Sasako M, Saka M, Fukagawa T, Katai H, Sano T
Gastric Surgery Division, National Cancer Center Hospital, Tokyo, Japan.
Dig Surg. 2007;24(2):101-7. doi: 10.1159/000101896. Epub 2007 Apr 19.
The results of clinical trials regarding surgery of curable advanced gastric cancer and esophagogastric junction (EGJ) tumors are reviewed and summarized. Four clinical trials have evaluated D2 dissection for curable gastric cancer in the West. Two large trials in the UK and the Netherlands failed to prove the efficacy of D2 dissection. However, these trials had critical weak points. As they were carried out in a number of hospitals where there was no experience with this surgery, the quality of surgery and postoperative care were very poor making the hospital mortality unacceptably high. After these trials, an Italian group started a phase II study in 8 hospitals with a relatively high volume to confirm the safety of this procedure for Caucasians. They achieved 3% mortality, which was much smaller than that of even D1 in the former trials. These results first highlighted the importance of learning and hospital volume in D2 dissection. Survival results of the Dutch trial showed some difference between D1 and D2, but the difference was not statistically significant. This was attributed to the high hospital mortality and poor quality of surgery, especially low compliance of D2 and the high rate of extension of D1, making this comparison similar to that between D1.3 and D1.7. The results of the phase III study by the Italian group are awaited. Recently a Taiwanese trial proved the benefit of D2 dissection over D1 in a phase III trial. This was a single institutional trial with a sample size of 221 patients. The 5-year survival rate of D2 and D1 was 59.5 and 53.6%, respectively (p = 0.04). The Dutch trials for EGJ tumors showed a large difference in overall survival between the transthoracic and transhiatal approach for Siewert type 1 and 2 tumors, but this was not statistically significant, most likely due to the small sample size. In the subgroup analysis, they demonstrated that there was no survival difference in Siewert type 2 but a large difference in Siewert type 1. A Japanese study showed that there is no benefit to the thoraco-abdominal approach over the transhiatal approach for EGJ tumors whose invasion in the esophagus is 3 cm or less. These two trials clearly demonstrated that mediastinal dissection through a right thoracotomy is recommendable for Siewert type 1, while the transhiatal approach should be considered as standard for Siewert type 2.
本文回顾并总结了关于可治愈性进展期胃癌及食管胃交界（EGJ）肿瘤手术的临床试验结果。西方有四项临床试验评估了可治愈性胃癌的D2根治术。英国和荷兰的两项大型试验未能证实D2根治术的疗效。然而，这些试验存在关键弱点。由于试验在一些没有该手术经验的医院进行，手术质量和术后护理很差，导致医院死亡率高得难以接受。在这些试验之后，一个意大利团队于8家手术量相对较高的医院开展了一项II期研究，以确认该手术对高加索人的安全性。他们实现了3%的死亡率，这甚至比之前试验中D1根治术的死亡率还要低。这些结果首次凸显了D2根治术中学习曲线和医院手术量的重要性。荷兰试验的生存结果显示D1和D2之间存在一些差异，但差异无统计学意义。这归因于医院死亡率高和手术质量差，尤其是D2根治术的依从性低以及D1根治术的扩大率高，使得这种比较类似于D1.3和D1.7之间的比较。意大利团队的III期研究结果有待公布。最近，一项台湾的试验在III期试验中证明了D2根治术优于D1根治术。这是一项单中心试验，样本量为221例患者。D2和D1根治术的5年生存率分别为59.5%和53.6%（p = 0.04）。荷兰针对EGJ肿瘤的试验显示，对于Siewert 1型和2型肿瘤，经胸和经腹途径的总生存率存在较大差异，但差异无统计学意义，很可能是由于样本量小。在亚组分析中，他们表明Siewert 2型肿瘤的生存率无差异，但Siewert 1型肿瘤存在较大差异。一项日本研究表明，对于食管侵犯3 cm及以下的EGJ肿瘤，胸腹联合途径并不比经腹途径更具优势。这两项试验清楚地表明，对于Siewert 1型肿瘤，推荐通过右胸切开进行纵隔清扫，而对于Siewert 2型肿瘤，应将经腹途径视为标准术式。
