© The Author 2006. Published by Oxford University Press.
EDITORIAL |
On the Toxicity of Chemotherapy for Breast Cancer—the Need for Vigilance
Affiliations of authors: Division of Hematology-Oncology (JKE) and Institute for Clinical Research and Health Policy Studies (JL), Tufts-New England Medical Center, Boston, MA
Correspondence to: Joseph Lau, MD, Institute for Clinical Research and Health Policy Studies, Tufts-New England Medical Center, 750 Washington Street, Box 63, Boston, MA 02111 (e-mail: JLau1@tufts-nemc.org).
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Primum non nocere, "First, do no harm" is a central tenet guiding medical practice. To know whether a prescribed treatment may cause harm and to assess that quality that has been referred to by the National Surgical Adjuvant Breast and Bowel Project and others as the "worth" of a treatment, clinicians depend on well-designed clinical trials. The function of such trials should be to estimate worth by carefully weighing the difference between the potential benefit and the potential harm of a treatment. However, clinical trials in cancer are usually powered to assess endpoints such as disease-free and overall survival, rather than the toxicities of interventions. Thus, trial design often precludes precise quantification of infrequent toxicities. Furthermore, even in well-designed trials, toxicity reporting is often incomplete, uncertain, or truncated at the
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