T2-T3ab、N0、M0期直肠癌放化疗联合局部切除与全直肠系膜切除的短期疗效比较：一项多中心随机对照III期试验（TAU-TEM研究）
Short-term outcomes of chemoradiotherapy and local excision versus total mesorectal excision in T2-T3ab,N0,M0 rectal cancer: a multicentre randomised, controlled, phase III trial (the TAU-TEM study).
作者信息
Serra-Aracil X, Pericay C, Badia-Closa J, Golda T, Biondo S, Hernández P, Targarona E, Borda-Arrizabalaga N, Reina A, Delgado S, Vallribera F, Caro A, Gallego-Plazas J, Pascual M, Álvarez-Laso C, Guadalajara-Labajo H G, Mora-Lopez L
机构信息
Coloproctology Unit, Parc Tauli University Hospital, Sabadell, Institut d'investigació i innovació Parc Tauli I3PT, Department of Surgery, Universitat Autònoma de Barcelona, Barcelona.
Medical Oncology Department, Parc Tauli University Hospital, Sabadell, Institut d'investigació i innovació Parc Tauli I3PT, Barcelona.
出版信息
Ann Oncol. 2023 Jan;34(1):78-90. doi: 10.1016/j.annonc.2022.09.160. Epub 2022 Oct 8.
BACKGROUND
The standard treatment of T2-T3ab,N0,M0 rectal cancers is total mesorectal excision (TME) due to the high recurrence rates recorded with local excision. Initial reports of the combination of pre-operative chemoradiotherapy (CRT) and transanal endoscopic microsurgery (TEM) have shown reductions in local recurrence. The TAU-TEM study aims to demonstrate the non-inferiority of local recurrence and the improvement in morbidity achieved with CRT-TEM compared with TME. Here we describe morbidity rates and pathological outcomes.
PATIENTS AND METHODS
This was a prospective, multicentre, randomised controlled non-inferiority trial including patients with rectal adenocarcinoma staged as T2-T3ab,N0,M0. Patients were randomised to the CRT-TEM or the TME group. Patients included, tolerance of CRT and its adverse effects, surgical complications (Clavien-Dindo and Comprehensive Complication Index classifications) and pathological results (complete response in the CRT-TEM group) were recorded in both groups. Patients attended follow-up controls for local and systemic relapse.
TRIAL REGISTRATION
NCT01308190.
RESULTS
From July 2010 to October 2021, 173 patients from 17 Spanish hospitals were included (CRT-TEM: 86, TME: 87). Eleven were excluded after randomisation (CRT-TEM: 5, TME: 6). Modified intention-to-treat analysis thus included 81 patients in each group. There was no mortality after CRT. In the CRT-TEM group, one patient abandoned CRT, 1/81 (1.2%). The CRT-related morbidity rate was 29.6% (24/81). Post-operative morbidity was 17/82 (20.7%) in the CRT-TEM group and 41/81 (50.6%) in the TME group (P < 0.001, 95% confidence interval 42.9% to 16.7%). One patient died in each group (1.2%). Of the 81 patients in the CRT-TEM group who received the allocated treatment, 67 (82.7%) underwent organ preservation. Pathological complete response in the CRT-TEM group was 44.3% (35/79). In the TME group, pN1 were found in 17/81 (21%).
CONCLUSION
CRT-TEM treatment obtains high pathological complete response rates (44.3%) and a high CRT compliance rate (98.8%). Post-operative complications and hospitalisation rates were significantly lower than those in the TME group. We await the results of the follow-up regarding cancer outcomes and quality of life.
背景
由于局部切除术后复发率较高，T2 - T3ab、N0、M0期直肠癌的标准治疗方法是全直肠系膜切除术（TME）。术前放化疗（CRT）与经肛门内镜显微手术（TEM）联合应用的初步报告显示局部复发率有所降低。TAU - TEM研究旨在证明与TME相比，CRT - TEM在局部复发方面的非劣效性以及发病率的改善情况。在此，我们描述发病率和病理结果。
患者与方法
这是一项前瞻性、多中心、随机对照非劣效性试验，纳入T2 - T3ab、N0、M0期直肠腺癌患者。患者被随机分为CRT - TEM组或TME组。记录两组患者的纳入情况、对CRT的耐受性及其不良反应、手术并发症（根据Clavien - Dindo和综合并发症指数分类）以及病理结果（CRT - TEM组的完全缓解情况）。患者接受局部和全身复发的随访检查。
试验注册
NCT01308190。
结果
2010年7月至2021年10月，来自17家西班牙医院的173例患者被纳入研究（CRT - TEM组：86例，TME组：87例）。随机分组后有11例被排除（CRT - TEM组：5例，TME组：6例）。因此，改良意向性分析每组纳入81例患者。CRT治疗后无死亡病例。在CRT - TEM组，1例患者放弃CRT治疗，占1/81（1.2%）。CRT相关发病率为29.6%（24/81）。CRT - TEM组术后发病率为17/82（20.7%），TME组为41/81（50.6%）（P < 0.001，95%置信区间为42.9%至16.7%）。每组各有1例患者死亡（1.2%）。在CRT - TEM组接受分配治疗的81例患者中，67例（82.7%）接受了器官保留。CRT - TEM组的病理完全缓解率为44.3%（35/79）。在TME组，17/81（21%）发现pN1。
结论
CRT - TEM治疗获得了较高的病理完全缓解率（44.3%）和较高的CRT依从率（98.8%）。术后并发症和住院率显著低于TME组。我们期待关于癌症结局和生活质量的随访结果。
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