Results of a prospective single-center randomized study on the role of neoadjuvant chemotherapy in the combined treatment of patients with stage III colon cancer (Node-Rads scores 3-5)

Background: The optimal treatment strategy for patients with stage III colon cancer remains a subject of active research. While adjuvant chemotherapy (ACT) following surgery is the current standard, the potential role of neoadjuvant chemotherapy (NeoACT) in improving treatment outcomes is increasingly being investigated. Objective: To evaluate the impact of neoadjuvant chemotherapy (NeoACT) on surgical outcomes in patients with stage III colon cancer (Node-RADS scores 3-5). Materials and methods: A prospective, single-center, randomized clinical trial included 108 patients divided into two groups: NeoACT (n = 54) and primary surgery (n = 54). Patients in the NeoACT group received chemotherapy using either the CapOX regimen (4 cycles) or FOLFOX6 (6 cycles), followed by surgery. Surgical outcomes (operation duration, intraoperative blood loss, conversion rate, postoperative complications according to Clavien-Dindo, and length ofhospital stay) and pathological findings were analyzed. Results: NeoACT did not adversely affect surgical outcomes. The median operation time was 180 minutes, and the median hospital stay was 8.7 days. Intraoperative blood loss was 50-100 ml in both groups. A statistically sig¬nificant increase in conversion from laparoscopy to laparotomy was observed in the NeoACT group (p = 0.046). The rates of Clavien-Dindo grade 3a — b complications were 4.2 % and 3.8 %, respectively (p = 1). NeoACT resulted in a higher rate of pNO (p < 0.001), reduced incidence of pT4b (p = 0.053) and pN2 (p = 0.06), and lower presence of lymphovascular invasion (p < 0.001). Only 59.3 % of patients in the NeoACT group required 3 months of ACT, compared to 71.2 % of patients in the primary surgery group who received 6 months (p < 0.001). Conclusion: NeoACT does not increase the rate of postoperative complications and contributes to tumor down¬staging, leading to reduced need for adjuvant chemotherapy. The inclusion of patients with Node-RADS scores 4-5 minimized the risk of overtreatment from 25% to 8%.