食道通结颗粒联合化疗对Ⅱb-Ⅲc期食管鳞癌根治术后患者无病生存期的影响
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摘要
目的研究食道通结颗粒联合化疗对Ⅱb-Ⅲc期食管鳞癌根治术后患者无病生存期(disease-free survival,DFS)的影响。方法采用前瞻性、随机对照的研究方法,将106例Ⅱb-Ⅲc期食管鳞癌根治术后患者分为中药联合化疗组(51例)和单纯化疗组(55例),应用Kaplan-Meier法估算两组患者的DFS及1年、2年、3年的无病生存率,并对可能影响患者DFS的因素进行Log-rank单因素分析,在单因素分析的基础上通过Cox比例风险模型对DFS相关的预后因素进行多因素分析。结果①中药联合化疗组和单纯化疗组患者的中位DFS分别为34.6个月、23.2个月,差异有统计学意义(P<0.05)。②中药联合化疗组1年、2年、3年的无病生存率分别为76.5%、58.0%、42.2%,单纯化疗组1年、2年、3年的无病生存率分别为72.7%、45.4%、32.4%。③Log-rank单因素分析显示,淋巴结的侵犯范围、TNM分期、有无脉管癌栓以及是否联合中药治疗是影响患者DFS的预后因素。④Cox多因素分析显示,有无脉管癌栓以及是否联合中药治疗是影响Ⅱb-Ⅲc期食管鳞癌根治术后患者DFS的独立预后因素。结论食道通结颗粒联合化疗能延长Ⅱb-Ⅲc期食管鳞癌根治术后化疗患者的DFS,有无脉管癌栓以及是否联合中药治疗是影响患者DFS的独立预后因素。
Objective To investigate the effects of Shidao Tongjie Granules combined with chemotherapy on disease-free survival(DFS) in the treatment of esophageal squamous cell carcinoma(ESCC) at stage ⅡB-ⅢC after radical resection. Methods A prospective, randomized, controlled study was performed in 106 patients with ESCC at stage ⅡB-ⅢC after radical resection. The patients were randomly assigned into traditional Chinese medicine(TCM) + chemotherapy(TCM+CT) group(n=51) and chemotherapy(CT) group(n=55). DFS and 1-, 2-and 3-year DFS rates were calculated by Kaplan-Meier method in both groups. A log-rank univariate analysis was performed on factors with possible impact on DFS, and a multivariate analysis was carried out on the DFS-related prognosis factors using Cox proportional hazard model based on results of the univariate analysis. Results ①The median DFS was 34.6 and 23.3 months in the TCM+CT group and the CT group respectively, with statistically significant difference between the groups(P<0.05). ②The 1-, 2-and 3-year DFS rates were 76.5%, 58.0% and 42.2% in the TCM+CT group respectively, and 72.7%, 45.4% and 32.4% in the CT+TCM group respectively. ③The results of log-rank univariate analysis showed that scope of lymph node invasion, TNM staging, presence or absence of vascular cancer emboli and whether or not combined with TCM were the prognosis factors of DFS. ④The results of Cox multivariate analysis showed presence or absence of vascular cancer emboli and whether or not combined with TCM were the independent prognosis factors of DFS in patients with ESCC at stage ⅡB-ⅢC after radical resection. Conclusion Shidao Tongjie Granules in combination with chemotherapy prolongs DFS,and presence or absence of vascular cancer emboli and whether or not combined with TCM are the independent prognostic factors of DFS in patients with ESCC at stage ⅡB-ⅢC after radical resection.
Objective To investigate the effects of Shidao Tongjie Granules combined with chemotherapy on disease-free survival(DFS) in the treatment of esophageal squamous cell carcinoma(ESCC) at stage ⅡB-ⅢC after radical resection. Methods A prospective, randomized, controlled study was performed in 106 patients with ESCC at stage ⅡB-ⅢC after radical resection. The patients were randomly assigned into traditional Chinese medicine(TCM) + chemotherapy(TCM+CT) group(n=51) and chemotherapy(CT) group(n=55). DFS and 1-, 2-and 3-year DFS rates were calculated by Kaplan-Meier method in both groups. A log-rank univariate analysis was performed on factors with possible impact on DFS, and a multivariate analysis was carried out on the DFS-related prognosis factors using Cox proportional hazard model based on results of the univariate analysis. Results ①The median DFS was 34.6 and 23.3 months in the TCM+CT group and the CT group respectively, with statistically significant difference between the groups(P<0.05). ②The 1-, 2-and 3-year DFS rates were 76.5%, 58.0% and 42.2% in the TCM+CT group respectively, and 72.7%, 45.4% and 32.4% in the CT+TCM group respectively. ③The results of log-rank univariate analysis showed that scope of lymph node invasion, TNM staging, presence or absence of vascular cancer emboli and whether or not combined with TCM were the prognosis factors of DFS. ④The results of Cox multivariate analysis showed presence or absence of vascular cancer emboli and whether or not combined with TCM were the independent prognosis factors of DFS in patients with ESCC at stage ⅡB-ⅢC after radical resection. Conclusion Shidao Tongjie Granules in combination with chemotherapy prolongs DFS,and presence or absence of vascular cancer emboli and whether or not combined with TCM are the independent prognostic factors of DFS in patients with ESCC at stage ⅡB-ⅢC after radical resection.
引文
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[9] 杨茜雯,张铭,金长娟,等.食道通结方辅助化疗对中晚期食管癌鳞癌患者生存期及免疫功能的影响[J].中医杂志,2017,58(21):1838- 1841.
[10] 董昀,张铭,金长娟,等.食道通结方对食管癌裸鼠移植瘤细胞增殖及凋亡的影响[J].上海中医药大学学报,2018,32(4):70- 74
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[12] ZHANG H,CHEN X,WANG S,et al.Poorer prognosis associated with simultaneous lymphatic and vascular invasion in patients with squamous carcinoma of the thoracic oesophagus[J].Eur J Cardiothorac Surg,2017,52(2):378- 384.
[2] 李学民,汤萨,彭秀青,等.1973—2005年手术治疗食管癌患者5年生存率变化分析[J].肿瘤防治研究,2014,41(3):237- 242.
[3] CHEN J G,CHEN H Z,ZHU J,et al.Cancer survival in patients from a hospital- based cancer registry,China[J].J Cancer,2018,9(5):851- 860.
[4] EDGE S B,BYRD D R,COMPTON C C,et al.AJCC Cancer Staging Manual[M].7th ed.New York:Springer- Verlag,2009:103- 115
[5] 上海市卫生局.上海市中医病证诊疗常规[M].2版.上海:上海中医药大学出版社,2002:20- 22.
[6] NAKAGAW S,KANDA T,KOSUGI S,et al.Recurrence pattern of squamous cell carcinoma of the thoracic esophagus after extended radical esophagectomy with three- field lymphadenectomy[J].J Am Coll Surg,2004,198(2):205- 211.
[7] 吴成亚,冯颖,李杰.基于循证医学的中医药治疗食管癌作用特点研究概述[J].山东中医杂志,2016,35(12):1092- 1095.
[8] 蔡霄月,杨茜文,卢文峰,等.食道通结颗粒联合化疗治疗中晚期食管癌的近期疗效观察[J].上海中医药杂志,2017,51(7):44- 47.
[9] 杨茜雯,张铭,金长娟,等.食道通结方辅助化疗对中晚期食管癌鳞癌患者生存期及免疫功能的影响[J].中医杂志,2017,58(21):1838- 1841.
[10] 董昀,张铭,金长娟,等.食道通结方对食管癌裸鼠移植瘤细胞增殖及凋亡的影响[J].上海中医药大学学报,2018,32(4):70- 74
[11] WANG S,CHEN X,FAN J,et al.Prognostic significance of lymphovascular invasion for thoracic esophageal squamous cell carcinoma[J].Ann Surg Oncol,2016,23(12):4101- 4109
[12] ZHANG H,CHEN X,WANG S,et al.Poorer prognosis associated with simultaneous lymphatic and vascular invasion in patients with squamous carcinoma of the thoracic oesophagus[J].Eur J Cardiothorac Surg,2017,52(2):378- 384.