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Title: 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.
Austin Authors: Schmoll, Hans-Joachim;Stein, Alexander;Van Cutsem, Eric;Price, Timothy;Hofheinz, Ralf D;Nordlinger, Bernard;Daisne, Jean-François;Janssens, Jos;Brenner, Baruch;Reinel, Hans;Hollerbach, Stephan;Caca, Karel;Fauth, Florian;Hannig, Carla V;Zalcberg, John;Tebbutt, Niall C ;Mauer, Murielle E;Marreaud, Sandrine;Lutz, Manfred P;Haustermans, Karin
Affiliation: Martin Luther University, Halle, Germany
University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Austin Health
Queen Elizabeth Hospital, Woodville, South Australia, Australia
Alfred Health and School of Public Health, Monash University, Melbourne, Victoria, Australia
Institute of Oncology, Davidoff Center, Rabin Medical Center, Petah Tikva, Israel
Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
University Hospitals and KU Leuven, Leuven, Belgium
Universitaetsmedizin Mannheim, Mannheim, Germany
CHU Ambroise Paré, Assistance Publique-Hôpitaux de Paris, Boulogne-Billancourt, France
Université Catholique de Louvain, CHU-UCL-Namur (Sainte-Elisabeth), Namur, Belgium
AZ Turnhout, Turnhout, Belgium
Leopoldina-Krankenhaus der Stadt Schweinfurt gGmbH, Schweinfurt, Germany
Allgemeines Krankenhaus Celle, Celle, Germany
Klinikum Ludwigsburg, Ludwigsburg, Germany
Onkologische Schwerpunktpraxis, Hanau, Germany
Gemeinschaftspraxis Haematologie und Onkologie, Bottrop, Germany
European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium
Caritasklinikum, Saarbrucken, Germany
University Hospitals and KU Leuven, Leuven, Belgium
Issue Date: 1-Jan-2021 2020-10-01
Publication information: Journal of Clinical Oncology 2021; 39(1): 17-29
Abstract: The PETACC 6 trial investigates whether the addition of oxaliplatin to preoperative capecitabine-based chemoradiation and postoperative capecitabine improves disease-free survival (DFS) in locally advanced rectal cancer. Between November 2008 and September 2011, patients with rectal adenocarcinoma within 12 cm from the anal verge, T3/4 and/or node positive, were randomly assigned 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. The primary end point was improvement of 3-year DFS by oxaliplatin from 65% to 72% (hazard ratio [HR], 0.763). A total of 1,094 patients were randomly assigned (intention to treat), and 1,068 eligible patients started their allocated treatment (arm 1, 543; arm 2, 525), with completion of protocol treatment in 68% (arm 1) v 54% (arm 2). A higher rate of grade 3/4 adverse events was reported in the experimental arm (14.4% v 37.3% and 23.4% v 46.6% for neoadjuvant and adjuvant treatment, respectively). At a median follow-up of 68 months (interquartile range, 58-74 months), 157 and 156 DFS events were observed in arms 1 and 2, respectively (adjusted HR, 1.02; 95% CI, 0.82 to 1.28; P = .835). Three-year DFS rate was not different, with 76.5% (95% CI, 72.7% to 79.9%) in arm 1, which is higher than anticipated, and 75.8% (95% CI, 71.9% to 79.3%) in arm 2. The 7-year DFS and overall survival (OS) rates were not different as well, with DFS of 66.1% v 65.5% (HR, 1.02) and OS of 73.5% v 73.7% (HR, 1.19) in arms 1 and 2, respectively. Subgroup analyses revealed heterogeneity in treatment effect according to German versus non-German site location, without detectable confounding factors in multivariable analysis. The addition of oxaliplatin to preoperative capecitabine-based chemoradiation and postoperative adjuvant chemotherapy impairs tolerability and feasibility and does not improve efficacy.
DOI: 10.1200/JCO.20.01740
ORCID: 0000-0001-8705-0593
PubMed URL: 33001764
Type: Journal Article
Appears in Collections:Journal articles

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