Journal of Clinical Oncology, Vol 5, 2004-2008, Copyright © 1987 by American Society of Clinical Oncology
Appropriate endpoints for superficial bladder cancer clinical trials
LA Kalish, MB Garnick and JP Richie
Division of Biostatistics, Dana-Farber Cancer Institute, Boston, MA 02115.
Many protocols for treatment of superficial bladder cancer include periodic
cystoscopic examinations with resection of visible lesions. This allows
pathological restaging of the disease at each examination. For example,
this type of follow-up is common in clinical trials evaluating intravesical
therapies. In such trials, clinical outcome is typically summarized using
end-points that measure failure to control superficial disease. Alternative
endpoints measuring failure to prevent progression to invasive disease are
often ignored. In this report, the rationale for ignoring the invasive
disease endpoints is given and flaws in the rationale are described.
Evidence from actual data sets support the view that superficial disease
endpoints may not be appropriate surrogates for invasive disease endpoints.
It is recommended that time to invasive disease should be considered a
major endpoint when designing and analyzing trials in superficial bladder
cancer.
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