Background. Patients with mid-low rectal cancer enrolled in a rectal-sparing approach may require Total mesorectal excision (TME) due to high-risk histopathological features, local regrowth or recurrence, and may have a compromised surgical outcomes and survival. Aim. This study aims to evaluate the short- and long-term outcomes of patients undergoing completion or salvage TME after a rectal-sparing approach. Methods. This is a sub-analysis of the ReSARCh study (NCT02710812, clinicaltrials.gov), which is a multicentre, prospective, observational study including patients with complete or major clinical response after neoadjuvant treatment for locally advanced rectal cancer. Patients were treated with local excision (LE) in case of complete or major response, or with Watch-and-wait (WW) in case of complete response, at the discretion of the clinicians/patients. Patients who required a completion TME for unfavourable histopathology after LE or a salvage TME for local recurrence or local regrowth, were included in this analysis. Stoma rate, 30-day complications and 30-day mortality after TME were collected. An intention-to-treat analysis of patients who required TME was performed and overall survival (OS), disease-free survival (DFS), local recurrence-free survival (LRFS) and distant recurrence-free survival (DRFS) were estimated using the Kaplan-Meier method. Results. Between April 2016 and April 2023, a total of 299 patients were enrolled in the ReSARCh study and a total of 190 patients were available for analysis. Of these, 66 (34.7%) were selected for this study. Of them, 45 (68.2%) initially underwent LE, while the other 21 (31.8%) followed WW approach. Completion TME was necessary in 36 (54.5%) patients, while salvage TME was required in 9 (13.6%) patients for local recurrence after LE and in 21 (31.8%) patients for local regrowth after WW approach. A total of 40 (60.6%) TMEs were performed, including 28 low anterior resections, 11 abdominoperineal resections and 1 pelvic exenteration. The overall 30-day post-operative complications rate was 32.5%, of which 6 (15.0%) were major (Clavien-Dindo≥3), and the 30-day mortality was 2.5%. At a median follow-up of 38 (31.2-48.7) months, the stoma-free rate was 87.5% and the 1-, 3- and 5-year OS and DFS were 100%, 98.5%, 94.0% and 87.7%, 77.9%, 64.6%, respectively, while the 1-, 3- and 5-year LRFS and DRFS were 93.9%, 86.0%, 83.5% and 97.0%, 93.3%, 93.3%, respectively. Conclusions. About one third of the patients required TME after an initial rectal-sparing approach. TME after a rectal-sparing approach is safe and feasible, as the rate of major post-operative complications and mortality are acceptable. Survival of patients requiring TME after LE or WW is not compromised and is characterized by a low recurrence rate. Most patients treated with cTME showed no residual tumour on histopathological analysis and had no recurrence. The criteria for recommending completion surgery should be redefined.
Presupposti. I pazienti con cancro del retto medio-basso sottoposti ad approcci conservativi del dell’organo potrebbero necessitare di un’escissione totale del mesoretto (TME) per caratteristiche istopatologiche ad elevato rischio o per recidiva locale, e potrebbero avere una compromissione sia degli esiti chirurgici sia della sopravvivenza. Obiettivo. L’obiettivo di questo studio è di valutare gli esiti di lungo e breve termine nei pazienti che si sono sottoposti a una chirurgia di completamento o di salvataggio dopo un approccio conservativo del retto. Metodi. Lo studio rappresenta una sub-analisi del protocollo ReSARCh (registrato come NCT02710812, clinicaltrials.gov), uno studio multicentrico, prospettico e osservazionale che include pazienti con una risposta clinica completa (cCR) o maggiore (mCR) al trattamento neoadiuvante per il cancro del retto localmente avanzato. I pazienti sono stati trattati con escissione locale (LE) in caso di risposta clinica completa o maggiore, o con regime di sorveglianza (WW) in caso di risposta clinica completa, a discrezione del medico e del paziente. I pazienti che hanno richiesto una TME di completamento per caratteristiche istopatologiche sfavorevoli dopo LE, o che hanno richiesto una TME di salvataggio dopo recidiva locale sono stati inclusi nell’analisi. I dati raccolti riguardavano il tasso di stomia, le complicanze post-operatorie a 30 giorni e la mortalità a 30 giorni dalla TME. È stata eseguita un’analisi intention-to-treat dei pazienti che necessitavano di una TME, e la sopravvivenza globale (OS), la sopravvivenza libera da malattia (DFS), la sopravvivenza libera da recidiva locale (LRFS) e la sopravvivenza libera da recidiva a distanza (DRFS) sono state stimate attraverso l’utilizzo delle curve di Kaplan-Meier. Risultati. Tra aprile 2016 ed aprile 2023, un totale di 299 pazienti sono stati inclusi nel protocollo ReSARCh, e di questi, 190 erano congrui per l’analisi. 66 (34.7%) pazienti sono stati selezionati per lo studio. Di questi, 45 (68.2%) si sono sottoposti a LE, i restanti 21 (31.8%) hanno seguito un regime di WW. La TME di completamento è stata richiesta in 36 (54.5%) pazienti, mentre la TME di salvataggio è stata richiesta in 9 (13.6%) pazienti nel gruppo LE e in 21 (31.8%) pazienti nel gruppo WW a seguito di una recidiva. In totale sono state eseguite 40 (60.6%) TME, includendo 28 resezioni anteriori di retto, 11 resezioni addomino-perineali e 1 exenteratio pelvica. Il tasso di complicanze post-operatorie a 30 giorni è stato di 32.5%, di cui 6 (15.0%) sono state complicanze maggiori (secondo la classificazione Clavien-Dindo≥3), e la mortalità è stata del 2.5%. Al follow-up medio di 38 mesi (31.2-48.7), il tasso di pazienti senza stomia è stato dell’87.5% e l’OS a 1, 3 e 5 anni è stata rispettivamente del 100%, 98.5%, 94.0%; la DFS del 87.7%, 77.9%, 64.6%; mentre la LRFS e la DRFS a 1, 3 e 5 anni sono state rispettivamente del 93.9%, 86.0%, 83.5% e del 97.0%, 93.3%, 93.3%. Conclusioni. Circa un terzo dei pazienti selezionati per un approccio conservativo del retto hanno richiesto una TME durante il follow-up. La TME dopo un approccio conservativo del retto è sicura e attuabile, poiché le complicanze post-chirurgiche maggiori e la mortalità risultano essere accettabili. La sopravvivenza dei pazienti che hanno richiesto una TME dopo LE o WW non è stata compromessa ed è caratterizzata da un basso tasso di recidiva. La maggior parte dei pazienti trattati con TME di completamento, all’analisi istopatologica, non ha riportato la presenza di tumore e, inoltre, non ha avuto recidiva. I criteri per raccomandare la chirurgia di completamento dovrebbero essere, quindi, ridefiniti.
Long and short-term outcomes of completion and salvage total mesorectal excision after rectal-sparing approaches.
CODATO, SARA
2022/2023
Abstract
Background. Patients with mid-low rectal cancer enrolled in a rectal-sparing approach may require Total mesorectal excision (TME) due to high-risk histopathological features, local regrowth or recurrence, and may have a compromised surgical outcomes and survival. Aim. This study aims to evaluate the short- and long-term outcomes of patients undergoing completion or salvage TME after a rectal-sparing approach. Methods. This is a sub-analysis of the ReSARCh study (NCT02710812, clinicaltrials.gov), which is a multicentre, prospective, observational study including patients with complete or major clinical response after neoadjuvant treatment for locally advanced rectal cancer. Patients were treated with local excision (LE) in case of complete or major response, or with Watch-and-wait (WW) in case of complete response, at the discretion of the clinicians/patients. Patients who required a completion TME for unfavourable histopathology after LE or a salvage TME for local recurrence or local regrowth, were included in this analysis. Stoma rate, 30-day complications and 30-day mortality after TME were collected. An intention-to-treat analysis of patients who required TME was performed and overall survival (OS), disease-free survival (DFS), local recurrence-free survival (LRFS) and distant recurrence-free survival (DRFS) were estimated using the Kaplan-Meier method. Results. Between April 2016 and April 2023, a total of 299 patients were enrolled in the ReSARCh study and a total of 190 patients were available for analysis. Of these, 66 (34.7%) were selected for this study. Of them, 45 (68.2%) initially underwent LE, while the other 21 (31.8%) followed WW approach. Completion TME was necessary in 36 (54.5%) patients, while salvage TME was required in 9 (13.6%) patients for local recurrence after LE and in 21 (31.8%) patients for local regrowth after WW approach. A total of 40 (60.6%) TMEs were performed, including 28 low anterior resections, 11 abdominoperineal resections and 1 pelvic exenteration. The overall 30-day post-operative complications rate was 32.5%, of which 6 (15.0%) were major (Clavien-Dindo≥3), and the 30-day mortality was 2.5%. At a median follow-up of 38 (31.2-48.7) months, the stoma-free rate was 87.5% and the 1-, 3- and 5-year OS and DFS were 100%, 98.5%, 94.0% and 87.7%, 77.9%, 64.6%, respectively, while the 1-, 3- and 5-year LRFS and DRFS were 93.9%, 86.0%, 83.5% and 97.0%, 93.3%, 93.3%, respectively. Conclusions. About one third of the patients required TME after an initial rectal-sparing approach. TME after a rectal-sparing approach is safe and feasible, as the rate of major post-operative complications and mortality are acceptable. Survival of patients requiring TME after LE or WW is not compromised and is characterized by a low recurrence rate. Most patients treated with cTME showed no residual tumour on histopathological analysis and had no recurrence. The criteria for recommending completion surgery should be redefined.File | Dimensione | Formato | |
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https://hdl.handle.net/20.500.12608/47046