Neoadjuvant CAPOX versus chemoradiation for locally advanced rectal cancer with uninvolved mesorectal fascia: final results of CONVERT

The multicenter phase 3 CONVERT study in China aimed to assess noninferiority of neoadjuvant chemotherapy (nCT) with capecitabine plus oxaliplatin (CAPOX) versus neoadjuvant chemoradiotherapy (nCRT) in the treatment of locally advanced rectal cancer (LARC). Final results of the trial have now been reported. A total of 589 patients with LARC within 12 cm from the anal verge and uninvolved mesorectal fascia were randomized to receive 4 neoadjuvant cycles of CAPOX alone (nCT group; n=300) or CRT with concurrent capecitabine (nCRT group; n=289). The median follow-up was 48 months. Three-year locoregional recurrence-free survival (LRRFS; primary endpoint) rate was 97.4% in the nCRT group and 96.3% in the nCT group (HR 1.40; 95% CI 0.53-3.68). The nCT and nCRT groups had similar 3-year disease-free survival (89.2% versus 87.9%; HR 0.88; 95% CI 0.54-1.44) and 3-year overall survival (95% versus 94.1% (0.86; 0.42-1.76). The nCT group had a lower incidence of grade 2-4 long-term adverse events (16.0% versus 26.3%; p=0.002) and proctitis (33.6% versus 41.7%; p=0.049) compared with the nCRT group. The authors conclude that the noninferiority of nCT versus nCRT was not confirmed with a very low incidence of local recurrence in both groups, but that nCT offers comparable disease-free survival and overall survival while mitigating the burden of toxicity.