食管鳞癌新辅助放化疗术后化疗疗效分析

Clinical efficacy of postoperative chemotherapy for esophageal squamous cell cancer after preoperative chemoradiotherapy combined with surgery

目的 评价新辅助放化疗后可切除局部晚期食管鳞癌患者术后化疗的临床疗效.方法 收集郑州大学附属肿瘤医院2005-01-01-2012-12-31接受新辅助放化疗加手术的192例局部晚期食管鳞癌患者,术前化疗共2个周期,方案为顺铂20 mg/（m2·d）和氟尿嘧啶400 mg/（m2·d）持续静脉滴入5d,同步放疗剂量为40 Gy/20次,所有患者均成功接受手术.患者分组依据术前新辅助放化疗过程中出现的骨髓抑制程度,出现2度及以上骨髓抑制的122例患者术后未再接受其他治疗,即单纯新辅助放化疗加手术（A组）;未出现2度及以上骨髓抑制的70例患者均接受术后化疗,即新辅助放化疗加手术结合术后化疗（B组）.B组患者术后接受1～4个周期的化疗,方案同术前化疗.结果 A组1、3和5年总生存率分别为87.4％、51.9％和43.5％,B组分别为93.0％ 、58.5％和48.8％,两组5年生存率差异无统计学意义,x2=1.390,P=0.238.A组和B组5年无疾病进展生存率分别为34.0％和38.8％,差异有统计学意义,x2 =3.883,P=0.049. Cox分析结果显示,病理完全缓解（HR=1.420,95％CI为1.074～1.878,P=0.014,及淋巴结病理阴性（HR=1.979,95％CI为1.221～3.209,P=0.006）与较高的总体生存率相关,而且病理完全缓解（HR=1.273,95％CI为0.994～1.631,P=0.056,及淋巴结病理阴性（HR=1.753,95％CI为1.121～2.742,P=0.004）与较高的无疾病进展生存率亦相关.亚组分析显示,男性和未完全病理缓解患者的无疾病进展生存率从术后化疗中获益较多.结论 术后化疗不能提高新辅助放化疗后可切除的局部晚期食管鳞癌的总体生存率,但可以提高该部分患者的无疾病进展生存率,尤其是男性及新辅助放化疗后未完全病理缓解的患者.

OBJECTIVE To assess the clinical outcome of postoperative chemotherapy for resectable locally ad- vanced esophageal squamous cell cancer （ESCC） after preoperative chemoradiotherapy combined with surgery （trimodality therapy）. METHODS From January 1,2005 to December 31,2Q12,192 consecutive locally advanced ESCC patients who had undergone trimodality therapy successfully were included. Grouping was based on the degree of myelosuppression oc- curred during preoperative cbemoradiotherapy. Of the 192 patients, 120 patients underwent trimodality therapy only （group A）, while 72 patients received postoperative chemotherapy additionally after trimodality therapy （group B）. Preop- erative chemoradiotherapy included two cycles of chemotherapy concurrently with radiotherapy. The chemotherapy regi- men consisted of cisplatin 20 mg/（m2 · d） and fluorouracil 400 mg/（m2 · d） administered intravenously on days 1-5 of a 21-days cycle. Concurrent radiotherapy was delivered in a total of 40 Gy in 20 fractions. All patients underwent surgery successfully. For 72 patients in group B, additional 1 to 4 cycles of postoperative chemotherapy were administered and chemotherapy regimen was as before. RESULTS The 1,3 and 5-year overall survival （OS） rates were 87.4 %, 51.9% and 43.5% in group A,as compared with 93.0%,58.5%and 48.8% in the group B （X2=1. 390,P=0.238）. The 5-year progression-free survival （PFS） rates were 34.0% in group A and 38.8% in group B （X2 =3. 883,P=0. 049）. Outcome of Cox proportional-hazard regression model showed that complete pathological response（P=0. 014, HR= 1. 420,95%CI： 1. 074~ 1. 878） and negative lymph node （P = 0. 006, HR= 1. 979,95 % CI： 1. 221 ~ 3. 209）were associated with signifi- cantly improved OS. Likely, complete pathological response（P = 0.056, HR = 1. 273,95% CI 0. 994 ~ 1.631 ） and negative lymph node（P=0. 004, HR= 1. 753,95%CI： 1. 121~2. 742）were associated with improved PFS. Risk reduction in PFS was remarkable for males and those who did not achieve pathologic complete response （pCR）. CONCLUSION The addi- tion of postoperative chemotherapy demonstrates no overall survival benefit for patients with locally advanced ESCC, but PFS is significantly improved,especially for males and those who did not achieve pCR.