Eiji Oki1, Mototsugu Shimokawa2, Koji Ando3, Akihiko Murata4, Takao Takahashi5, Kiyoshi Maeda6, Tetsuya Kusumoto7, Yoshinori Munemoto8, Ryota Nakanishi3, Yuichiro Nakashima3, Hiroshi Saeki3, Yoshihiko Maehara3. 1. Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. Electronic address: okieiji@surg2.med.kyushu-u.ac.jp. 2. Clinical Research Institute, Cancer Biostatistics Laboratory, National Kyushu Cancer Center, Fukuoka, Japan. 3. Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 4. Department of Gastroenterological Surgery, Hirosaki University Graduate School of Medicine, Aomori, Japan. 5. Department of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu, Japan. 6. Department of Surgical Oncology, Osaka City University Graduate School of Medicine, Osaka, Japan. 7. Department of Surgery, Gastrointestinal Center, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan. 8. Department of Surgery, Fukui-ken Saiseikai Hospital, Fukui, Japan.
Abstract
BACKGROUND: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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
RCT Entities:
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
Authors: Gabriele Anania; Richard Justin Davies; Alberto Arezzo; Francesco Bagolini; Vito D'Andrea; Luigina Graziosi; Salomone Di Saverio; Georgi Popivanov; Isaac Cheruiyot; Roberto Cirocchi; Annibale Donini Journal: Int J Colorectal Dis Date: 2021-06-14 Impact factor: 2.571