Is participation in a clinical trial associated with a survival benefit in patients with bladder cancer?
Bladder cancer that is unresponsive to intravesical therapies is difficult to treat. Patients with this disease usually have to try salvage therapies, partial cystectomy, or radical cystectomy. Unfortunately, the population afflicted by bladder cancer is older and frailer than those afflicted by other cancers with mortality approaching 1.5% and readmission rates approaching 64%. These patients are left with no other options aside from participating in a clinical trial to delay or avoid surgery. We hypothesized that participation in a clinical trial provides survival benefits when controlling for tumor stage and pathology in the case of non-muscle invasive bladder cancer that is refractory to intravesical Bacillus Calmette-Guérin (BCG). Using our Institutional Review Board (IRB) approved Columbia Urologic Oncology Database, 55 patients with BCG-refractory NMIBC (29 clinical trial patients, 26 non-clinical trial patients) were identified between 2008 and 2012. Clinical characteristics, demographics, and outcomes were obtained from the medical records. Non-clinical trial patients had fewer mean BCG instillations than their clinical trial counterparts (7.8 versus 11.5 doses, p < .01). Kaplan Meier (KP) curves for Overall Survival (OS) and Cancer Specific Survival (CSS) indicate an increased survival benefit for patients enrolled in a clinical trial (OS: χ2 = 8.802, p< 0.01, median of 6.68 years versus 3.15 years; CSS: χ2 = 10.205, p < 0.01, mean 5.6 years versus 2.65 years). The data support the notion that there may be an inherent survival benefit gained by virtue of being included in a clinical trial. The drivers of this survival benefit may include more interactions with the hospitals and clinics, greater patient involvement in their health care, and increased surveillance by clinicians.
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- Columbia Medical Review
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- Academic Units
- College of Physicians and Surgeons
- Columbia University
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- August 25, 2015