Short-term outcomes of chemoradiotherapy and local excision vs total mesorectal excision in T2–T3ab,N0,M0 rectal cancer. A multicentre randomised, controlled, phase III trial (the TAUTEM study)
Mené en Espagne sur 173 patients atteints d'un adénocarcinome rectal de stade T2-T3ab-N0-M0, cet essai randomisé multicentrique de phase III évalue la non-infériorité, du point de vue du taux de morbidité et du taux de réponse complète, d'un traitement combinant chimioradiothérapie préopératoire et microchirurgie endoscopique transanale par rapport à une exérèse mésorectale totale
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 preoperative 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: 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). Postoperative morbidity was 17/82 (20.7%) in the CRT-TEM group and 41/81 (50.6%) in the TME group (p<0.001, 95 CI% 43.9 to 15.9). 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%). Postoperative complications and hospitalisation rates were significantly lower than in the TME group. We await the results of the follow-up regarding cancer outcomes and quality of life.
Annals of Oncology 2022