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000292460 1001_ $$0P:(DE-HGF)0$$aFokas, Emmanouil$$b0
000292460 245__ $$aChemoradiotherapy plus induction or consolidation chemotherapy as total neoadjuvant therapy for locally advanced rectal cancer: Pooled analysis of the CAO/ARO/AIO-12 and the OPRA randomized phase 2 trials.
000292460 260__ $$aAmsterdam [u.a.]$$bElsevier$$c2024
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000292460 520__ $$aTotal neoadjuvant therapy (TNT) has been used for patients with locally advanced rectal cancer. The optimal sequence of chemoradiotherapy (CRT) and chemotherapy (CT) is a matter of debate.We performed a pooled analysis of the CAO/ARO/AIO-12 and OPRA multicenter, randomized phase 2 trials to identify patient subsets that could benefit from one TNT sequence over the other regarding disease-free survival (DFS). Patients with stage II/III rectal cancer were randomized to CRT (50.4-54 Gy) with either induction (INCT-CRT) or consolidation CT (CRT-CNCT) with fluorouracil, leucovorin, oxaliplatin (CAO/ARO/AIO-12 and OPRA) or capecitabine and oxaliplatin (OPRA) followed by mandatory total mesorectal excision (TME) (CAO/ARO/AIO-12) or selective watch-and-wait surveillance (OPRA). 311 and 324 patients were recruited from June 15, 2015 to January 31, 2018; and from April 12, 2014 to March 30, 2020 in the two trials, respectively. Pretreatment clinical and tumor characteristics included were age, sex, ECOG, cT-category, cN-category, clinical UICC stage, location from anal verge, and tumor grade.In total, 628 eligible patients were included in the pooled analysis (CAO/ARO/AIO-12, n = 304; OPRA, n = 324). Of those, 313 were randomly assigned to the INCT-CRT group, and 315 to the CRT-CNCT group. Median follow-up was 43 months (IQR, 35-49) months in the CAO/ARO/AIO-12 trial and 61,2 months (IQR, 42-68,4) in the OPRA trial. Pooled analysis of baseline clinical and tumor characteristics did not identify any subgroups of patients that would benefit by the one TNT sequence over the other with regard to DFS.To our knowledge, this is the first pooled analysis of two randomized trials after direct head-to-head comparison of both TNT sequences. Both trials reported higher rates of complete response with CRT-CNCT, and this should be considered the preferred TNT sequence if organ preservation is a priority.
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000292460 650_7 $$2Other$$aOncological guidelines
000292460 650_7 $$2Other$$aPooled analysis
000292460 650_7 $$2Other$$aRandomized trials
000292460 650_7 $$2Other$$aRectal cancer
000292460 650_7 $$2Other$$aSequence
000292460 650_7 $$2Other$$aTotal neoadjuvant treatment
000292460 7001_ $$aWilliams, Hannah$$b1
000292460 7001_ $$0P:(DE-HGF)0$$aDiefenhardt, Markus$$b2
000292460 7001_ $$aLin, Sabrina$$b3
000292460 7001_ $$aQin, Li-Xuan$$b4
000292460 7001_ $$aPiso, Pompiliu$$b5
000292460 7001_ $$aDapper, Hendrik$$b6
000292460 7001_ $$aGermer, Christoph-Thomas$$b7
000292460 7001_ $$aGrützmann, Robert$$b8
000292460 7001_ $$aTim Friede, J.$$b9
000292460 7001_ $$aJoshua Smith, J.$$b10
000292460 7001_ $$aSaltz, Leonard B$$b11
000292460 7001_ $$aWu, Abraham J$$b12
000292460 7001_ $$aWeiser, Martin R$$b13
000292460 7001_ $$aOmer, Dana$$b14
000292460 7001_ $$aGhadimi, Michael$$b15
000292460 7001_ $$aHofheinz, Ralf-Dieter$$b16
000292460 7001_ $$aGarcia-Aguilar, Julio$$b17
000292460 7001_ $$0P:(DE-HGF)0$$aRödel, Claus$$b18
000292460 7001_ $$aGroup, German Rectal Cancer Study$$b19
000292460 7001_ $$aConsortium, the OPRA$$b20$$eCollaboration Author
000292460 773__ $$0PERI:(DE-600)1468190-0$$a10.1016/j.ejca.2024.114291$$gVol. 210, p. 114291 -$$p114291$$tEuropean journal of cancer$$v210$$x0014-2964$$y2024
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