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【NEJM】胃癌D2淋巴结清扫根治术加与不加主动脉
ABSTRACT
Background Gastrectomy with D2 lymphadenectomy is the standard treatment for curable gastric cancer in eastern Asia. Whether the addition of para-aortic nodal dissection (PAND) to D2 lymphadenectomy for stage T2, T3, or T4 tumors improves survival is controversial. We conducted a randomized, controlled trial at 24 hospitals in Japan to compare D2 lymphadenectomy alone with D2 lymphadenectomy plus PAND in patients undergoing gastrectomy for curable gastric cancer.
Methods Between July 1995 and April 2001, 523 patients with curable stage T2b, T3, or T4 gastric cancer were randomly assigned during surgery to D2 lymphadenectomy alone (263 patients) or to D2 lymphadenectomy plus PAND (260 patients). We did not permit any adjuvant therapy before the recurrence of cancer. The primary end point was overall survival.
Results The rates of surgery-related complications among patients assigned to D2 lymphadenectomy alone and those assigned to D2 lymphadenectomy plus PAND were 20.9% and 28.1%, respectively (P=0.07). There were no significant differences between the two groups in the frequencies of anastomotic leakage, pancreatic fistula, abdominal abscess, pneumonia, or death from any cause within 30 days after surgery (the rate of death was 0.8% in each group). The median operation time was 63 minutes longer and the median blood loss was 230 ml greater in the group assigned to D2 lymphadenectomy plus PAND. The 5-year overall survival rate was 69.2% for the group assigned to D2 lymphadenectomy alone and 70.3% for the group assigned to D2 lymphadenectomy plus PAND; the hazard ratio for death was 1.03 (95% confidence interval [CI], 0.77 to 1.37; P=0.85). There were no significant differences in recurrence-free survival between the two groups; the hazard ratio for recurrence was 1.08 (95% CI, 0.83 to 1.42; P=0.56).
Conclusions As compared with D2 lymphadenectomy alone, treatment with D2 lymphadenectomy plus PAND does not improve the survival rate in curable gastric cancer.
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胃癌D2淋巴结清扫术加与不加主动脉旁淋巴结清扫术的比较
ABSTRACT
摘要
Background Gastrectomy with D2 lymphadenectomy is the standard treatment for curable gastric cancer in eastern Asia. Whether the addition of para-aortic nodal dissection (PAND) to D2 lymphadenectomy for stage T2, T3, or T4 tumors improves survival is controversial. We conducted a randomized, controlled trial at 24 hospitals in Japan to compare D2 lymphadenectomy alone with D2 lymphadenectomy plus PAND in patients undergoing gastrectomy for curable gastric cancer.
背景 在东亚，胃癌D2根治术是治疗有潜在治疗可能的胃癌的标准术式。对T2、T3以及T4期胃癌患者实施增加主动脉旁淋巴结清扫的D2根治术是否能提高生存率尚未达成共识。我们在日本24所医院进行了一项随机、对照研究，目的是为了比较增加了主动脉旁淋巴结清扫的D2根治术与标准D2根治术对可治疗胃癌的临床疗效。
Methods Between July 1995 and April 2001, 523 patients with curable stage T2b, T3, or T4 gastric cancer were randomly assigned during surgery to D2 lymphadenectomy alone (263 patients) or to D2 lymphadenectomy plus PAND (260 patients). We did not permit any adjuvant therapy before the recurrence of cancer. The primary end point was overall survival.
方法 把1995年7月至2001年4月收住的523例T2b、T3以及T4期胃癌患者随机的分成D2根治术组（263例）或者D2+PAND根治术组（260例）。在肿瘤复发前没有采用任何辅助治疗。主要目的是总的生存率。
Results The rates of surgery-related complications among patients assigned to D2 lymphadenectomy alone and those assigned to D2 lymphadenectomy plus PAND were 20.9% and 28.1%, respectively (P=0.07). There were no significant differences between the two groups in the frequencies of anastomotic leakage, pancreatic fistula, abdominal abscess, pneumonia, or death from any cause within 30 days after surgery (the rate of death was 0.8% in each group). The median operation time was 63 minutes longer and the median blood loss was 230 ml greater in the group assigned to D2 lymphadenectomy plus PAND. The 5-year overall survival rate was 69.2% for the group assigned to D2 lymphadenectomy alone and 70.3% for the group assigned to D2 lymphadenectomy plus PAND; the hazard ratio for death was 1.03 (95% confidence interval [CI], 0.77 to 1.37; P=0.85). There were no significant differences in recurrence-free survival between the two groups; the hazard ratio for recurrence was 1.08 (95% CI, 0.83 to 1.42; P=0.56).
结果 D2根治术组与D2+PAND根治术组手术相关并发症的发生率分别是20.9%与28.1%(P=0.07)。两组在吻合口漏、胰瘘、腹腔脓肿、肺炎的发生率与术后30天内任何原因导致的死亡率上没有显著差异（两组的手术死亡率均为0.8%）。D2+PAND根治术组的平均手术时间较D2根治术组长63分钟，，以及平均失血量较D2根治术组多230ml，。D2根治术组的5年生存率为69.2%，而D2+PAND根治术组为70.3%。死亡的危害比为1.03(95%的可信区间[CI], 0.77 -1.37; P=0.85)。两组的无复发生存率亦无显著差别。复发的危害比为1.03(95%的可信区间[CI], 0.83 -1.42; P=0.56)。
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作者:admin@医学,生命科学 2011-06-10 05:14
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