术前放化疗并手术治疗局部晚期食管癌Ⅱ期临床试验

Chemoradiotherapy followed by Surgery in Treatment of Locally Advanced Esophag eal Carcinoma:A Phase ⅡTrial

背景与目的:研究表明:术前放疗仅能提高切除率,不能延长生存期,术前化疗亦未证实能提高生存率。目前,应用术前放化疗拟提高食管癌的生存率、减少局部复发率成为研究的热点。本研究的目的是评价局部晚期食管鳞癌患者对术前放化疗并手术的耐受性,术前放化疗的近期疗效以及对肿瘤切除率、术后并发症发生率、围术期死亡率的影响。方法:2000年1月～2003年9月连续收治符合入组条件的局部晚期食管鳞癌患者34例,应用胸部及腹部CT、食管超声内镜(EUS)、支气管内镜检查等进行治疗前分期。术前放化疗方案:盖诺25mg/m2第1、8、22、29天静脉注射,或5-FU2.4g/m2,第1～3、22～25天持续72h静脉输注;DDP75mg/m2第1、22天静脉滴注。同期采用常规分割放疗40Gy。放化疗结束3～5周后施行食管癌切除,重建消化道。结果:全组34例,其中33例完成术前放化疗,32例进一步接受手术。术前放化疗引起的骨髓抑制、肺毒性、食管毒性,多数为Ⅰ～Ⅱ度,无术前放化疗的毒副反应导致无法手术或死亡。术前放化疗的临床有效率85.3%,病理完全缓解率25%。手术切除率100%。术后肺部感染,吻合口瘘、围术期死亡率分别是22.9%、9.4%、6.3%。结论:本治疗方案,患者耐受性良好,但放化疗的毒副反应不容忽视,围术期并发症发生率及死亡率升高。术前放化疗可以?

BACKGROUND &OBJECTIVE: Recently, neoadjuvant therapy has become th e focus of interest in an effort to prolong survival and reduce recurrence rates in patients with oesophageal cancer. This study was designed to evaluate the to lerance and the short-term outcome of chemoradiotherapy followed by surgery for patients with locally advanced esophageal squamous carcinoma, to observe effect s of chemoradiotherapy on tumor resection rate, incidence of complications after surgery, and perioperative mortality. METHODS: From January 2000 to September 2 003, Thirty-four consecutive patients with locally advanced esophageal squamous carcinoma were entered into this phase II study. The clinical pre-treatment st aging of the tumors were determined by chest CT scan, abdomial CT Scan, EUS, and bronchoscopy examination. Chemotherapy and radiotherapy were performed concurre ntly. The chemotherapy consisted of Vinorelbine (or 5-Fluorouracil) and Cisplat in. 5-Fluorouracil at 2.4 g/m2 was administered in continuous infusion for days 1-3 and days 22-25. Vinorelbine at 25mg/m2 per day was administered in bolus infusion on d1、d8、d22 and d29. Cisplatin at 75 mg/m2 was administered by intra venously infusion on d1 and d22. A total radiotherapy dose of 40 Gy was delivere d in 20 daily fractions of 2.0 Gy each (given 5 d/wk for 4 weeks). After complet ion of chemoradiotherapy, clinical restaging was performed. Esophagectomy and ly mphadenectomies were performed 3-5 weeks after chemoradiotherapy. RESULTS: Thir ty-three patients completed the planned chemoradiotherapy, and 32 patients unde rwent surgery. The toxicities of chemoradiotherapy such as myelotoxicity, pulmon ary toxicity, esophagitis were grade Ⅰor Ⅱ. No death was resulted from chemora diotherapy. The clinical response rate of chemoradiotherapy was 85.3%, the path ological complete response rate was 25%, the resectability rate was 100%.Posto perative pulmonary infection occurred in 8 patients(22.9%),anastomotic leak i n 3 patients(9.4%). Two patients (6.3%) died perioperatively because of ARDS a nd anastomotic leak complicated with heart failure. CONCLUSIONS: The short-term results of this study suggest that the strategy of chemoradiotherapy followed b y surgery is safe,although it caused considerable toxicity and increased operat ion-related complications rate and perioperative mortality rate compared with s urgery alone at the same period. Preoperative chemoradiotherapy is able to signi ficantly reduce the tumor stage, and achieve substantially high clinical respons e rate and pathological complete response rate.