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Annals of Oncology Advance Access published online on July 24, 2009
Annals of Oncology, doi:10.1093/annonc/mdp330
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

A prospective monitoring of fatal serious adverse events (SAEs) in a Dutch Colorectal Cancer Group (DCCG) phase III trial (CAIRO) in patients with advanced colorectal cancer

L. Mol1, M. Koopman2, P. B. Ottevanger2 and C. J. A. Punt2,*

1 Trails Office, Comprehensive Cancer Centre East (IKO), Nijmegen
2 Department of Medical Oncology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands

* Correspondence to: Dr C. J. A. Punt, Department of Medical Oncology, Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB Nijmegen, The Netherlands; Tel: +31-24-3610353; Fax: +31-24-3540788; E-mail: C.Punt{at}onco.umcn.nl

Background: Early and correct assessment of treatment-related mortality is highly important in clinical cancer trials. However, no data are available on the quality of safety monitoring.

Patients and methods: An on-site review was carried out by the study coordinators of the individual charts of all patients participating in the Capecitabine-Irinotecan-Oxaliplatin (CAIRO) study who had died within 30 days of the last administration of study drugs when death was accompanied by any other event than disease progression. The relationship between treatment and death was categorized as unrelated, remote, possible, or probable and submitted to an independent data monitoring committee (IDMC). These results were then compared with the initial assessment of the local investigator.

Results: Forty of 820 patients qualified for review. The relationship between cause of death and study drugs was changed in 26 patients (65%). A major protocol violation (MPV) was identified in 12 of 14 patients with a probable relationship between cause of death and study treatment.

Conclusions: There was little agreement between the relation as assessed by the local investigator compared with the IDMC. A quality control improves the assessment of safety results and the observed MPVs underscore the importance of educating medical staff and patients.

colorectal cancer, data management, monitoring, protocol violations, serious adverse events

Received for publication February 26, 2009. Revision received May 12, 2009. Accepted for publication May 14, 2009.


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