Bedenne L, Seitz J F, Milan C, Renard P, Fraisse J, Conroy T, Lacourt J, Janoray P, Faivre J
Service d'Hépato-Gastroentérologie, CHU Le Bocage, Dijon.
Gastroenterol Clin Biol. 1998 Mar;22(3):273-81.
The aim of this study was to analyze the efficacy and tolerance of preoperative radiochemotherapy in esophageal squamous cell carcinoma. Patterns of recurrence and prognostic factors were also studied.
This multicentric phase II trial included patients deemed operable. Preoperative treatment associated 5-FU 800 mg/m2/d by continuous infusion, cisplatin 20 mg/m2/d and radiotherapy 3 Gy/d D 1-5 and D 22-26. Resection was planned 50 to 60 days after the beginning of therapy.
Seventeen centers accrued 96 patients, mean age 55.4 years. According to UICC 1978 classification: stage I 13%, stage II 53% and stage III 30%. Mean follow-up was 73 months. Pre-operative treatment was delivered at full dose in half of the patients. Ten percent of the patients did not receive the second cycle. Toxicity reached grade 3 in 23% and grade 4 in 7% of the patients. Two preoperative deaths occurred. Curative resection was performed in 82% of the patients. Operative mortality was 9%. tumors were sterilized on the operative specimen in 20% of the patients and microscopic remnants were observed in 13%. Preoperative clinical work-up overestimated histologic response in 10% of the cases underestimated it in 29%. After 2 years, a recurrence was observed in 56% of the patients: loco-regional in 30%, metastases in 19% and both in 7%. Median survival was 17 months and survival rates were 58% at 1 year and 25% at 5 years. Four prognostic factors influenced survival in multivariate analysis (Cox model): hematological toxicity grade 3 or 4, no complete response, circumferential extension > 2/3 and nodes visible on CT-scan. Factors positively influencing complete response were in multivariate analysis: a fungating tumor, weight loss < 8% and a full dose preoperative treatment.
In this study, preoperative treatment associating 5-FU-cisplatin and radiotherapy allowed a high resectability rate, with one third of patients achieving complete or nearly complete histologic response. A randomized study is warranted to know whether this combined treatment is better than surgery alone.
本研究旨在分析术前放化疗在食管鳞状细胞癌中的疗效和耐受性。同时也研究了复发模式和预后因素。
这项多中心II期试验纳入了被认为可手术的患者。术前治疗采用持续输注5-氟尿嘧啶800mg/m²/d、顺铂20mg/m²/d，并在第1 - 5天和第22 - 26天给予3Gy/d的放疗。计划在治疗开始后50至60天进行手术切除。
17个中心共纳入96例患者，平均年龄55.4岁。根据UICC 1978年分类：I期13%，II期53%，III期30%。平均随访73个月。一半的患者接受了全剂量的术前治疗。10%的患者未接受第二个周期的治疗。23%的患者毒性达到3级，7%的患者达到4级。发生了2例术前死亡。82%的患者进行了根治性切除。手术死亡率为9%。20%的患者手术标本上肿瘤被清除，13%观察到镜下残留。术前临床检查在10%的病例中高估了组织学反应，在29%的病例中低估了组织学反应。2年后，56%的患者出现复发：局部区域复发30%，远处转移19%，两者均有7%。中位生存期为17个月，1年生存率为58%，5年生存率为25%。多因素分析（Cox模型）中四个预后因素影响生存：血液学毒性3级或4级、无完全缓解、周向扩展>2/3以及CT扫描可见淋巴结。多因素分析中对完全缓解有积极影响的因素为：溃疡型肿瘤、体重减轻<8%以及全剂量术前治疗。
在本研究中，5-氟尿嘧啶-顺铂联合放疗的术前治疗可获得较高的切除率，三分之一的患者实现了完全或近乎完全的组织学反应。有必要进行一项随机研究以了解这种联合治疗是否优于单纯手术。
