Effectiveness of the total neo-adjuvant therapy in rectal cancer treatment. Results of the randomized trial

To ASSESS effectiveness of total neoadjuvant therapy (TNT) for patients with rectal carcinoma. Patients and methods: patients with histologically proven rectal carcinoma were randomly assigned in two groups: in the TNT group after the neoadjuvant CRT 50-54 Gy with capecitabine 3 consolidation courses of XELOX were done, in the CTR group - conventional neoadjuvant CRT 50-54 Gy with capecitabine. At the end of the treatment, effect was assessed by MRI using the mrTRG scale. For patients with a full clinical response, who have refused surgery, «watch 28) months, complete clinical response observed in 23% (14/60) of TNT patients and in 7% (5/71) of THL patients (p=0.008). The pCR rate was 20% (9/45) in the TNT group and 8% (5/66) in the CRT group (p=0.05). The frequency of development of toxic reactions of degree 3-4, the frequency and structure of intra- and postoperative complications, as well as the frequency of R0 resection of the group did not differ statistically significantly. The total rate of Grade 3–4 toxicity, rate of intra- and postoperative complications, R0-resections rate did not differ between two groups. CONCLUSION: preliminary results of a randomized study demonstrated the effectiveness and safety of total neo-adjuvant therapy in rectal cancer treatment.