Université Paris Descartes, Department of Hepatogastroenterology and GI Oncology, hôpital européen Georges-Pompidou, 75015 Paris, France.
Université Paris Descartes, Department of Hepatogastroenterology and GI Oncology, hôpital européen Georges-Pompidou, 75015 Paris, France.
Clin Res Hepatol Gastroenterol. 2016 Nov;40(5):546-552. doi: 10.1016/j.clinre.2016.03.004. Epub 2016 May 2.
More than half the patients with rectal cancer present with locally advanced rectal disease at diagnosis with a high risk of recurrence. Preoperative chemoradiotherapy and standardized radical surgery with total mesorectal excision have been established as the 'gold standard' for treating these patients. Pathological staging using the ypTNM classification system to decide on adjuvant chemotherapy (ACT) is widely used in clinical practice, but the delivery of ACT is still controversial, as many discrepancies persist in the conclusions of different trials, due to heterogeneity of the inclusion criteria between studies, lack of statistical power, and variations in preoperative and adjuvant regimens. In 2014, a meta-analysis of four randomized phase-III trials (EORTC 22921, I-CNR-RT, PROCTOR-SCRIPT, CHRONICLE) failed to demonstrate any statistical efficacy of fluorouracil (5FU)-based ACT. Three recent randomized trials aimed to compare 5FU with 5FU plus oxaliplatin-based chemotherapy. Two of them (ADORE, CAO/ARO/AIO-04) appeared to find a disease-free survival benefit for patients treated with the combination therapy. Thus, while awaiting new data, it can be said that, as of 2015, patients with yp stage I tumors or histological complete response derived no benefit from adjuvant therapy. On the other hand, the FOLFOX chemotherapy regimen should be proposed for yp stage III patients, and may be considered for yp stage II tumors in fit patients with high-risk factors. Nevertheless, well-designed and sufficiently powered clinical trials dedicated to adjuvant treatments for rectal cancer remain justified in future to achieve a high level of proof in keeping with evidence-based medical standards.
超过一半的直肠癌患者在诊断时存在局部晚期直肠疾病,复发风险高。术前放化疗和标准化根治性手术联合全直肠系膜切除术已被确立为治疗这些患者的“金标准”。使用 ypTNM 分类系统进行病理分期以决定辅助化疗(ACT)在临床实践中被广泛应用,但 ACT 的实施仍存在争议,因为不同试验的结论存在许多差异,这归因于研究纳入标准的异质性、缺乏统计学效力以及术前和辅助方案的变化。2014 年,四项随机 III 期试验(EORTC 22921、ICNR-RT、PROCTOR-SCRIPT、CHRONICLE)的荟萃分析未能证明氟尿嘧啶(5FU)为基础的 ACT 有任何统计学疗效。最近三项旨在比较 5FU 与 5FU 加奥沙利铂化疗的随机试验。其中两项(ADORE、CAO/ARO/AIO-04)似乎为接受联合治疗的患者带来了无病生存获益。因此,在等待新数据的同时,可以说,截至 2015 年,yp 期 I 肿瘤或组织学完全缓解的患者从辅助治疗中获益。另一方面,对于 yp 期 III 期患者应推荐 FOLFOX 化疗方案,对于具有高危因素的 yp 期 II 期肿瘤且身体状况良好的患者也可以考虑使用该方案。然而,未来仍有必要进行专门针对直肠癌辅助治疗的设计良好且充分有力的临床试验,以达到符合循证医学标准的高水平证据。
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