早期直肠癌局部切除术后根治性手术与辅助放化疗的多中心随机试验。
A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer.
作者信息
Borstlap W A A, Tanis P J, Koedam T W A, Marijnen C A M, Cunningham C, Dekker E, van Leerdam M E, Meijer G, van Grieken N, Nagtegaal I D, Punt C J A, Dijkgraaf M G W, De Wilt J H, Beets G, de Graaf E J, van Geloven A A W, Gerhards M F, van Westreenen H L, van de Ven A W H, van Duijvendijk P, de Hingh I H J T, Leijtens J W A, Sietses C, Spillenaar-Bilgen E J, Vuylsteke R J C L M, Hoff C, Burger J W A, van Grevenstein W M U, Pronk A, Bosker R J I, Prins H, Smits A B, Bruin S, Zimmerman D D, Stassen L P S, Dunker M S, Westerterp M, Coene P P, Stoot J, Bemelman W A, Tuynman J B
机构信息
Department of Surgery, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Department of Surgery, VU University Medical Center, De Boelelaan 1117, 1081 HZ, Amsterdam, The Netherlands.
出版信息
BMC Cancer. 2016 Jul 21;16:513. doi: 10.1186/s12885-016-2557-x.
BACKGROUND
Rectal cancer surgery is accompanied with high morbidity and poor long term functional outcome. Screening programs have shown a shift towards more early staged cancers. Patients with early rectal cancer can potentially benefit significantly from rectal preserving therapy. For the earliest stage cancers, local excision is sufficient when the risk of lymph node disease and subsequent recurrence is below 5 %. However, the majority of early cancers are associated with an intermediate risk of lymph node involvement (5-20 %) suggesting that local excision alone is not sufficient, while completion radical surgery, which is currently standard of care, could be a substantial overtreatment for this group of patients.
METHODS/STUDY DESIGN: In this multicentre randomised trial, patients with an intermediate risk T1-2 rectal cancer, that has been locally excised using an endoluminal technique, will be randomized between adjuvant chemo-radiotherapylimited to the mesorectum and standard completion total mesorectal excision (TME). To strictly monitor the risk of locoregional recurrence in the experimental arm and enable early salvage surgery, there will be additional follow up with frequent MRI and endoscopy. The primary outcome of the study is three-year local recurrence rate. Secondary outcomes are morbidity, disease free and overall survival, stoma rate, functional outcomes, health related quality of life and costs. The design is a non inferiority study with a total sample size of 302 patients.
DISCUSSION
The results of the TESAR trial will potentially demonstrate that adjuvant chemoradiotherapy is an oncological safe treatment option in patients who are confronted with the difficult clinical dilemma of a radically removed intermediate risk early rectal cancer by polypectomy or transanal surgery that is conventionally treated with subsequent radical surgery. Preserving the rectum using adjuvant radiotherapy is expected to significantly improve morbidity, function and quality of life if compared to completion TME surgery.
TRIAL REGISTRATION
NCT02371304 , registration date: February 2015.
背景
直肠癌手术伴随着高发病率和较差的长期功能预后。筛查项目显示癌症分期有向更早阶段转变的趋势。早期直肠癌患者可能从保留直肠的治疗中显著获益。对于最早阶段的癌症，当淋巴结转移和后续复发风险低于5%时，局部切除就足够了。然而，大多数早期癌症伴有淋巴结受累的中度风险（5%-20%），这表明仅局部切除是不够的，而目前作为标准治疗的根治性手术对这组患者可能是过度治疗。
方法/研究设计：在这项多中心随机试验中，采用腔内技术进行局部切除的中度风险T1-2期直肠癌患者，将被随机分为仅对直肠系膜进行辅助放化疗和标准的根治性全直肠系膜切除术（TME）两组。为了严格监测试验组局部区域复发的风险并能进行早期挽救性手术，将通过频繁的MRI和内镜检查进行额外随访。该研究的主要结局是三年局部复发率。次要结局包括发病率、无病生存期和总生存期、造口率、功能结局、健康相关生活质量和成本。该设计是一项非劣效性研究，总样本量为302例患者。
讨论
TESAR试验的结果可能会证明，对于通过息肉切除术或经肛门手术局部切除的中度风险早期直肠癌患者，传统上后续需进行根治性手术，而辅助放化疗是一种肿瘤学上安全的治疗选择。与根治性TME手术相比，使用辅助放疗保留直肠有望显著改善发病率、功能和生活质量。
试验注册
NCT02371304，注册日期：2015年2月。
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