We have located links that may give you full text access.
Primary surgery followed by selective chemoradiotherapy versus preoperative chemoradiotherapy followed by surgery for locally advanced rectal cancer: A Randomized Clinical Trial.
PURPOSE: To determine whether LARC with negative mesorectal fascia (MRF) predicted by magnetic resonance imaging (MRI) can be excluded from preoperative radiotherapy treatment.
METHOD: This multicenter, open-label, non-inferiority, randomized clinical trial enrolled patients with LARC within 6-12 cm from the anal verge and with negative MRI-predicted MRF. Participants were randomized to the intervention group (primary surgery, in which the patients with positive pathological circumferential margins (CRM) were subjected to CRT while negative CRM undergone adjuvant chemotherapy according to pathologic staging) or the control group (preoperative CRT, in which all patients were followed by surgery and adjuvant chemotherapy). The primary endpoint was 3-year disease-free survival (DFS).
RESULTS: A total of 275 patients were randomly assigned to intervention (n=140) and control group (n=135), in which 33.57% and 28.15% patients were at clinical T4 stage, 85.92% and 80.45 % patients were at 'bad or ugly' risk in the intervention and control group, respectively. There were two (1.52%) and one (0.77%) patient with positive circumferential margins in the intervention and control groups, respectively (P >0.05). The non-adherence rate for intervention and control group was 3.6% and 23.7%. After a median follow-up of 34.6 (IQR: 18.2-45.7) months, 43 patients had positive events (28 patients and 15 patients in the intervention and control groups, respectively). There were six (4.4%) patients with local recurrence in the intervention group and none in the control group, which led to the stopping of the trial. The 3-year DFS rate was 81.82% (95%CI: 78.18%-85.46%) in the intervention group and 85.37% (95%CI: 81.75%-88.99%) in the control group, with a difference of -3.55% (95%CI: -3.71%- -3.39%) (HR=1.76, 95%CI: 0.94-3.30). In the per protocol dataset, the difference between 3-year DFS rate was -5.44% (95%CI: -5.63%- -5.25%) (HR=2.02, 95%CI: 1.01-4.06).
CONCLUSION: Based on the outcomes of this trial, in patients with LARC and MRI-negative MRF, primary surgery could negatively influence their DFS rates. Therefore, primary surgery was an inferior strategy, compared to preoperative CRT followed by surgery, and cannot be recommended for LARC patients in the clinical practice.
METHOD: This multicenter, open-label, non-inferiority, randomized clinical trial enrolled patients with LARC within 6-12 cm from the anal verge and with negative MRI-predicted MRF. Participants were randomized to the intervention group (primary surgery, in which the patients with positive pathological circumferential margins (CRM) were subjected to CRT while negative CRM undergone adjuvant chemotherapy according to pathologic staging) or the control group (preoperative CRT, in which all patients were followed by surgery and adjuvant chemotherapy). The primary endpoint was 3-year disease-free survival (DFS).
RESULTS: A total of 275 patients were randomly assigned to intervention (n=140) and control group (n=135), in which 33.57% and 28.15% patients were at clinical T4 stage, 85.92% and 80.45 % patients were at 'bad or ugly' risk in the intervention and control group, respectively. There were two (1.52%) and one (0.77%) patient with positive circumferential margins in the intervention and control groups, respectively (P >0.05). The non-adherence rate for intervention and control group was 3.6% and 23.7%. After a median follow-up of 34.6 (IQR: 18.2-45.7) months, 43 patients had positive events (28 patients and 15 patients in the intervention and control groups, respectively). There were six (4.4%) patients with local recurrence in the intervention group and none in the control group, which led to the stopping of the trial. The 3-year DFS rate was 81.82% (95%CI: 78.18%-85.46%) in the intervention group and 85.37% (95%CI: 81.75%-88.99%) in the control group, with a difference of -3.55% (95%CI: -3.71%- -3.39%) (HR=1.76, 95%CI: 0.94-3.30). In the per protocol dataset, the difference between 3-year DFS rate was -5.44% (95%CI: -5.63%- -5.25%) (HR=2.02, 95%CI: 1.01-4.06).
CONCLUSION: Based on the outcomes of this trial, in patients with LARC and MRI-negative MRF, primary surgery could negatively influence their DFS rates. Therefore, primary surgery was an inferior strategy, compared to preoperative CRT followed by surgery, and cannot be recommended for LARC patients in the clinical practice.
Full text links
Related Resources
Trending Papers
Revascularization Strategy in Myocardial Infarction with Multivessel Disease.Journal of Clinical Medicine 2024 March 27
Intravenous infusion of dexmedetomidine during the surgery to prevent postoperative delirium and postoperative cognitive dysfunction undergoing non-cardiac surgery: a meta-analysis of randomized controlled trials.European Journal of Medical Research 2024 April 19
The Tricuspid Valve: A Review of Pathology, Imaging, and Current Treatment Options: A Scientific Statement From the American Heart Association.Circulation 2024 April 26
Consensus Statement on Vitamin D Status Assessment and Supplementation: Whys, Whens, and Hows.Endocrine Reviews 2024 April 28
Management of Diverticulitis: A Review.JAMA Surgery 2024 April 18
Interstitial Lung Disease: A Review.JAMA 2024 April 23
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app
All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.
By using this service, you agree to our terms of use and privacy policy.
Your Privacy Choices
You can now claim free CME credits for this literature searchClaim now
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app