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Review
. 2020 Sep;24(9):2150-2159.
doi: 10.1007/s11605-020-04635-1. Epub 2020 May 11.

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  1 , Irene De Simone  2 , Gaya Spolverato  3 , Michela Cinquini  2 , Ivan Moschetti  2 , Sara Lonardi  4 , Gianluca Masi  5 , Chiara Carlomagno  6 , Domenico Corsi  7 , Gabriele Luppi  8 , Maria Antonietta Gambacorta  9 , Francesca Valvo  10 , Renato Cannizzaro  11 , Federica Grillo  12 , Brunella Barbaro  9 , Angelo Restivo  13 , Marco Messina  14 , Alessandro Pastorino  15 , Carlo Aschele  15 , Salvatore Pucciarelli  15
Affiliations
Free article
Review

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 et al. J Gastrointest Surg. 2020 Sep.
Free article

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.

Keywords: GRADE; Metanalysis; Neoadjuvant chemotherapy; Rectal cancer; Surgery.

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