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Journal of the National Cancer Institute Advance Access originally published online on June 27, 2007
JNCI Journal of the National Cancer Institute 2007 99(13):998-1003; doi:10.1093/jnci/djm024
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© 2007 The Author(s).
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/2.0/uk/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

COMMENTARY

Endpoints in Adjuvant Treatment Trials: A Systematic Review of the Literature in Colon Cancer and Proposed Definitions for Future Trials

Cornelis J. A. Punt, Marc Buyse, Claus-Henning Köhne, Peter Hohenberger, Roberto Labianca, Hans J. Schmoll, Lars Påhlman, Alberto Sobrero, Jean-Yves Douillard

Affiliations of authors: Department of Medical Oncology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands (CJAP); International Drug Development Institute, Louvain-la-Neuve, Belgium (MB); Clinic for Oncology and Hematology, Oldenburg Clinic, Oldenburg, Germany (CHK); Division of Surgical Oncology and Thoracic Surgery, Department of Surgery, Medical Faculty of Mannheim, University of Heidelberg, Heidelberg, Germany (PH); Unit of Medical Oncology, Riuniti Hospital, Bergamo, Italy (RL); Department of Hematology and Oncology, Martin Luther University, Halle, Germany (HJS); Department of Surgery, University Hospital, SE 751 85 Uppsala, Sweden (LP); Department of Medical Oncology, S. Martino Hospital, Genova, Italy (AS); Center R. Gauducheau 44805 Nantes-St Herblain, France (JYD)

Correspondence to: Cornelis J. A. Punt, MD, PhD, Department of Medical Oncology Radboud University Nijmegen Medical Center, PO Box 9101 6500 HB Nijmegen, The Netherlands (e-mail: c.punt{at}onco.umcn.nl).

Disease-free survival is increasingly being used as the primary endpoint of most trials testing adjuvant treatments in cancer. Other frequently used endpoints include overall survival, recurrence-free survival, and time to recurrence. These endpoints are often defined differently in different trials in the same type of cancer, leading to a lack of comparability among trials. In this Commentary, we used adjuvant studies in colon cancer as a model to address this issue. In a systematic review of the literature, we identified 52 studies of adjuvant treatment in colon cancer published in 1997–2006 that used eight other endpoints in addition to overall survival. Both the definition of these endpoints and the starting point for measuring time to the events that constituted these endpoints varied widely. A panel of experts on clinical research on colorectal cancer then reached consensus on the definition of each endpoint. Disease-free survival—defined as the time from randomization to any event, irrespective of cause—was considered to be the most informative endpoint for assessing the effect of treatment and therefore the most relevant to clinical practice. The proposed guidelines may add to the quality and cross-comparability of future studies of adjuvant treatments for cancer.

Manuscript received January 16, 2007; revised April 23, 2007; accepted May 22, 2007.


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