国际肿瘤学杂志

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:2023-08-18Revised:2024-03-06Online:2024-06-08Published:2024-06-28
  • Contact:Qian Xiaotao， Email： moranqxt@163.com

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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:

ObjectiveTo 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.MethodsThe 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.ResultsThe 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 cT3-4N1-3M0were 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）.ConclusionAfter 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