Robertson A G, Soutar D S, Paul J, Webster M, Leonard A G, Moore K P, McManners J, Yosef H M, Canney P, Errington R D, Hammersley N, Singh R, Vaughan D
Beatson Oncology Centre, Western Infirmary, Glasgow, UK.
Clin Oncol (R Coll Radiol). 1998;10(3):155-60. doi: 10.1016/s0936-6555(98)80055-1.
Tumours of the oral cavity/oropharynx occur relatively infrequently in the UK. The management of such lesions, especially the squamous cell carcinomas, is still a little controversial. Some centres advocate radiotherapy while others adopt surgery and radiotherapy. In an attempt to resolve the question of which approach gives the better results, a multicentre randomized trial was established to compare surgery plus postoperative radiotherapy with radical radiotherapy alone. It was anticipated that 350 patients would be required to give a statistically significant result, but, after 35 patients had been entered, the trial was closed prematurely with a marked difference in overall survival in favour of the combination arm (P = 0.0006). At this analysis, carried out 23 months after trial closure, the survival difference between the two arms remains statistically significant for all causes of mortality (P = 0.001; relative death rate = 0.24; 95% CI 0.10-0.59).
口腔/口咽肿瘤在英国相对较少见。此类病变的治疗，尤其是鳞状细胞癌，仍存在一定争议。一些中心主张放疗，而另一些则采用手术加放疗。为了确定哪种方法效果更好，开展了一项多中心随机试验，比较手术加术后放疗与单纯根治性放疗。预计需要350名患者才能得出具有统计学意义的结果，但在纳入35名患者后，试验提前结束，联合治疗组的总生存率有显著差异（P = 0.0006）。在试验结束23个月后进行的此次分析中，两组之间因各种原因导致的死亡率差异在统计学上仍具有显著性（P = 0.001；相对死亡率 = 0.24；95%置信区间0.10 - 0.59）。
