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Open Access 12-12-2023 | Colon Cancer | Colorectal Cancer

A Randomized Phase III Trial of Complete Mesocolic Excision Compared with Conventional Surgery for Right Colon Cancer: Interim Analysis of a Nationwide Multicenter Study of the Italian Society of Surgical Oncology Colorectal Cancer Network (CoME-in trial)

Authors: Maurizio Degiuli, MD, Aridai H. Resendiz Aguilar, MD, Mario Solej, MD, Danila Azzolina, MA, PhD, Giulia Marchiori, MD, Francesco Corcione, MD, Umberto Bracale, MD, PhD, FACS, Roberto Peltrini, MD, Maria M. Di Nuzzo, MD, Gianandrea Baldazzi, MD, Diletta Cassini, MD, Giuseppe S. Sica, MD, Brunella Pirozzi, MD, Andrea Muratore, MD, Marcello Calabrò, MD, Elio Jovine, MD, FACS, Raffaele Lombardi, MD, Gabriele Anania, MD, Matteo Chiozza, MD, Wanda Petz, MD, Paolo Pizzini, MD, Roberto Persiani, MD, Alberto Biondi, MD, Rossella Reddavid, MD, PhD

Published in: Annals of Surgical Oncology | Issue 3/2024

Abstract

Background

Although complete mesocolic excision (CME) is supposed to be associated with a higher lymph node (LN) yield, decreased local recurrence, and survival improvement, its implementation currently is debated because the evidence level of these data is rather low and still not supported by randomized controlled trials.

Method

This is a multicenter, randomized, superiority trial (NCT04871399). The 3-year disease-free survival (DFS) was the primary end point of the study. The secondary end points were safety (duration of operation, perioperative complications, hospital length of stay), oncologic outcomes (number of LNs retrieved, 3- and 5-year overall survival, 5-year DFS), and surgery quality (specimen length, area and integrity rate of mesentery, length of ileocolic and middle-colic vessels). The trial design required the LN yield to be higher in the CME group at interim analysis.

Results

Interim data analysis is presented in this report. The study enrolled 258 patients in nine referral centers. The number of LNs retrieved was significantly higher after CME (25 vs. 20; p = 0.012). No differences were observed with respect to intra- or post-operative complications, postoperative mortality, or duration of surgery. The hospital stay was even shorter after CME (p = 0.039). Quality of surgery indicators were higher in the CME arm of the study. Survival data still were not available.

Conclusions

Interim data show that CME for right colon cancer in referral centers is safe and feasible and does not increase perioperative complications. The study documented with evidence that quality of surgery and LN yield are higher after CME, and this is essential for continuation of patient recruitment and implementation of an optimal comparison.

Trial registration The trial was registered at ClinicalTrials.gov with the code NCT04871399 and with the acronym CoME-In trial.

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Title: A Randomized Phase III Trial of Complete Mesocolic Excision Compared with Conventional Surgery for Right Colon Cancer: Interim Analysis of a Nationwide Multicenter Study of the Italian Society of Surgical Oncology Colorectal Cancer Network (CoME-in trial)
Authors: Maurizio Degiuli, MD
Aridai H. Resendiz Aguilar, MD
Mario Solej, MD
Danila Azzolina, MA, PhD
Giulia Marchiori, MD
Francesco Corcione, MD
Umberto Bracale, MD, PhD, FACS
Roberto Peltrini, MD
Maria M. Di Nuzzo, MD
Gianandrea Baldazzi, MD
Diletta Cassini, MD
Giuseppe S. Sica, MD
Brunella Pirozzi, MD
Andrea Muratore, MD
Marcello Calabrò, MD
Elio Jovine, MD, FACS
Raffaele Lombardi, MD
Gabriele Anania, MD
Matteo Chiozza, MD
Wanda Petz, MD
Paolo Pizzini, MD
Roberto Persiani, MD
Alberto Biondi, MD
Rossella Reddavid, MD, PhD
Publication date: 12-12-2023
Publisher: Springer International Publishing
Keywords: Colon Cancer
Colon Cancer
Hemicolectomy
Hemicolectomy
Lymphadenectomy
Published in: Annals of Surgical Oncology / Issue 3/2024
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI: https://doi.org/10.1245/s10434-023-14664-0

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Springer Medicine

A Randomized Phase III Trial of Complete Mesocolic Excision Compared with Conventional Surgery for Right Colon Cancer: Interim Analysis of a Nationwide Multicenter Study of the Italian Society of Surgical Oncology Colorectal Cancer Network (CoME-in trial)

Abstract

Background

Method

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Method

Results

Conclusions

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