Avoidance of Overtreatment of Rectal Cancer by Selective Chemoradiotherapy: Results of the Optimized Surgery and MRI-Based Multimodal Therapy Trial.
Adult
Aged
Aged, 80 and over
Carcinoma
/ diagnosis
Case-Control Studies
Chemoradiotherapy, Adjuvant
/ adverse effects
Disease-Free Survival
Female
Follow-Up Studies
Humans
Magnetic Resonance Imaging
Male
Medical Overuse
/ economics
Middle Aged
Neoadjuvant Therapy
/ adverse effects
Neoplasm Recurrence, Local
/ epidemiology
Neoplasm Staging
Practice Guidelines as Topic
Proctectomy
Prospective Studies
Rectal Neoplasms
/ diagnosis
Rectum
/ diagnostic imaging
Journal
Journal of the American College of Surgeons
ISSN: 1879-1190
Titre abrégé: J Am Coll Surg
Pays: United States
ID NLM: 9431305
Informations de publication
Date de publication:
10 2020
10 2020
Historique:
received:
29
05
2020
revised:
22
06
2020
accepted:
23
06
2020
pubmed:
23
7
2020
medline:
26
3
2021
entrez:
23
7
2020
Statut:
ppublish
Résumé
Neoadjuvant 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. In 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. Of 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. The 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).
Sections du résumé
BACKGROUND
Neoadjuvant 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 DESIGN
In 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.
RESULTS
Of 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.
CONCLUSIONS
The 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).
Identifiants
pubmed: 32697965
pii: S1072-7515(20)30551-2
doi: 10.1016/j.jamcollsurg.2020.06.023
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT01325649']
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
413-425.e2Investigateurs
Martin E Kreis
(ME)
Guenther Winde
(G)
Rena Thomasmeyer
(R)
Sigmar Stelzner
(S)
Cornelius Bambauer
(C)
Soenke Scheunemann
(S)
Axel Faedrich
(A)
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2020 American College of Surgeons. Published by Elsevier Inc. All rights reserved.