Multicenter phase 3 trial of total neoadjuvant therapy with mFOLFIRINOX for locally advanced rectal cancer: long-term results of UNICANCER-PRODIGE 23

Treatment of locally advanced rectal cancer (LARC) with preoperative chemoradiotherapy (CRT) followed by surgery and adjuvant chemotherapy controls local disease, but distant metastases remain common. The phase 3 UNICANCER-PRODIGE 23 trial, at 35 centers in France, evaluated addition of mFOLFIRINOX before CRT for LARC (cT3 or cT4 M0). Long-term results of the trial have now been published. With a median follow-up of 82.2 months, the 7-year disease-free survival rate was 67.6% in the neoadjuvant chemotherapy group versus 62.5% in the standard therapy group (p=0.048), while the 7-year metastasis-free survival rate was 79.2% versus 72.3% (p=0.021) and the 7-year overall survival rate was 81.9% versus 76.1% (p=0.033). There were no new safety signals. The authors conclude that neoadjuvant chemotherapy with mFOLFIRINOX before preoperative CRT followed by surgery and adjuvant chemotherapy improved disease-free survival, metastasis-free survival, and overall survival.