疗后行巩固化疗的疗效:一项真实世界临床研究

钱晓涛(), 石子宜, 胡格, 吴晓维   

  1. 中国科学院合肥肿瘤医院肿瘤科,合肥 230000
  • 收稿日期:2023-08-18 修回日期:2024-03-06 出版日期:2024-06-08 发布日期:2024-06-28
  • 通讯作者: 钱晓涛,Email: moranqxt@163.com

Efficacy of consolidation chemotherapy after radical radiotherapy and chemotherapy for stage Ⅲ-ⅣA esophageal squamous cell carcinoma: a real-world clinical study

Qian Xiaotao(), Shi Ziyi, Hu Ge, Wu Xiaowei   

  1. Department of Oncology, Hefei Cancer Hospital, Chinese Academy of Sciences, Hefei 230000, China
  • Received:2023-08-18 Revised:2024-03-06 Online:2024-06-08 Published:2024-06-28
  • Contact: Qian Xiaotao, Email: moranqxt@163.com

摘要:

目的 探讨Ⅲ~ⅣA期食管鳞状细胞癌(ESCC)患者放化疗后行巩固化疗在真实世界的疗效。方法 回顾性分析2018年1月1日至2022年12月31日中国科学院合肥肿瘤医院收治的139例Ⅲ~ⅣA期行放化疗ESCC患者的临床资料。根据患者放化疗后是否行巩固化疗,将患者分为对照组(n=85)和巩固化疗组(n=54)。比较两组客观缓解率(ORR)、疾病控制率(DCR)、无进展生存期(PFS)及总生存期(OS)。采用Kaplan-Meier法绘制生存曲线并行log-rank检验,采用Cox比例风险模型行单因素和多因素分析。结果 对照组、巩固化疗组ORR分别为44.71%(38/85)、66.67%(36/54),差异有统计学意义(χ2=5.54,P=0.018);DCR分别为70.59%(60/85)、87.04%(47/54),差异有统计学意义(χ2=5.04,P=0.025)。两组患者中位PFS分别为9.0、13.1个月,差异有统计学意义(χ2=12.74,P<0.001);中位OS分别为15.0、20.6个月,差异有统计学意义(χ2=24.75,P<0.001)。两组cT3-4N1-3M0亚组ESCC患者中位OS分别为16.0、30.8个月,差异有统计学意义(χ2=23.49,P<0.001)。单因素分析显示,肿瘤长度(HR=1.57,95%CI为1.04~2.36,P=0.032)、客观缓解(HR=0.08,95%CI为0.04~0.17,P<0.001)、巩固化疗(HR=0.32,95%CI为0.20~0.51,P<0.001)均是Ⅲ~ⅣA期行根治性放化疗后ESCC患者OS的影响因素。多因素分析显示,肿瘤长度(HR=1.59,95%CI为1.05~2.43,P=0.030)、客观缓解(HR=0.05,95%CI为0.02~0.10,P<0.001)、巩固化疗(HR=0.22,95%CI为0.13~0.36,P<0.001)均是Ⅲ~ⅣA期行放化疗后ESCC患者OS的独立影响因素。安全性方面,巩固化疗组发生7例不良反应,主要有消化道反应、白细胞降低,其中1~2级5例、3~4级2例;对照组发生22例不良反应,主要有中性粒细胞减少、血小板减少、贫血、消化道反应,其中1~2级16例,3~4级6例。两组不良反应总发生率分别为12.96%(7/54)、25.88%(22/85),差异无统计学意义(χ2=3.34,P=0.068)。结论 Ⅲ~ⅣA期ESCC患者放化疗后行巩固化疗可显著改善预后,且总体不良反应可控。

关键词: 食道鳞癌, 化放疗, 维持化疗, 治疗结果, 预后

Abstract:

Objective To explore the efficacy of consolidation chemotherapy after radical radiotherapy and chemotherapy in stage Ⅲ-ⅣA esophageal squamous cell carcinoma (ESCC) patients in the real world. Methods The clinical data of 139 patients with stage Ⅲ-ⅣA ESCC who underwent radical radiotherapy and chemotherapy from January 1, 2018 to December 31, 2022 in Hefei Cancer Hospital, Chinese Academy of Sciences were retrospectively analyzed. Patients were divided into a control group (n=85) and a consolidation chemotherapy group (n=54) based on whether they underwent consolidation chemotherapy after radical radiotherapy and chemotherapy. The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) between the two groups were compared. The Kaplan-Meier method was used to draw survival curves and log-rank tests were conducted. The Cox proportional risk model was used for univariate and multivariate analysis. Results The ORR of the control group and the consolidation chemotherapy group were 44.71% (38/85) and 66.67% (36/54), respectively, with a statistically significant difference (χ2=5.54, P=0.018); the DCR were 70.59% (60/85) and 87.04% (47/54), respectively, with a statistically significant difference (χ2=5.04, P=0.025). The median PFS of the two groups of patients were 9.0 and 13.1 months, respectively, with a statistically significant difference (χ2=12.74, P<0.001); the median OS were 15.0 and 20.6 months, respectively, with a statistically significant difference (χ2=24.75, P<0.001). The median OS of ESCC patients in two subgroups of cT3-4N1-3M0 were 16.0 and 30.8 months, respectively, with a statistically significant difference (χ2=23.49, P<0.001). Univariate analysis showed that tumor length (HR=1.57, 95%CI: 1.04-2.36, P=0.032), objective response (HR=0.08, 95%CI: 0.04-0.17, P<0.001), and consolidation chemotherapy (HR=0.32, 95%CI: 0.20-0.51, P<0.001) were all influencing factors for OS in ESCC patients undergoing radical radiotherapy and chemotherapy in stages Ⅲ-ⅣA. Multivariate analysis showed that tumor length (HR=1.59, 95%CI: 1.05-2.43, P=0.030), objective response (HR=0.05, 95%CI: 0.02-0.10, P<0.001), and consolidation chemotherapy (HR=0.22, 95%CI: 0.13-0.36, P<0.001) were all independent influencing factors for OS in stage Ⅲ-ⅣA ESCC patients undergoing radiotherapy and chemotherapy. In terms of safety, the consolidation chemotherapy group experienced 7 adverse reactions mainly gastrointestinal reaction and leukopenia, including 5 cases of grade 1-2 and 2 cases of grade 3-4; 22 cases of adverse reactions occurred in the control group including 16 cases of grade 1-2 and 6 cases of grade 3-4 mainly including neutropenia, thrombocytopenia, anemia and digestive tract reaction. The incidence rates of adverse reactions in the two groups were 12.96% (7/54) and 25.88% (22/85), respectively, with no statistically significant difference (χ2=3.34, P=0.068). Conclusion After radical radiotherapy and chemotherapy, consolidation chemotherapy can significantly improve the prognosis of stage Ⅲ-ⅣA ESCC patients, and the overall adverse reactions are controllable.

Key words: Esophageal squamous cell carcinoma, Chemoradiotherapy, Maintenance chemotherapy, Treatment outcome, Prognosis