This month's paper assessed the noninferior results of chemoradiotherapy and local excision compared with Total Mesorectal Excision in T2-T3ab, N0, M0 Rectal Cancer.
Chemoradiotherapy and Local Excision vs Total Mesorectal Excision in T2-T3ab, N0, M0 Rectal Cancer: The TAUTEM Randomized Clinical Trial
Xavier Serra-Aracil, Carles Pericay, Ariadna Cidoncha, Jesus Badia-Closa, Thomas Golda, Esther Kreisler, Pilar Hernández, Eduardo Targarona, Nerea Borda-Arrizabalaga, Angel Reina, Salvadora Delgado, Eloy Espín-Bassany, Aleidis Caro-Tarrago, Javier Gallego-Plazas, Marta Pascual, Carlos Álvarez-Laso, Hector Guadalajara-Labajo, Ana Otero, Sebastiano Biondo; TAUTEM Collaborative Group. JAMA Surg. 2025 Jul 1;160(7):783-793. doi: 10.1001/jamasurg.2025.1398.
What is known about the subject?
By improving the multimodal approach in the treatment of rectal cancer, it has been possible to move towards less destructive surgical strategies: from abdominoperineal resection to organ-preserving surgery.
The local excision (LE) procedure has now been widely codified for now in early rectal cancer (cT1), with good clinical outcomes. In contrast, total mesorectal excision (TME) for cT2 low rectal cancer or cT3-4 after chemoradiotherapy (CRT) is still associated with high rates of postoperative morbidity and impact on quality of life. In an organ-preserving setting, LE could be considered a conservative approach to minimising the risk of complications from major surgery, which was previously the standard procedure following neoadjuvant chemoradiotherapy. According to current guidelines, LE is a safe approach to cT1N0M0 rectal cancer. In a 2020 meta-analysis, Peltrini et al. (https://doi.org/10.1007/s13304-019-00689-2) concluded that local excision following neoadjuvant chemoradiotherapy could be considered for patients with significant comorbidities (who are therefore at high risk of complications from radical surgery) or who refuse abdominoperineal resection. Nevertheless, total mesorectal excision (TME) remains the gold standard treatment following neoadjuvant chemoradiotherapy. Furthermore, TME is the widely accepted standard treatment for stage T2–T3aN0M0 rectal cancer.
What does this study add?
The TAUTEM study is a multicentre, prospective, open-label, noninferiority, phase 3 randomised clinical trial comparing total mesorectal excision (TME group) with chemoradiotherapy followed by local excision using transanal endoscopic microsurgery (CRT-TEM group) in terms of local recurrence.
A total of 173 patients with T2-T3ab N0, M0 rectal adenocarcinoma within 10 cm from the anal verge with no metastasis were recruited.
In the 5-year modified intention-to-treat analysis:
- LR was 6.2% in the TME group and 7.4% in the CRT-TEM group (difference, -1.23%; 95% CI, 6.51% to -8.98%).
- DR was 17.3% in the TME group and 12.3% in the CRT-TEM group (difference, 4.94%; 95% CI, 15.85% to -5.98%).
- OS was 85.2% in the TME group and 82.7% in the CRT-TEM group (difference, 2.47%; 95% CI, 0.38%-1.78%).
- DFS in both groups was 88.9% (72 of 81), with a 95% CI of 9.68 to -9.68.
Implications for colorectal practice
In terms of local recurrence, CRT-TEM achieved non-inferior results compared to standard TME, with similar results observed for disease recurrence, overall survival, and diseases free survival.
Based on these results, CRT-TEM appears to be a suitable treatment option for patients with T2-T3ab, N0, M0 rectal cancer.