Burmeister Bryan H, Smithers B Mark, Gebski Val, Fitzgerald Lara, Simes R John, Devitt Peter, Ackland Stephen, Gotley David C, Joseph David, Millar Jeremy, North John, Walpole Euan T, Denham James W
University of Queensland, Princess Alexandra Hospital, Brisbane, Australia.
Lancet Oncol. 2005 Sep;6(9):659-68. doi: 10.1016/S1470-2045(05)70288-6.
Resection remains the best treatment for carcinoma of the oesophagus in terms of local control, but local recurrence and distant metastasis remain an issue after surgery. We aimed to assess whether a short preoperative chemoradiotherapy regimen improves outcomes for patients with resectable oesophageal cancer.
128 patients were randomly assigned to surgery alone and 128 patients to surgery after 80 mg/m(2) cisplatin on day 1, 800 mg/m(2) fluorouracil on days 1-4, with concurrent radiotherapy of 35 Gy given in 15 fractions. The primary endpoint was progression-free survival. Secondary endpoints were overall survival, tumour response, toxic effects, patterns of failure, and quality of life. Analysis was done by intention to treat.
Neither progression-free survival nor overall survival differed between groups (hazard ratio [HR] 0.82 [95% CI 0.61-1.10] and 0.89 [0.67-1.19], respectively). The chemoradiotherapy-and-surgery group had more complete resections with clear margins than did the surgery-alone group (103 of 128 [80%] vs 76 of 128 [59%], p=0.0002), and had fewer positive lymph nodes (44 of 103 [43%] vs 69 of 103 [67%], p=0.003). Subgroup analysis showed that patients with squamous-cell tumours had better progression-free survival with chemoradiotherapy than did those with non-squamous tumours (HR 0.47 [0.25-0.86] vs 1.02 [0.72-1.44]). However, the trial was underpowered to determine the real magnitude of benefit in this subgroup.
Preoperative chemoradiotherapy with cisplatin and fluorouracil does not significantly improve progression-free or overall survival for patients with resectable oesophageal cancer compared with surgery alone. However, further assessment is warranted of the role of chemoradiotherapy in patients with squamous-cell tumours.
就局部控制而言，手术切除仍是食管癌的最佳治疗方法，但术后局部复发和远处转移仍是问题。我们旨在评估短期术前放化疗方案是否能改善可切除食管癌患者的预后。
128例患者被随机分配至单纯手术组，128例患者在第1天接受80mg/m²顺铂、第1 - 4天接受800mg/m²氟尿嘧啶治疗，并同时接受15次分割共35Gy的放疗后再行手术。主要终点是无进展生存期。次要终点包括总生存期、肿瘤反应、毒性作用、失败模式和生活质量。分析采用意向性治疗。
两组间无进展生存期和总生存期均无差异（风险比[HR]分别为0.82[95%可信区间0.61 - 1.10]和0.89[0.67 - 1.19]）。放化疗联合手术组与单纯手术组相比，切缘阴性的完整切除例数更多（128例中的103例[80%]对128例中的76例[59%]，p = 0.0002），阳性淋巴结更少（103例中的44例[43%]对103例中的69例[67%]，p = 0.003）。亚组分析显示，鳞状细胞肿瘤患者接受放化疗后的无进展生存期优于非鳞状细胞肿瘤患者（HR 0.47[0.25 - 0.86]对1.02[0.72 - 1.44]）。然而，该试验的效能不足以确定该亚组中实际的获益程度。
与单纯手术相比，术前使用顺铂和氟尿嘧啶进行放化疗并不能显著改善可切除食管癌患者的无进展生存期或总生存期。然而，有必要进一步评估放化疗在鳞状细胞肿瘤患者中的作用。
