Format

Send to

Choose Destination
Gastrointest Endosc. 2016 Jul;84(1):115-125.e4. doi: 10.1016/j.gie.2015.12.029. Epub 2016 Jan 6.

A proposed staging system and stage-specific interventions for familial adenomatous polyposis.

Author information

1
Department of Gastroenterology, Hepatology, and Nutrition, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
2
Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
3
Department of Biostatistics, West Virginia University Health Sciences Center, Morgantown, West Virginia, USA.
4
Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
5
Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
6
Department of Digestive Tract and General Surgery, Saitama Medical University, Saitama, Japan.
7
Division of Surgical Oncology, Hereditary Cancer Registry, Hospital Sirio Libanes, Sao Paulo, Brazil.
8
Department of Gastroenterology, Institut de Malalties Digestives i Metabòliques, Hospital Clinic, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain.
9
Division of Internal Medicine, University of Michigan Health System, Ann Arbor, Michigan, USA.
10
Section of Colon and Rectal Surgery, Washington University School of Medicine, St. Louis, Missouri, USA.
11
Unit of Hereditary Digestive Tract Tumors, Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan, Italy.
12
Wolfson Unit for Endoscopy, St. Marks Hospital, Harrow, Middlesex, United Kingdom.
13
Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USA.
14
Department of Medical and Surgical Sciences, S. Orsola-Malpighi University Hospital, Bologna, Italy.
15
Division of Gastroenterology, Department of Veterans Affairs Eastern Colorado Health Care System and University of Colorado School of Medicine, Denver, Colorado, USA.
16
Department of Surgery, Hyogo College of Medicine, Hyogo, Japan.
17
The Danish Polyposis Register, Gastrointestinal Unit, Hvidovre University Hospital, Copenhagen, Denmark.
18
The Polyposis Registry, St. Mark's Hospital, Harrow, Middlesex, United Kingdom.
19
Division of Gastroenterology, Hepatology and Nutrition, Nationwide Children's Hospital, The Ohio State University, Columbus, Ohio, USA.
20
Gastroenterology and Nutrition Service, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.
21
Department of Surgical Gastroenterology, Aalborg Universitetshospital, Aalborg, Denmark.
22
Division of Population Sciences, Division of Gastroenterology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts, USA.
23
Center for Hereditary Tumors, HELIOS Klinikum Wuppertal, University Witten-Herdecke, Wuppertal, Germany.

Abstract

BACKGROUND AND AIMS:

It is not possible to accurately count adenomas in many patients with familial adenomatous polyposis (FAP). Nevertheless, polyp counts are critical in evaluating each patient's response to interventions. However, the U.S. Food and Drug Administration no longer recognizes the decrease in polyp burden as a sufficient chemoprevention trial treatment endpoint requiring a measure of "clinical benefit." To develop endpoints for future industry-sponsored chemopreventive trials, the International Society for Gastrointestinal Hereditary Tumors (InSIGHT) developed an FAP staging and intervention classification scheme for lower-GI tract polyposis.

METHODS:

Twenty-four colonoscopy or sigmoidoscopy videos were reviewed by 26 clinicians familiar with diagnosis and treatment of FAP. The reviewers independently assigned a stage to a case by using the proposed system and chose a stage-specific intervention for each case. Our endpoint was the degree of concordance among reviewers staging and intervention assessments.

RESULTS:

The staging and intervention ratings of the 26 reviewers were highly concordant (ρ = 0.710; 95% credible interval, 0.651-0.759). Sixty-two percent of reviewers agreed on the FAP stage, and 90% of scores were within ±1 stage of the mode. Sixty percent of reviewers agreed on the intervention, and 86% chose an intervention within ±1 level of the mode.

CONCLUSIONS:

The proposed FAP colon polyposis staging system and stage-specific intervention are based on a high degree of agreement on the part of experts in the review of individual cases of polyposis. Therefore, reliable and clinically relevant means for measuring trial outcomes can be developed. Outlier cases showing wide scatter in stage assignment call for individualized attention and may be inappropriate for enrollment in clinical trials for this reason.

PMID:
26769407
PMCID:
PMC5570515
DOI:
10.1016/j.gie.2015.12.029
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Elsevier Science Icon for PubMed Central
Loading ...
Support Center