Department of Surgery, University of Otago, Christchurch, New Zealand.
Ann Surg. 2012 Dec;256(6):915-9. doi: 10.1097/SLA.0b013e3182765ff8.
: We report a multicentered randomized controlled trial across Australia and New Zealand comparing laparoscopic-assisted colon resection (LCR) with open colon resection (OCR) for colon cancer.
: Colon cancer is a significant worldwide health issue. This trial investigated whether the short-term benefits associated with LCR for colon cancer could be achieved safely, without survival disadvantages, in our region.
: A total of 601 patients with potentially curable colon cancer were randomized to receive LCR or OCR. Primary endpoints were 5-year overall survival, recurrence-free survival, and freedom from recurrence rates, compared using an intention-to-treat analysis.
: On April 5, 2010, 587 eligible patients were followed for a median of 5.2 years (range, 1 week-11.4 years) with 5-year confirmed follow-up data for survival and recurrence on 567 (96.6%). Significant differences between the 2 trial groups were as follows: LCR patients were older at randomization, and their pathology specimens showed smaller distal resection margins; OCR patients had some worse pathology parameters, but there were no differences in disease stages. There were no significant differences between the LCR and OCR groups in 5-year follow-up of overall survival (77.7% vs 76.0%, P = 0.64), recurrence-free survival (72.7% vs 71.2%, P = 0.70), or freedom from recurrence (86.2% vs 85.6%, P = 0.85).
: In spite of some differences in short-term surrogate oncological markers, LCR was not inferior to OCR in direct measures of survival and disease recurrence. These findings emphasize the importance of long-term data in formulating evidence-based practice guidelines.
我们报告了一项澳大利亚和新西兰多中心随机对照试验，比较腹腔镜辅助结肠切除术（LCR）与开腹结肠切除术（OCR）治疗结肠癌的效果。
结肠癌是一个全球性的重大健康问题。本试验旨在研究在我们的地区，LCR 治疗结肠癌的短期益处是否可以安全获得，而不会带来生存劣势。
共有 601 例潜在可治愈的结肠癌患者被随机分为 LCR 组或 OCR 组。主要终点是使用意向治疗分析比较 5 年总生存率、无复发生存率和无复发生存率。
2010 年 4 月 5 日，587 例符合条件的患者被随访，中位随访时间为 5.2 年（范围为 1 周至 11.4 年），567 例（96.6%）患者有 5 年的生存和复发确认随访数据。两组患者之间存在以下显著差异：LCR 组患者随机分组时年龄较大，其病理标本显示远端切除边缘较小；OCR 组患者的一些病理参数较差，但疾病分期无差异。LCR 组和 OCR 组患者在 5 年总生存率（77.7% vs. 76.0%，P = 0.64）、无复发生存率（72.7% vs. 71.2%，P = 0.70）或无复发率（86.2% vs. 85.6%，P = 0.85）方面无显著差异。
尽管在短期肿瘤标志物方面存在一些差异，但 LCR 在生存和疾病复发的直接测量上并不劣于 OCR。这些发现强调了长期数据在制定循证实践指南中的重要性。
