Discordance in Total Mesorectal Excision Specimen Grading in a Prospective Phase 2 Multicenter Rectal Cancer Trial: Are We Overestimating the Quality of Our Resections?

Autor:	Sylla P; Division of Colon and Rectal Surgery, Mount Sinai Hospital, New York, NY., Berho M; Executive Administration Florida, Cleveland Clinic Florida, Weston, FL., Sands D; Department of Colon and Rectal Surgery, Cleveland Clinic Florida, Weston, FL., Ricardo A; Division of Colon and Rectal Surgery, Mount Sinai Hospital, New York, NY., Bonaccorso A; Division of Colon and Rectal Surgery, Mount Sinai Hospital, New York, NY., Moshier E; Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai Hospital, New York, NY., Hain E; Department of Colon and Rectal Surgery, Mount Sinai Hospital, New York, NY., Letchinger R; Icahn School of Medicine at Mount Sinai Hospital, New York, NY., Marks J; Department of Colorectal Surgery, Lankenau Medical Center, Wynnewood, PA., Whiteford M; Gastrointestinal and Minimally Invasive Surgical Division, the Oregon Clinic Providence Cancer Center, Portland, OR., Mclemore E; Department of Surgery, Division of Colorectal Surgery, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA., Maykel J; Division of Colon and Rectal Surgery, UMass Memorial Medical Center, Worcester, MA., Alavi K; Division of Colon and Rectal Surgery, UMass Memorial Medical Center, Worcester, MA., Zaghiyan K; Division of Colorectal Surgery, Cedars-Sinai Medical Center, Los Angeles, CA., Chadi S; Department of Surgery, Division of Surgical Oncology, Princess Margaret Cancer Centre and University Health Network, Toronto, Ontario, Canada., Shawki SF; Department of Colorectal Surgery, Mayo Clinic, Rochester, MN., Steele S; Department of Surgery, Cleveland Clinic, Cleveland, OH., Pigazzi A; Department of Surgery, Division of Colorectal Surgery, New York-Presbyterian Weill Cornell Medical Center, New York, NY., Albert M; Department of Colon and Rectal Surgery, Advent Health Orlando, Orlando, FL., DeBeche-Adams T; Department of Colon and Rectal Surgery, Advent Health Orlando, Orlando, FL., Polydorides A; Department of Pathology, Mount Sinai Hospital, New York, NY., Wexner S; Ellen Leifer Shulman and Steven Shulman Digestive Disease Center, Cleveland Clinic Florida, Weston, FL.
Jazyk:	angličtina
Zdroj:	Annals of surgery [Ann Surg] 2023 Sep 01; Vol. 278 (3), pp. 452-463. Date of Electronic Publication: 2023 Jul 17.
DOI:	10.1097/SLA.0000000000005948
Abstrakt:	Objectives: To report the results of a rigorous quality control (QC) process in the grading of total mesorectal excision (TME) specimens during a multicenter prospective phase 2 trial of transanal TME. Background: Grading of TME specimens is based on the macroscopic assessment of the mesorectum and standardized through synoptic pathology reporting. TME grade is a strong predictor of outcomes with incomplete (IC) TME associated with increased rates of local recurrence relative to complete or near complete (NC) TME. Although TME grade serves as an endpoint in most rectal cancer trials, in protocols incorporating centralized review of TME specimens for quality assurance, discordance in grading and the management thereof has not been previously described. Methods: A phase 2 prospective transanal TME trial was conducted from 2017 to 2022 across 11 North American centers with TME quality as the primary study endpoint. QC measures included (1) training of site pathologists in TME protocols, (2) blinded grading of de-identified TME specimen photographs by central pathologists, and (3) reconciliation of major discordance before trial reporting. Cohen Kappa statistic was used to assess agreement in grading. Results: Overall agreement in grading of 100 TME specimens between site and central reviewer was rated as fair, (κ = 0.35; 95% CI: 0.10-0.61; P < 0.0001). Concordance was noted in 54%, with minor and major discordance in 32% and 14% of cases, respectively. Upon reconciliation, 13/14 (93%) major discordances were resolved. Pre versus postreconciliation rates of complete or NC and IC TME are 77%/16% and 7% versus 69%/21% and 10%. Reconciliation resulted in a major upgrade (IC-NC; N = 1) or major downgrade (NC/C-IC, N = 4) in 5 cases overall (5%). Conclusions: A 14% rate of major discordance was observed in TME grading between the site and central reviewers. The resolution resulted in a major change in final TME grade in 5% of cases, which suggests that reported rates or TME completeness are likely overestimated in trials. QC through a central review of TME photographs and reconciliation of major discordances is strongly recommended. Competing Interests: P.S. reports consultant payments from Ethicon, Medtronic, Safeheal, Olympus, Stryker, RedDress, and GI windows. A. Polydorides reports royalties or licenses with Elsevier, Med Learning Group, payment or honoraria from Johns Hopkins and USCAP, and payment for various expert testimony. J. Marks serves as a consultant for Stryker and Intuitive, reports payment or honoraria from Stryker and Medtronic, and participates on the data safety monitoring board (DSMB) or advisory board for Virtual Incision. E. McLemore serves as a chair on the SAGES Colorectal Surgery Committee. J. Maykel reports consultant fees for Olympus, Takeda, Safeheal, RedDress, and Applied Medical, and payment for expert testimony for medical legal review. K.A. reports consultant fees for Safeheal and Olympus, payment for expert testimony for CRICO, and serves on the DCR editorial board and as an Operative Competency Committee Chair of ASCRS. K.Z. reports grants received by Surgical Research Network and Crohn’s & Colitis Foundation, consultant fees for Takeda and Intuitive, and payment or honoraria from Natera. S.C serves as a consultant for Stryker and Noah Medical and receives payment or honoraria from Stryker. A. Pigazzi reports receiving a Research grant from Vioptix, royalties with Xodus Medical, and serves as a consultant for Medtronic, Ethicon, and Intuitive. M.A. reports grants or contracts from Applied Medical, Stryker Endoscopy, Conmed, Human Extensions, Endoquest, Livsmed, Astellas Pharmaceuticals, Distal Motion, Proximie and Noah, serves as a consultant and receives payment or honoraria from Applied Medical, Stryker, Distal Motion, EndoQuest, Astellas Pharmaceuticals, Livsmed and ConMed, participates on the DSMB or Advisory board for Proximie and Distal Motion, and hold stock or stock options for Applied Medical, Proximie and Human Extension. T.D.A receives personal honoraria for educational courses with support for travel expenses from Applied Medical. S.W. receives consulting fees from ARC/Corvus, Baxter, Becton Dickinson, GI Supply, ICON Clinical Research Limited, Intuitive Surgical, Leading BioSciences, Leading Biosciences/Pallisade Bio, Livsmed, Medtronic, Olympus, Stryker, and Takeda and receives royalties from Intuitive Surgical, Karl Storz Endoscopy America Inc, Medtronic, and Unique Surgical Innovations LLC. The remaining authors report no conflicts of interest. (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)
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