• J. Am. Coll. Surg. · Oct 2020

    Observational Study

    Avoidance of Overtreatment of Rectal Cancer by Selective Chemoradiotherapy: Results of the Optimized Surgery and MRI-Based Multimodal Therapy Trial.

    • Reinhard Ruppert, Rainer Kube, Joachim Strassburg, Andreas Lewin, Joerg Baral, Christoph A Maurer, Joerg Sauer, Theodor Junginger, Paul Hermanek, Susanne Merkel, and other members of the OCUM Group.
    • Department of General and Visceral Surgery, Endocrine Surgery, and Coloproctology, Municipal Hospital of Munich-Neuperlach, Germany.
    • J. Am. Coll. Surg. 2020 Oct 1; 231 (4): 413-425.e2.

    BackgroundNeoadjuvant chemoradiotherapy (nCRT) in patients with rectal cancer carries a high risk of adverse effects. The aim of this study was to examine the selective application of nCRT based on patient risk profile, as determined by MRI, to find the optimal range between undertreatment and overtreatment.Study DesignIn this prospective multicenter observational study, nCRT before total mesorectal excision (TME) was indicated in high-risk patients with involved or threatened mesorectal fascia (≤1 mm), or cT4 or cT3 carcinomas of the lower rectal third. All other patients received primary surgery.ResultsOf the 1,093 patients, 878 (80.3%) were treated according to the protocol, 526 patients (59.9%) underwent primary surgery, and 352 patients (40.1%) underwent nCRT followed by surgery. The 3-year locoregional recurrence (LR) rate was 3.1%. Of 604 patients with clinical stages II and III, 267 (44.2%) had primary surgery; 337 (55.8%) received nCRT followed by TME. The 3-year LR rate was 3.9%, without significant differences between groups. In patients with clinical stages II and III who underwent primary surgery, 27.3% were diagnosed with pathological stage I.ConclusionsThe results justify the restriction of nCRT to high-risk patients with rectal cancer classified by pretreatment MRI. Provided that a high-quality MRI diagnosis, TME surgery, and standardized examination of the resected specimen are performed, nCRT, with its adverse effects, costs, and treatment time can be avoided in more than 40% of patients with stage II or III rectal cancer with minimal risk of undertreatment. (clinicaltrials.gov NCT325649).Copyright © 2020 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

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