Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Clinical Research Institute, Cancer Biostatistics Laboratory, National Kyushu Cancer Center, Fukuoka, Japan.
Surgery. 2019 Mar;165(3):586-592. doi: 10.1016/j.surg.2018.08.027. Epub 2018 Oct 9.
Lateral lymph node dissection has been 1 of the standard treatments for mid and ow rectal cancer in Japan. The aim of this ad-hoc analysis was to evaluate the impact of lateral lymph node dissection on outcomes in the randomized clinical trial, referred to as the Adjuvant Chemotherapy for Stage II/III Rectal Cancer trial.
The Adjuvant Chemotherapy for Stage II/III Rectal Cancer trial was a randomized, phase III trial of adjuvant chemotherapy of 2 different oral fluoropyrimidines; 445 patients with lower rectal cancer were studied in this ad-hoc analysis out of 959 patients in total, 215 of whom underwent lateral lymph node dissection and 230 did not.
There were no significant differences in background characteristics of the patients in the group, except for in age and number of dissected lymph nodes, between the lateral lymph node dissection and without lateral lymph node dissection groups. The age of the younger patients was often used to select candidates for lateral lymph node dissection (lateral lymph node dissection versus non-lateral lymph node dissection; 63.5 ± 8.9 vs 60.7 ± 9.4 [P = .0017]). Lateral lymph node dissection had no impact on relapse-free survival (hazard ratio = 0.941, 95% confidence interval: 0.696-1.271) or overall survival (hazard ratio = 0.858, 95% confidence interval: 0.601-1.224) in all patients with mid and low rectal cancer. In subset analysis, lateral lymph node dissection improved relapse-free survival in female patients and in patients with stage B/C or N3/4 disease. For cumulative recurrence across all patients, the proportion of patients with distant recurrence was slightly greater in the lateral lymph node dissection group but there was no difference in local recurrence.
This exploratory analysis did not show that lateral lymph node dissection improves relapse-free survival and overall survival in patients with mid and low rectal cancer. Lateral lymph node dissection may, however, have a prognostic impact on patients with highly invasive rectal cancer.
在日本，侧方淋巴结清扫术一直是中低位直肠癌的标准治疗方法之一。本探索性分析旨在评估侧方淋巴结清扫术对随机临床试验（即辅助化疗治疗 II/III 期直肠癌试验）结果的影响。
辅助化疗治疗 II/III 期直肠癌试验是一项比较两种不同口服氟嘧啶辅助化疗的随机 III 期临床试验。总共纳入了 959 例患者，其中 445 例为低位直肠癌患者，本探索性分析纳入了其中 215 例行侧方淋巴结清扫术和 230 例未行侧方淋巴结清扫术的患者。
在侧方淋巴结清扫术组和未行侧方淋巴结清扫术组之间，患者的背景特征除年龄和清扫淋巴结数量外，无显著差异。年轻患者的年龄常用于选择侧方淋巴结清扫术的候选者（侧方淋巴结清扫术组与未行侧方淋巴结清扫术组相比；63.5±8.9 岁比 60.7±9.4 岁[P=0.0017]）。侧方淋巴结清扫术对中低位直肠癌患者的无复发生存（风险比=0.941，95%置信区间：0.696-1.271）或总生存（风险比=0.858，95%置信区间：0.601-1.224）均无影响。在亚组分析中，侧方淋巴结清扫术改善了女性患者和 II/III 期或 N3/4 期患者的无复发生存。对于所有患者的累积复发，侧方淋巴结清扫术组远处复发的患者比例略高，但局部复发无差异。
本探索性分析并未显示侧方淋巴结清扫术可改善中低位直肠癌患者的无复发生存和总生存。然而，侧方淋巴结清扫术可能对侵袭性较高的直肠癌患者具有预后影响。
