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Appropriate endpoints for superficial bladder cancer clinical trials
L A Kalish1, M B Garnick, J P Richie
1Division of Biostatistics, Dana-Farber Cancer Institute, Boston, MA 02115.
Summary
Superficial bladder cancer trials often overlook invasive disease progression. This study argues that time to invasive disease is a critical endpoint, not just superficial disease control, for accurate treatment evaluation.
Area of Science:
- Urology
- Oncology
- Clinical Trials
Background:
- Superficial bladder cancer management involves regular cystoscopies and lesion resections.
- Clinical trials for intravesical therapies commonly assess superficial disease control.
- Endpoints focusing on invasive disease progression are frequently disregarded in these trials.
Purpose of the Study:
- To critically evaluate the rationale for ignoring invasive disease endpoints in superficial bladder cancer trials.
- To highlight the potential inadequacy of superficial disease endpoints as surrogates for invasive disease outcomes.
- To advocate for the inclusion of time to invasive disease as a primary endpoint in future research.
Main Methods:
- Review of existing protocols for superficial bladder cancer treatment and follow-up.
- Analysis of the rationale behind endpoint selection in clinical trials.
- Examination of data sets to compare superficial and invasive disease endpoints.
Main Results:
- The rationale for excluding invasive disease endpoints is flawed.
- Superficial disease endpoints may not accurately reflect or predict invasive disease progression.
- Data suggests a disconnect between controlling superficial disease and preventing invasion.
Conclusions:
- Time to invasive disease should be a major endpoint in superficial bladder cancer trials.
- Rethinking endpoint selection is crucial for accurate assessment of treatment efficacy.
- Prioritizing invasive disease endpoints will improve clinical trial design and analysis.