Abstract：
The standard approach for locally advanced rectal cancer (LARC) is neoadjuvant chemoradiotherapy (nCRT) followed by total mesorectal excision (TME). After nCRT 20% of patients achieve a clinical complete response (pCR) and could be treated with a non-operative management (NOM).
The panel of the Italian Association of Medical Oncology (AIOM) Guidelines on rectal cancer applied the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach addressing the following question: Should NOM vs. TME be used for patients with rectal cancer with clinical complete response after nCRT? Five outcomes were identified: disease-free survival (DFS), mortality, local recurrence, colostomy rate, and functional outcomes.
Nine studies were included in the analysis. A higher risk of disease recurrence was observed in the NOM group compared to the TME group (RR = 1.69, 95% CI 1.08, 2.64) on the other hand, we observed a slightly positive but not significant effect on mortality of NOM (RR = 0.82, 95% CI 0.46, 1.45). Patients in the NOM group were more likely to experience local recurrence (RR = 5.37, 95% CI 2.56, 11.27) and patients in the TME group were more likely to have a permanent colostomy (RR = 0.15, 95% CI 0.08, 0.29). Only one study evaluated functional outcomes. The overall certainty of evidence was rated as very low.
NOM was found to correlate with a higher risk of local recurrence which did not translate in worse OS and a lower colostomy rate. Due to the paucity of evidences, no recommendations are possible. NOM remains an experimental treatment; thus, patients managed with NOM should be enrolled in clinical trials with a dedicated follow-up schedule.
The panel of the Italian Association of Medical Oncology (AIOM) Guidelines on rectal cancer applied the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach addressing the following question: Should NOM vs. TME be used for patients with rectal cancer with clinical complete response after nCRT? Five outcomes were identified: disease-free survival (DFS), mortality, local recurrence, colostomy rate, and functional outcomes.
Nine studies were included in the analysis. A higher risk of disease recurrence was observed in the NOM group compared to the TME group (RR = 1.69, 95% CI 1.08, 2.64) on the other hand, we observed a slightly positive but not significant effect on mortality of NOM (RR = 0.82, 95% CI 0.46, 1.45). Patients in the NOM group were more likely to experience local recurrence (RR = 5.37, 95% CI 2.56, 11.27) and patients in the TME group were more likely to have a permanent colostomy (RR = 0.15, 95% CI 0.08, 0.29). Only one study evaluated functional outcomes. The overall certainty of evidence was rated as very low.
NOM was found to correlate with a higher risk of local recurrence which did not translate in worse OS and a lower colostomy rate. Due to the paucity of evidences, no recommendations are possible. NOM remains an experimental treatment; thus, patients managed with NOM should be enrolled in clinical trials with a dedicated follow-up schedule.
摘要：
局部晚期直肠癌（LARC）的标准方法是新辅助放化疗（nCRT），然后是全直肠系膜切除术（TME）。nCRT后，20％的患者达到临床完全缓解（pCR），可以通过非手术管理（NOM）进行治疗。
意大利医学肿瘤协会（AIOM）直肠癌指南的小组采用了建议的分级，评估,开发和评估(等级)方法解决以下问题：NOM与TME可用于在nCRT后有临床完全缓解的直肠癌患者？确定了五个结果：无病生存（DFS），死亡率,局部复发,结肠造口术率,和功能结果。
九项研究包括在分析中。另一方面，与TME组相比，NOM组的疾病复发风险更高（RR=1.69，95％CI1.08，2.64），我们观察到对NOM的死亡率有轻微的正效应,但不显著(RR=0.82,95%CI0.46,1.45).NOM组患者更有可能出现局部复发（RR=5.37，95%CI2.56，11.27），TME组患者更有可能进行永久性结肠造口术（RR=0.15，95%CI0.08，0.29）。只有一项研究评估了功能结果。证据的总体确定性被评为非常低。
发现NOM与较高的局部复发风险相关，但未转化为较差的OS和较低的结肠造口术率。由于缺乏证据,没有建议是可能的。NOM仍然是一种实验性治疗；因此，接受NOM治疗的患者应纳入有专门随访时间表的临床试验.
意大利医学肿瘤协会（AIOM）直肠癌指南的小组采用了建议的分级，评估,开发和评估(等级)方法解决以下问题：NOM与TME可用于在nCRT后有临床完全缓解的直肠癌患者？确定了五个结果：无病生存（DFS），死亡率,局部复发,结肠造口术率,和功能结果。
九项研究包括在分析中。另一方面，与TME组相比，NOM组的疾病复发风险更高（RR=1.69，95％CI1.08，2.64），我们观察到对NOM的死亡率有轻微的正效应,但不显著(RR=0.82,95%CI0.46,1.45).NOM组患者更有可能出现局部复发（RR=5.37，95%CI2.56，11.27），TME组患者更有可能进行永久性结肠造口术（RR=0.15，95%CI0.08，0.29）。只有一项研究评估了功能结果。证据的总体确定性被评为非常低。
发现NOM与较高的局部复发风险相关，但未转化为较差的OS和较低的结肠造口术率。由于缺乏证据,没有建议是可能的。NOM仍然是一种实验性治疗；因此，接受NOM治疗的患者应纳入有专门随访时间表的临床试验.
