Randomized Clinical Trial
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. May 7, 2015; 21(17): 5352-5358
Published online May 7, 2015. doi: 10.3748/wjg.v21.i17.5352
Gastrointestinal perforation in metastatic colorectal cancer patients with peritoneal metastases receiving bevacizumab
Aflah Roohullah, Hui-Li Wong, Katrin M Sjoquist, Peter Gibbs, Kathryn Field, Ben Tran, Jeremy Shapiro, Joe Mckendrick, Desmond Yip, Louise Nott, Val Gebski, Weng Ng, Wei Chua, Timothy Price, Niall Tebbutt, Lorraine Chantrill
Aflah Roohullah, Lorraine Chantrill, Macarthur Cancer Therapy Centre, Campbelltown, NSW 2560, Australia
Aflah Roohullah, Katrin M Sjoquist, Val Gebski, NHMRC Clinical Trials Centre, Camperdown, NSW 2050, Australia
Hui-Li Wong, Peter Gibbs, Kathryn Field, Ben Tran, Department of Medical Oncology, Royal Melbourne Hospital, Parkville, VIC 3052, Australia
Hui-Li Wong, Peter Gibbs, Ben Tran, Melbourne Medical School, University of Melbourne, Melbourne, VIC 3000, Australia
Hui-Li Wong, Joe Mckendrick, Department of Medical Oncology, Box Hill Hospital, Box Hill, VIC 3128, Australia
Katrin M Sjoquist, St George Cancer Care Centre, Kogarah, NSW 2217, Australia
Peter Gibbs, Ben Tran, Department of Medical Oncology, Western Hospital, Footscray, VIC 3011, Australia
Jeremy Shapiro, Department of Medical Oncology, Cabrini Health, Melbourne, VIC 3000, Australia
Desmond Yip, Department of Medical Oncology, the Canberra Hospital, Garran, ACT 2605, Australia
Desmond Yip, ANU Medical School, Australia National University, Canberra, ACT 2600, Australia
Louise Nott, Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS 7000, Australia
Weng Ng, Wei Chua, Liverpool Cancer Therapy Centre, Liverpool, NSW 2170, Australia
Timothy Price, Department of Medical Oncology, the Queen Elizabeth Hospital, Woodville, SA 5011, Australia
Niall Tebbutt, Department of Medical Oncology, Austin Health, Heidelberg, VIC 3084, Australia
Lorraine Chantrill, the Kinghorn Cancer Centre, Garvan Institute of Medical Research, Darlinghurst, NSW 2010, Australia
Author contributions: Roohullah A, Sjoquist KM, Gebski V and Chantrill L designed the research; Roohullah A and Gebski V analysed the data; all authors performed the research and contributed to writing the paper.
Supported by the National Health and Medical Research Council Clinical Trials Centre were received from Cancer Australia and the Cancer Institute New South Wales for the AGITG MAX Trial.
Ethics approval: The AGITG MAX Trial has ethics approval and all patients were consented for the trial and any future analysis. The TRACC registry has IRB ethics approval for the registry and consent was not required for the registry. The South Western Sydney Local Health District Research and Ethics Board approved the “Low or negligible risk” ethics application for the two cancer centres in New South Wales and decided that consent was not required from the patients in the analysis; all patients were de-identified for the analysis.
Clinical trial registration: This study is registered at https://clinicaltrials.gov/show/NCT00294359; the registration identification number is NCT00294359.
Informed consent: All study participants in the AGITG MAX trial provided written informed consent prior to study enrolment.
Conflict-of-interest: All authors have disclosed an untied educational grant from Roche Products Pty Ltd (Australia). Roche has provided financial assistance for the development, installation and maintenance of the TRACC database.
Data sharing: No further data is available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Aflah Roohullah, MBChB, FRACP, Macarthur Cancer Therapy Centre, Campbelltown Hospital, Therry Road, Campbelltown NSW 2560, Australia. aflah.roohullah@sswahs.nsw.gov.au
Telephone: +61-2-46344355 Fax: +61-2-46344311
Received: December 18, 2014
Peer-review started: December 19, 2014
First decision: January 8, 2015
Revised: January 27, 2015
Accepted: March 12, 2015
Article in press: March 12, 2015
Published online: May 7, 2015
Processing time: 145 Days and 20.7 Hours
Core Tip

Core tip: This report is an analysis of three prospective studies including a randomized clinical trial. We analysed the rates of gastrointestinal perforation in patients with metastatic colorectal cancer and peritoneal disease receiving bevacizumab and systemic therapy. Previous reports had raised concerns regarding the risk of gastrointestinal perforation in this population. Our reports suggest that the absolute risk is not elevated and in addition clinicians appear to be confident in using bevacizumab in patients with colorectal cancer and peritoneal disease. We recommend that the presence of peritoneal disease is not a contraindication to the use of bevacizumab and systemic therapy.