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Pre- and postoperative capecitabine without or with oxaliplatin in locally advanced rectal cancer: PETACC 6 trial by EORTC GITCG and ROG, AIO, AGITG, BGDO, and FFCD

Journal of Clinical Oncology Oct 08, 2020

Schmoll HJ, Stein A, Van Cutsem E, et al. - Whether improved disease-free survival (DFS) can be achieved in locally advanced rectal cancer by adding oxaliplatin to preoperative capecitabine-based chemoradiation and postoperative capecitabine was determined in the PETACC 6 trial. Participants were patients with rectal adenocarcinoma within 12 cm from the anal verge, T3/4 and/or node positive. These patients were randomized to 5 weeks preoperative capecitabine-based chemoradiation (45-50.4 Gy) followed by six cycles of adjuvant capecitabine, both without (control arm, 1) or with (experimental arm, 2) oxaliplatin. Three-year DFS improvement with oxaliplatin from 65% to 72% was the primary endpoint. The experimental arm had a higher rate of grade 3/4 adverse events. Overall, tolerability and feasibility were impaired while no improvement in efficacy was observed in correlation with the addition of oxaliplatin to preoperative capecitabine-based chemoradiation and postoperative adjuvant chemotherapy.

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