Annals of Oncology Advance Access originally published online on July 28, 2007
Annals of Oncology 2007 18(10):1666-1672; doi:10.1093/annonc/mdm267
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© 2007 European Society for Medical Oncology
gastrointestinal tumors |
Patient characteristics and stratification in medical treatment studies for metastatic colorectal cancer: A proposal for standardization of patient characteristic reporting and stratification
1 Department of Oncology, Haukeland University Hospital, Bergen, Norway
2 Klinik fur Innere Medizin, Oldenburg, Germany
3 Division of Biostatistics, Mayo Clinic Cancer Center, Mayo Clinic, Rochester, Minnesota, USA
4 Department of Oncology, Radiology and Clinical Immunology, Uppsala University, Uppsala, Sweden and Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden
* Correspondence to: Dr H. Sorbye, Department of Oncology, Haukeland University Hospital, 5021 Bergen, Norway. Tel: +44 1865 617058; Fax: +44 1865 617022, E-mail address: rowett.lewis{at}esmo.org
Background: Prognostic factors have the potential to determine the survival of patients to a greater extent than current antineoplastic agents. Despite this knowledge, there is no consensus on, first, what patient characteristics to report and, second, what stratification factors to use in metastatic colorectal cancer trials.
Patients and methods: Seven leading oncology and medical journals were reviewed for phase II and III publications reporting on medical treatment of metastatic colorectal cancer patients during 2001–2005. One hundred and forty-three studies with 21 214 patients were identified. The reporting of patient characteristics and use of stratification was noted.
Results: Age, gender, performance status, metastases location, sites and adjuvant chemotherapy were often reported (99–63%). Laboratory values as alkaline phosphatase, lactate dehydrogenase and white blood cell count, repeatedly found to be of prognostic relevance, were rarely reported (5–9%). Stratification was used in all phase III trials; however, only study centre was used with any consistency.
Conclusion: There is considerable inconsistency in the reporting of patient characteristics and use of stratification factors in metastatic colorectal cancer trials. We propose a standardization of patient characteristics reporting and stratification factors. A common set of characteristics and strata will aid in trial reporting, interpretation and future meta-analyses.
Key words: colorectal neoplasm, metastatic disease, patient characteristics, prognosis, stratification
Received for publication January 12, 2007. Revision received April 3, 2007. Accepted for publication April 30, 2007.
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