Urology · 2008
Impact of previous bacille Calmette-Guérin failure pattern on subsequent response to bacille Calmette-Guérin plus interferon intravesical therapy.
Клиническое исследование II фазыСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Gallagher Brian L, Joudi Fadi N, Maymí José L, O'Donnell Michael A
Аннотация
OBJECTIVES: To evaluate the effect of the bacille Calmette-Guérin (BCG) failure pattern in patients with non-muscle-invasive bladder cancer on the subsequent response to intravesical immunotherapy.
METHODS: Data from the national Phase II multicenter trial for BCG plus interferon-alpha intravesical therapy for non-muscle-invasive bladder cancer were analyzed. The cancer-free rates for BCG-naive (BCG-N) and BCG-failure (BCG-F) patients with different failure patterns were compared using Kaplan-Meier analysis.
RESULTS: At a median follow-up of 24 months, the BCG-N and BCG-F patients had a cancer-free rate of 59% and 45%, respectively. The BCG-F patients with immediate recurrence (refractory disease), within 6, 6 to 12, 12 to 24, and longer than 24 months had a cancer-free rate of 34%, 41%, 43%, 53%, and 66%, respectively (P = 0.005 for trend). No statistically significant difference was found in the cancer-free rates between patients with failure after 12 months and those with failure after 24 months or between BCG-N patients and those with failure after 12 and 24 months. A multivariate analysis of patients with failure after 12 months revealed that the number of previous courses of BCG did not significantly affect the treatment response.
CONCLUSIONS: Patients with non-muscle-invasive bladder cancer with disease recurrence more than 1 year after BCG treatment and who were treated with low-dose BCG plus interferon-alpha had response rates similar to those of BCG-N patients treated with regular-dose BCG plus interferon. Although cystectomy should still be strongly considered, these patients might benefit from another trial with intravesical immunotherapy. In contrast, recurrence within 1 year of BCG treatment should lead to consideration of either cystectomy or alternative intravesical therapies.
METHODS: Data from the national Phase II multicenter trial for BCG plus interferon-alpha intravesical therapy for non-muscle-invasive bladder cancer were analyzed. The cancer-free rates for BCG-naive (BCG-N) and BCG-failure (BCG-F) patients with different failure patterns were compared using Kaplan-Meier analysis.
RESULTS: At a median follow-up of 24 months, the BCG-N and BCG-F patients had a cancer-free rate of 59% and 45%, respectively. The BCG-F patients with immediate recurrence (refractory disease), within 6, 6 to 12, 12 to 24, and longer than 24 months had a cancer-free rate of 34%, 41%, 43%, 53%, and 66%, respectively (P = 0.005 for trend). No statistically significant difference was found in the cancer-free rates between patients with failure after 12 months and those with failure after 24 months or between BCG-N patients and those with failure after 12 and 24 months. A multivariate analysis of patients with failure after 12 months revealed that the number of previous courses of BCG did not significantly affect the treatment response.
CONCLUSIONS: Patients with non-muscle-invasive bladder cancer with disease recurrence more than 1 year after BCG treatment and who were treated with low-dose BCG plus interferon-alpha had response rates similar to those of BCG-N patients treated with regular-dose BCG plus interferon. Although cystectomy should still be strongly considered, these patients might benefit from another trial with intravesical immunotherapy. In contrast, recurrence within 1 year of BCG treatment should lead to consideration of either cystectomy or alternative intravesical therapies.