Short-term outcomes of chemoradiotherapy and local excision versus total mesorectal excision in T2-T3ab,N0,M0 rectal cancer: a multicentre randomised, controlled, phase III trial (the TAU-TEM study)
“…An APR rate of 36.3% was reported in the Italian multicentre trial [7]. Better results were reported in the GRECCAR II and TAU‐TEM studies, in which the APR rates were 17.9% and 12.5%, respectively [19, 21].…”
Section: Discussionmentioning
confidence: 99%
“…In most of the studies that consider LE as a diagnostic tool to confirm the tumour response after RCT, an immediate (within 1 month from LE) cTME is proposed to patients with a > ypT1 or margins involved surgical specimen due to the presumed high risk of tumour residue or nodal involvement and, consequently, high risk of local recurrence. The rate of incomplete pathological response after LE ranges between 25% and 46.5% [6, 7, 18, 19, 21]. However, only a part of this group of incomplete responders have truly completed the treatment with cTME after RCT and LE.…”
Section: Discussionmentioning
confidence: 99%
“…Actuarial 5-year disease-free survival.part of this group of incomplete responders have truly completed the treatment with cTME after RCT and LE. In the main studies of organ-sparing surgery in rectal cancer, the rate of patients with unfavourable pathology immediately treated by cTME ranges between 30.8% and 76.5%[6,7,18,19,21]. Therefore, in consideration of the small sample of patients who need and truly undergo cTME because of unfavourable pathology and considering the paucity of studies reporting the short-term and oncological outcomes of this category of rectal cancer patients, we decided to perform a multicentre study within the Italian Society of Surgical Oncology Colorectal Cancer Network (SICO CCN) group to answer some of these questions.…”
AimLocal excision (LE) in selected cases after neoadjuvant radiochemotherapy (RCT) for locally advanced rectal cancer in clinically complete or major responders has been recently reported as an alternative to standard radical resection. Completion total mesorectal excision (cTME) is generally performed when high‐risk pathological features are found in LE surgical specimens. The aim of this study was to evaluate the incidence of residual tumour and lymph node metastases after cTME in patients previously treated by RCT + LE. The secondary aims were to quantify the rate of postoperative morbidity and mortality and to evaluate the long‐term oncological outcome of this group of patients.MethodsAll patients treated from 2007 to 2020 by LE for locally advanced rectal cancer with a clinically complete or major response to RCT who had a subsequent cTME for high‐risk pathological factors (ypT >1 and/or TRG >2 and/or positive margins) were included in this multicentre retrospective study. Pathological data, postoperative short‐term morbidity (classified according to Clavien–Dindo) and mortality and oncological long‐term outcome after cTME were recorded in a database. Statistical analysis was performed using Wizard for iOS version 1.9.31.ResultsA total of 47 patients were included in the study. The rate of R0 resection was 95.7%, and a sphincter‐saving procedure was performed in 37 patients (78.7%), with a protective stoma rate of 78.4%. In 28 cases (59.6%), it was possible to perform a minimally invasive approach. A residual tumour (pT and/or pN) on cTME specimens was found in 21 cases (44.7%). The rate of lymph node metastases was 12.8%. The overall short‐term (within 30 days) postoperative morbidity was 34%, but grade >2 postoperative complications occurred in only nine patients (19.1%), with a reoperation rate of 6.4%. No short‐term postoperative deaths occurred. At a median follow‐up of 57 months (range: 21–174), the long‐term stoma‐free rate was 70.2%, and the actuarial 5‐year overall survival (OS), disease‐free survival (DFS) and local control (LC) were 86.7%, 88.9% and 95.7%, respectively.ConclusionWhen patients exhibit high‐risk pathological factors after RCT + LE, cTME should be suggested due to the high risk of residual tumour or lymph node involvement (44.7%). The results after cTME in terms of the rate of R0 resection, sphincter‐saving procedure, postoperative morbidity and mortality and long‐term oncological outcome seem to be acceptable and do not represent a contraindication to use LE as a first‐step treatment in patients with major or complete clinical response after RCT.
“…An APR rate of 36.3% was reported in the Italian multicentre trial [7]. Better results were reported in the GRECCAR II and TAU‐TEM studies, in which the APR rates were 17.9% and 12.5%, respectively [19, 21].…”
Section: Discussionmentioning
confidence: 99%
“…In most of the studies that consider LE as a diagnostic tool to confirm the tumour response after RCT, an immediate (within 1 month from LE) cTME is proposed to patients with a > ypT1 or margins involved surgical specimen due to the presumed high risk of tumour residue or nodal involvement and, consequently, high risk of local recurrence. The rate of incomplete pathological response after LE ranges between 25% and 46.5% [6, 7, 18, 19, 21]. However, only a part of this group of incomplete responders have truly completed the treatment with cTME after RCT and LE.…”
Section: Discussionmentioning
confidence: 99%
“…Actuarial 5-year disease-free survival.part of this group of incomplete responders have truly completed the treatment with cTME after RCT and LE. In the main studies of organ-sparing surgery in rectal cancer, the rate of patients with unfavourable pathology immediately treated by cTME ranges between 30.8% and 76.5%[6,7,18,19,21]. Therefore, in consideration of the small sample of patients who need and truly undergo cTME because of unfavourable pathology and considering the paucity of studies reporting the short-term and oncological outcomes of this category of rectal cancer patients, we decided to perform a multicentre study within the Italian Society of Surgical Oncology Colorectal Cancer Network (SICO CCN) group to answer some of these questions.…”
AimLocal excision (LE) in selected cases after neoadjuvant radiochemotherapy (RCT) for locally advanced rectal cancer in clinically complete or major responders has been recently reported as an alternative to standard radical resection. Completion total mesorectal excision (cTME) is generally performed when high‐risk pathological features are found in LE surgical specimens. The aim of this study was to evaluate the incidence of residual tumour and lymph node metastases after cTME in patients previously treated by RCT + LE. The secondary aims were to quantify the rate of postoperative morbidity and mortality and to evaluate the long‐term oncological outcome of this group of patients.MethodsAll patients treated from 2007 to 2020 by LE for locally advanced rectal cancer with a clinically complete or major response to RCT who had a subsequent cTME for high‐risk pathological factors (ypT >1 and/or TRG >2 and/or positive margins) were included in this multicentre retrospective study. Pathological data, postoperative short‐term morbidity (classified according to Clavien–Dindo) and mortality and oncological long‐term outcome after cTME were recorded in a database. Statistical analysis was performed using Wizard for iOS version 1.9.31.ResultsA total of 47 patients were included in the study. The rate of R0 resection was 95.7%, and a sphincter‐saving procedure was performed in 37 patients (78.7%), with a protective stoma rate of 78.4%. In 28 cases (59.6%), it was possible to perform a minimally invasive approach. A residual tumour (pT and/or pN) on cTME specimens was found in 21 cases (44.7%). The rate of lymph node metastases was 12.8%. The overall short‐term (within 30 days) postoperative morbidity was 34%, but grade >2 postoperative complications occurred in only nine patients (19.1%), with a reoperation rate of 6.4%. No short‐term postoperative deaths occurred. At a median follow‐up of 57 months (range: 21–174), the long‐term stoma‐free rate was 70.2%, and the actuarial 5‐year overall survival (OS), disease‐free survival (DFS) and local control (LC) were 86.7%, 88.9% and 95.7%, respectively.ConclusionWhen patients exhibit high‐risk pathological factors after RCT + LE, cTME should be suggested due to the high risk of residual tumour or lymph node involvement (44.7%). The results after cTME in terms of the rate of R0 resection, sphincter‐saving procedure, postoperative morbidity and mortality and long‐term oncological outcome seem to be acceptable and do not represent a contraindication to use LE as a first‐step treatment in patients with major or complete clinical response after RCT.
“…Eine weitere Studie von 2023 zeigte eine Überlegenheit der TEM nach neoadjuvanter Radiochemotherapie gegenüber der TME kombiniert mit neoadjuvanten Therapien in Bezug auf Komplikationen und Hospitalisierungsraten bei T2-und T3-Karzinomen (N0, M0). Die Langzeitergebnisse zu Rezidivraten und Lebensqualität stehen aktuell noch aus [37].…”
Zusammenfassung
Einleitung Trotz der Erfindung vor über 40 Jahren hat sich die TEM nicht flächendeckend durchgesetzt. Gründe sind vor allem hohe Anschaffungskosten, die anspruchsvolle Technik und alternative Therapiemöglichkeiten (radikale Resektionsverfahren), die eine größere onkologische Sicherheit bieten. Allerdings kann die Vermeidung großer Bauchoperation mit Stomaanlage und häufigeren Komplikationen das höhere Rezidivrisiko für einige Patienten aufwiegen.Wir untersuchten die Resultate der modifizierten und in der Anschaffung kostengünstigeren V-TEM bei der Resektion von Adenomen und Karzinomen und diskutieren den heutigen Stellenwert des Verfahrens anhand der Literatur.
Methode Zwischen 2003 und 2019 wurden 154 Patienten an 170 Befunden mittels V-TEM operiert. Die Daten zu Operation und Follow-up wurden retrospektiv erhoben und ausgewertet.
Ergebnisse Das mediane Alter betrug 67 Jahre, 89 Patienten waren männlich und 65 weiblich. Die V-TEM wurde bei 79 Karzinomen, 77 Adenomen und 14 sonstigen Befunden eingesetzt. Die Komplikationsrate betrug 21,1%, eine R0-Resektion gelang in 78,8% der Fälle. Die Adenomrezidivrate betrug 7,3%, die Gesamtrezidivrate bei Karzinomen 11,9%, Lokalrezidive traten bei 6,8% auf. Das krankheitsspezifische Überleben betrug 100% nach 5 und 94,2% nach 10 Jahren.
Diskussion Der erfolgreiche Einsatz der TEM bei Adenomen und Frühkarzinomen ist unumstritten. Bei Karzinomen ab einem T1 high risk-Stadium muss jedoch mit Rezidivraten von über 10% gerechnet werden, wohingegen mit radikalen Verfahren bessere Ergebnisse erzielt werden können, weshalb diese als Therapie der Wahl in diesen Fällen gelten. Es gibt jedoch kaum Unterschiede bezüglich der Überlebensraten, zudem bietet die TEM eine bessere postoperative Lebensqualität. Insbesondere auch die Kombination neoadjuvanter Verfahren mit der TEM konnten in der Vergangenheit vielversprechende Ergebnisse bei fortgeschritteneren Stadien liefern. Weitere Studien und die geringeren Anschaffungskosten durch Modifikation zur V-TEM könnten der Methode in Zukunft größere Popularität verleihen.
“…Für ältere oder gebrechliche Patienten können lokale Resektionsverfahren auch dann einen Stellenwert haben, wenn das Risiko für eine onkologische Resektion zu hoch erscheint wie Daten des TREC-Registers zeigen [10]. Eine aktuelle Phase-III-Studie aus Spanien evaluierte eine Kurzzeitradiatio ge-folgt von LE auch für Patienten mit einem lokal begrenzten Stadium (cT2-3a/b), hier stehen allerdings noch Langzeitergebnisse aus [11].…”
ZusammenfassungDie multimodale Therapie des Rektumkarzinoms hat sich über die letzte Dekade erheblich
differenziert je nach Charakteristika des Tumors und Gegebenheiten des Patienten. Die
Operation stellt weiterhin eine wichtige Säule der Therapie dar, deren Qualität von
prognostischer Relevanz für betroffene Patienten ist. Diese Übersicht gibt einen aktuellen
Überblick zur Indikation der verschiedenen chirurgischen Verfahren, aktuellen Entwicklungen
zum perioperativen Management sowie zum Zeitpunkt einer Operation.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.