Cover Image

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

PURPOSE 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. METHODS Between November 2008 and September 2011, patients with rectal...

Full description

Saved in:
Bibliographic Details
Main Authors: Schmoll, Hans-Joachim (Author) , Stein, Alexander (Author) , Van Cutsem, Eric (Author) , Price, Timothy (Author) , Hofheinz, Ralf-Dieter (Author) , Nordlinger, Bernard (Author) , Daisne, Jean-François (Author) , Janssens, Jos (Author) , Brenner, Baruch (Author) , Reinel, Hans (Author) , Hollerbach, Stephan (Author) , Caca, Karel (Author) , Fauth, Florian (Author) , Hannig, Carla V. (Author) , Zalcberg, John (Author) , Tebbutt, Niall (Author) , Mauer, Murielle E. (Author) , Marreaud, Sandrine (Author) , Lutz, Manfred Paul (Author) , Haustermans, Karin (Author)
Format: Article (Journal)
Language:English
Published: October 1, 2020
In: Journal of clinical oncology
Year: 2020, Volume: 39, Issue: 1, Pages: 17-29
ISSN:1527-7755
DOI:10.1200/JCO.20.01740
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1200/JCO.20.01740
Verlag, lizenzpflichtig, Volltext: https://ascopubs.org/doi/abs/10.1200/JCO.20.01740
Get full text
Author Notes:Hans-Joachim Schmoll, Alexander Stein, Eric Van Cutsem, Timothy Price, Ralf D. Hofheinz, Bernard Nordlinger, Jean-François Daisne, Jos Janssens, Baruch Brenner, Hans Reinel, Stephan Hollerbach, Karel Caca, Florian Fauth, Carla V. Hannig, John Zalcberg, Niall Tebbutt, Murielle E. Mauer, Sandrine Marreaud, Manfred P. Lutz and Karin Haustermans
Description
Summary:PURPOSE 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. METHODS 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).RESULTSA 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. CONCLUSION The addition of oxaliplatin to preoperative capecitabine-based chemoradiation and postoperative adjuvant chemotherapy impairs tolerability and feasibility and does not improve efficacy.
Item Description:Gesehen am 28.04.2021
Physical Description:Online Resource
ISSN:1527-7755
DOI:10.1200/JCO.20.01740

Similar Items