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February 16, 2005

Trends in the Risks and Benefits to Patients With Cancer in Phase 1 Clinical Trials

Author Affiliations

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2005;293(7):795. doi:10.1001/jama.293.7.795-a

To the Editor: The study of trends in risks and benefits to patients with cancer in phase 1 clinical trials by Dr Roberts and colleagues1 was noted to be the first analysis of phase 1 cancer trials in the era of targeted therapy. As such, I would be interested to know why an analysis of the response category of stable disease was not included, since targeted therapies for solid tumors are often thought to be cytostatic rather than cytotoxic in their mechanisms of action. If targeted therapies predominate in recent studies, the finding of a decrease in the frequency of complete and partial response over time is no surprise, but I would also expect determinations of stable disease to increase. I would also like to know time trends in the use of tumor markers or other measures of target effects that, in contrast to maximum tolerated dose, can be used for dosing decisions.

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