Non-inferiority multicenter prospective randomized controlled study of rectal cancer T2–T3s (superficial) N0, M0 undergoing neoadjuvant treatment and local excision (TEM) vs total mesorectal excision (TME)

Serra‐Aracil, Xavier; Pericay, Carles; Mora, Laura; Targarona, Eduardo M.; Delgado, Salvadora; Reina, Angel Antonio Pozuelo; Vallribera, Francesc; Navascués, Jose María Enriquez; Serra-Pla, S; Garcia-Pacheco, Juan Carlos

doi:10.1007/s00384-017-2942-1

Cited by 24 publications

(9 citation statements)

References 46 publications

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“…Alternative approaches are currently being explored in an effort to reduce the morbidity and mortality associated with TME for LARC. The TAU-TEM (NCT01308190)[ 170 ] and STAR-TREC trials (NCT02945566)[ 171 ] are both evaluating the viability of less aggressive surgical approaches in these patients. The results of these trials are expected to provide data comparing this alternative surgical approach to standard treatment and watch and wait.…”

Section: Future Perspectivesmentioning

confidence: 99%

Watch and wait approach in rectal cancer: Current controversies and future directions

López-Campos¹,

Martín²,

Pérez³

et al. 2020

WJG

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According to the main international clinical guidelines, the recommended treatment for locally-advanced rectal cancer is neoadjuvant chemoradiotherapy followed by surgery. However, doubts have been raised about the appropriate definition of clinical complete response (cCR) after neoadjuvant therapy and the role of surgery in patients who achieve a cCR. Surgical resection is associated with significant morbidity and decreased quality of life (QoL), which is especially relevant given the favourable prognosis in this patient subset. Accordingly, there has been a growing interest in alternative approaches with less morbidity, including the organ-preserving watch and wait strategy, in which surgery is omitted in patients who have achieved a cCR. These patients are managed with a specific follow-up protocol to ensure adequate cancer control, including the early identification of recurrent disease. However, there are several open questions about this strategy, including patient selection, the clinical and radiological criteria to accurately determine cCR, the duration of neoadjuvant treatment, the role of dose intensification (chemotherapy and/or radiotherapy), optimal follow-up protocols, and the future perspectives of this approach. In the present review, we summarize the available evidence on the watch and wait strategy in this clinical scenario, including ongoing clinical trials, QoL in these patients, and the controversies surrounding this treatment approach.

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Section: Future Perspectivesmentioning

confidence: 99%

Watch and wait approach in rectal cancer: Current controversies and future directions

López-Campos¹,

Martín²,

Pérez³

et al. 2020

WJG

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“…Surgical approaches for early rectal cancer have mainly focused on radical oncological resection by total mesorectal excision (TME) . Over the past two decades, local excision of early rectal cancer has become an accepted treatment in selected patients, with the advantages of reduced postoperative morbidity and mortality, less impairment of quality of life and equivalent oncological results compared with radical surgery . Importantly, there is evidence that recurrence and survival rates after local excision are comparable with those of radical surgery .…”

Section: Introductionmentioning

confidence: 99%

Transanal endoscopic microsurgery for rectal lesions in a specialist regional early rectal cancer centre: the Mersey experience

et al. 2019

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AimOrgan‐preserving local excision by transanal endoscopic microsurgery (TEM) for early rectal cancer offers significantly lower morbidity as compared to formal rectal cancer resection with acceptable outcomes. This study presents our 6‐year experience of TEM for rectal lesions referred to a specialist early rectal cancer centre in the UK.MethodData were collected for all patients referred for TEM of suspected early rectal cancer to a regional specialist early rectal cancer multidisciplinary team (MDT) over a 6‐year period.ResultsOne hundred and forty‐one patients who underwent full‐thickness TEM for suspected or confirmed early rectal cancer were included. Thirty patients were referred for TEM following incomplete endoscopic polypectomy. Final pathology was benign in 77 (54.6%) cases and malignant in 64 (45.4%). Of the 61 confirmed adenocarcinomas, TEM resections were pT0 in 17 (27.9%), pT1 in 32 (51.7%), pT2 in 11 (18.0%) and pT3 in 1 (1.6%). Thirty‐eight of 61 patients (62.3%) had one or more poor histological prognostic features and these patients were offered further treatment. Twenty‐three of 61 (37.7%) patients with rectal adenocarcinoma required no further treatment following TEM. Forty‐three cases of rectal adenocarcinoma were available for establishing recurrence rates. Two of 43 patients (4.7%) developed a recurrence at a median follow‐up of 28.7 months (12.1–66.5 months). The overall estimated 5‐year overall survival rate was 87.9% and the disease‐free survival rate was 82.9%.ConclusionAcceptable outcomes are possible for TEM surgery with appropriate patient selection, effective technique, expert histopathology, appropriate referral for adjuvant treatment and meticulous follow‐up. This can be achieved through an early rectal cancer MDT in a dedicated specialist regional centre.

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“…The limitations of this study were its retrospective design and the small sample size, but a randomized controlled trial is ongoing. 42…”

Section: Discussionmentioning

confidence: 99%

Transanal Endoscopic Microsurgery Versus Total Mesorectal Excision in ypT0-1 Rectal Cancer After Preoperative Radiochemotherapy: Postoperative Morbidity, Functional Results, and Long-term Oncologic Outcome

Rizzo

Pafundi

Sionne

et al. 2022

Diseases of the Colon &Amp; Rectum

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BACKGROUND:In patients with locally advanced extraperitoneal rectal cancer, a multidisciplinary approach represents the standard treatment. However, considering the favorable prognosis in patients with major or complete response, radical surgery might represent overtreatment. OBJECTIVE:This study aimed to evaluate postoperative short-term morbidity, functional outcome, and oncologic long-term outcome in patients with rectal cancer treated with local excision by transanal endoscopic microsurgery or radical surgery and to determine who achieved a complete or major pathological response (ypT0-1) after neoadjuvant treatment. DESIGN:This was a retrospective study. SETTING:The study was conducted at a single center.PATIENTS: Patients who had received neoadjuvant treatment by local excision with a major or complete pathological response at histological examination (transanal endoscopic microsurgery group) were compared to patients treated by radical surgery with the same pathological response (total mesorectal excision group). INTERVENTIONS:The interventions included local excision by transanal endoscopic microsurgery and radical surgery with total mesorectal excision. MAIN OUTCOME MEASURES:Postoperative short-term morbidity, functional outcome 1 year after surgery, and oncologic long-term outcome were measured.RESULTS: Ninety-three patients were included in the study (35 in the transanal endoscopic microsurgery group and 58 in the mesorectal excision group). In the total mesorectal excision group, a sphincter-saving approach was possible in 89.7% (vs 100%; p = 0.049); a protective temporary stoma was necessary in 74.1% of radical procedures (vs 0%; p < 0.001), and 13.8% of these became permanent. Short-term postoperative morbidity was lower after local excision (14.3% vs 46.6%; p = 0.002). One year after surgery, the transanal endoscopic microsurgery group recorded better evacuation and continence function than the total mesorectal excision group. Oncologic outcome was similar between the groups.

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Non-inferiority multicenter prospective randomized controlled study of rectal cancer T2–T3s (superficial) N0, M0 undergoing neoadjuvant treatment and local excision (TEM) vs total mesorectal excision (TME)

Abstract: ClinicalTrials.gov identifier: NCT01308190. Número de registro del Comité de Etica e Investigación Clínica (CEIC) del Hospital universitario Parc Taulí: TAU-TEM-2009-01.

Cited by 24 publications

References 46 publications

Watch and wait approach in rectal cancer: Current controversies and future directions

Watch and wait approach in rectal cancer: Current controversies and future directions

Transanal endoscopic microsurgery for rectal lesions in a specialist regional early rectal cancer centre: the Mersey experience

Transanal Endoscopic Microsurgery Versus Total Mesorectal Excision in ypT0-1 Rectal Cancer After Preoperative Radiochemotherapy: Postoperative Morbidity, Functional Results, and Long-term Oncologic Outcome

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