Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
Dis Esophagus. 2020 Nov 26;33(Supplement_2). doi: 10.1093/dote/doaa079.
Initial results of the ROBOT, which randomized between robot-assisted minimally invasive esophagectomy (RAMIE) and open transthoracic esophagectomy (OTE), showed significantly better short-term postoperative outcomes in favor of RAMIE. However, it is not yet clarified if RAMIE is equivalent to OTE regarding long-term outcomes. The aim of this study was to report the long-term oncological results of the ROBOT trial in terms of survival and disease-free survival. This study is a follow-up study of the ROBOT trial, which was a randomized controlled trial comparing RAMIE to OTE in 112 patients with intrathoracic esophageal cancer. Both the trial protocol and short-term results were previously published. The primary outcome of the current study was 5-year overall survival. Secondary outcomes were disease-free survival and recurrence patterns. Analysis was by intention to treat. During the recruitment period, 109 patients were included in the survival analysis (RAMIE n = 54, OTE n = 55). Majority of patients had clinical stage III or IV (RAMIE 63%, OTE 55%) and received neoadjuvant chemoradiotherapy (80%). Median follow-up was 60 months (range 31-60). The combined 5-year overall survival rates for RAMIE and OTE were 41% (95% CI 27-55) and 40% (95% CI 26-53), respectively (log rank test P = 0.827). The 5-year disease-free survival rate was 42% (95% CI 28-55) in the RAMIE group and 43% (95% CI 29-57) in the OTE group (log rank test P = 0.749). Out of 104 patients, 57 (55%) developed recurrent disease detected at a median of 10 months (range 0-56) after surgery. No statistically difference in recurrence rate nor recurrence pattern was observed between both groups. Overall survival and disease-free survival of RAMIE are comparable to OTE. These results continue to support the use of robotic surgery for esophageal cancer.
机器人手术治疗食管肿瘤的随机对照研究（ROBOT）的初步结果显示，机器人辅助微创食管切除术（RAMIE）与开胸食管切除术（OTE）相比，具有明显更好的短期术后转归。然而，RAMIE 在长期结果方面是否与 OTE 相当尚不清楚。本研究旨在报告 ROBOT 试验的长期肿瘤学结果，包括生存和无病生存。本研究是 ROBOT 试验的随访研究，该试验是一项随机对照试验，比较了 112 例胸内食管癌患者的 RAMIE 与 OTE。试验方案和短期结果均已发表。本研究的主要结局是 5 年总生存率。次要结局是无病生存率和复发模式。分析采用意向治疗。在招募期间，有 109 例患者纳入生存分析（RAMIE 组 n=54，OTE 组 n=55）。大多数患者为临床分期 III 期或 IV 期（RAMIE 组 63%，OTE 组 55%），并接受新辅助放化疗（80%）。中位随访时间为 60 个月（范围 31-60 个月）。RAMIE 和 OTE 的 5 年总生存率分别为 41%（95%CI 27-55）和 40%（95%CI 26-53）（对数秩检验 P=0.827）。RAMIE 组的 5 年无病生存率为 42%（95%CI 28-55），OTE 组为 43%（95%CI 29-57）（对数秩检验 P=0.749）。在 104 例患者中，57 例（55%）在术后中位时间 10 个月（范围 0-56 个月）时检测到复发疾病。两组之间复发率和复发模式无统计学差异。RAMIE 的总生存率和无病生存率与 OTE 相当。这些结果继续支持机器人手术治疗食管癌。
