Surgery alone versus chemoradiotherapy followed by surgery for resectable cancer of the oesophagus: a randomised controlled phase III trial

被引:752
作者
Burmeister, BH [1 ]
Smithers, BM
Gebski, V
Fitzgerald, L
Simes, RJ
Devitt, P
Ackland, S
Gotley, DC
Joseph, D
Millar, J
North, J
Walpole, ET
Denham, JW
机构
[1] Univ Queensland, Princess Alexandra Hosp, Woolloongabba, Qld 4102, Australia
[2] NHMRC, Clin Trials Ctr, Sydney, NSW, Australia
[3] Royal Adelaide Hosp, Adelaide, SA 5000, Australia
[4] Mater Hosp Newcastle, Newcastle, NSW, Australia
[5] Sir Charles Gairdner Hosp, Perth, WA, Australia
[6] Alfred Hosp, Melbourne, Vic, Australia
[7] Dunedin Publ Hosp, Dunedin, New Zealand
基金
英国医学研究理事会;
关键词
D O I
10.1016/S1470-2045(05)70288-6
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background 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. Methods 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. Findings Neither progression-free survival nor overall survival differed between groups (hazard ratio [HR] 0.82 [95% CI 0.61-1.101 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. Interpretation 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 squamouscell tumours.
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收藏
页码:659 / 668
页数:10
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