Non-Operative Management Versus Total Mesorectal Excision for Locally Advanced Rectal Cancer with Clinical Complete Response After Neoadjuvant Chemoradiotherapy: a GRADE Approach by the Rectal Cancer Guidelines Writing Group of the Italian Association of Medical Oncology (AIOM)

Giulia Capelli, Irene De Simone, Gaya Spolverato, Michela Cinquini, Ivan Moschetti, Sara Lonardi, Gianluca Masi, Chiara Carlomagno, Domenico Corsi, Gabriele Luppi, Maria Antonietta Gambacorta, Francesca Valvo, Renato Cannizzaro, Federica Grillo, Brunella Barbaro, Angelo Restivo, Marco Messina, Alessandro Pastorino, Carlo Aschele, Salvatore Pucciarelli

Research output: Contribution to journalReview articlepeer-review

Abstract

BACKGROUND: The standard approach for locally advanced rectal cancer (LARC) is neoadjuvant chemoradiotherapy (nCRT) followed by total mesorectal excision (TME). After nCRT 20% of patients achieve a clinical complete response (pCR) and could be treated with a non-operative management (NOM).

METHODS: The panel of the Italian Association of Medical Oncology (AIOM) Guidelines on rectal cancer applied the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach addressing the following question: Should NOM vs. TME be used for patients with rectal cancer with clinical complete response after nCRT? Five outcomes were identified: disease-free survival (DFS), mortality, local recurrence, colostomy rate, and functional outcomes.

RESULTS: Nine studies were included in the analysis. A higher risk of disease recurrence was observed in the NOM group compared to the TME group (RR = 1.69, 95% CI 1.08, 2.64) on the other hand, we observed a slightly positive but not significant effect on mortality of NOM (RR = 0.82, 95% CI 0.46, 1.45). Patients in the NOM group were more likely to experience local recurrence (RR = 5.37, 95% CI 2.56, 11.27) and patients in the TME group were more likely to have a permanent colostomy (RR = 0.15, 95% CI 0.08, 0.29). Only one study evaluated functional outcomes. The overall certainty of evidence was rated as very low.

CONCLUSIONS: NOM was found to correlate with a higher risk of local recurrence which did not translate in worse OS and a lower colostomy rate. Due to the paucity of evidences, no recommendations are possible. NOM remains an experimental treatment; thus, patients managed with NOM should be enrolled in clinical trials with a dedicated follow-up schedule.

Original languageEnglish
Pages (from-to)2150-2159
Number of pages10
JournalJournal of Gastrointestinal Surgery
Volume24
Issue number9
DOIs
Publication statusPublished - Sep 2020

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