Addition of neoadjuvant FOLFIRINOX to standard treatment for locally advanced rectal cancer

Treatment of locally advanced rectal cancer with chemoradiotherapy, surgery, and adjuvant chemotherapy controls local disease, but distant metastases remain common. The phase 3 UNICANCER-PRODIGE 23 study in 35 centers in France randomized LARC patients to 6 cycles of neoadjuvant FOLFIRINOX followed by preoperative chemoradiotherapy, surgery and 3 months of adjuvant chemotherapy (n=231), or standard-of-care with chemoradiotherapy, surgery, and 6 months of adjuvant chemotherapy (n=230). Three-year disease-free survival rates were 76% in the FOLFIRINOX group versus 69% in the standard-of-care group (HR 0.69; p=0.034). During the adjuvant chemotherapy, the FOLFIRINOX group had less neurotoxicity and lymphopenia than the standard-of-care group.