Multicenter phase 2 trial of organ preservation after total neoadjuvant therapy for locally advanced rectal cancer

The phase 2 CAO/ARO/AIO-16 trial, at four centers in Germany, evaluated total neoadjuvant therapy with upfront chemoradiotherapy followed by consolidation chemotherapy in patients with locally advanced rectal cancer, with the aim of organ preservation. The toxicity profile was acceptable, and 37% of patients attained a clinical complete response. The median TME-free survival was 6.1 months, and the 3-year TME-free survival rate was 21%. The authors conclude that total neoadjuvant therapy is the preferred approach for attempting organ preservation in patients with locally advanced rectal cancer.