Background/Aim: Neoadjuvant chemoradiation (nCRT) in rectal cancer is associated with significant long-term morbidity. It is unclear whether nCRT in resectable mesorectal fascia circumferential resection margin (mrCRM)-negative rectal cancer treated by adequate total mesorectal excision (TME) is beneficial. The aim was to determine if nCRT can be omitted in patients with MRI-assessed cT3 rectal cancer and a negative mrCRM undergoing good-quality TME. Methods: By means of a prospective nationwide registry (n = 43.147; prospective multi-center observational study), patients with cT3 rectal cancer #x3c;12 cm from the anal verge with a negative (#x3e;1 mm) MRI-assessed CRM undergoing radical resection from 2006 to 2008 were selected. Overall, 87 patients were available for the final analysis (TME-alone, n = 25; nCRT+TME, n = 62). Groups were balanced for age, sex, and ASA score, with a nonsignificant predominance of males in the nCRT+TME group. As main outcome measures, local and distant recurrence rates were compared between patients undergoing primary surgery (TME-alone) vs. neoadjuvant chemoradiation + surgery (nCRT+TME). Results: In the TME-alone group, tumors were located closer to the anal verge (p = 0.018) and demonstrated a smaller minimal circumferential distance from the resection margin (p = 0.036). TME quality was comparable, as was median follow-up (48.9 vs. 44.9 months; p = 0.268). Local recurrences occurred at a similar rate in the TME-alone (n = 1; 5.3%) and nCRT+TME groups (n = 3; 5.5%) (p = 0.994) and were diagnosed at 10 months (TME-alone) and at 8, 13, and 18 months (nCRT+TME). Distant recurrences occurred in 28.9 and 17.4% of the cases, respectively (p = 0.626). The analysis was limited to cT3 cancers with a negative mrCRM. In addition, caution is required when appraising these results because of the limited number of evaluable subjects (especially in the TME-alone group), which adds some uncertainty to the statistical analysis. Conclusions: In this cohort of patients with rectal cancer located #x3c;12 cm from the anal verge and a negative mrCRM undergoing adequate TME, omission of nCRT had no impact onto the local recurrence rate.
Visc Med

中文翻译：

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前瞻性多中心观察研究中 cT3 直肠癌的多模式治疗：在 MRI 评估的周缘切除边缘阴性的患者中是否可以省略新辅助放化疗？

背景/目的：直肠癌的新辅助放化疗 (nCRT) 与显着的长期发病率相关。目前尚不清楚通过充分的全直肠系膜切除术 (TME) 治疗可切除直肠系膜筋膜周缘切缘 (mrCRM) 阴性直肠癌的 nCRT 是否有益。目的是确定在 MRI 评估的 cT3 直肠癌和接受优质 TME 的 mrCRM 阴性的患者中是否可以省略 nCRT。方法：通过前瞻性的全国登记（ n= 43.147; 前瞻性多中心观察研究），选择了 2006 年至 2008 年接受根治性切除术的 cT3 直肠癌患者，距肛缘 12 cm，MRI 评估为阴性（#x3e;1 mm）。总体而言，87 名患者可用于最终分析（仅 TME，n = 25；nCRT+TME，n = 62）。各组在年龄、性别和 ASA 评分方面保持平衡，在 nCRT+TME 组中男性的优势不显着。作为主要结局指标，比较接受初次手术（仅 TME）与新辅助放化疗+手术（nCRT+TME）的患者的局部和远处复发率。结果：在 TME 单独组中，肿瘤位于更靠近肛缘的位置（p= 0.018），并证明距切除边缘的最小圆周距离更小（p = 0.036）。TME 质量具有可比性，中位随访时间也是如此（48.9 个月对 44.9 个月；p = 0.268）。仅 TME（ n = 1；5.3%）和 nCRT+TME 组（n = 3；5.5%）（p = 0.994）的局部复发率相似，并在 10 个月时被诊断（仅 TME）和在 8、13 和 18 个月时 (nCRT+TME)。远处复发率分别为 28.9% 和 17.4%（p= 0.626）。该分析仅限于 mrCRM 阴性的 cT3 癌症。此外，在评估这些结果时需要谨慎，因为可评估的受试者数量有限（特别是在 TME 单独组中），这给统计分析增加了一些不确定性。结论：在这组直肠癌患者队列中，位于#x3c；距肛缘 12 cm 且 mrCRM 阴性且接受足够 TME 的患者中，省略 nCRT 对局部复发率没有影响。
粘性医学