The significance of protocol biopsy after intravesical BCG treatment in patients with non-muscle–invasive bladder cancer.

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356 Background: Currently, there are few well-validated data of the optimal schedule of follow-up after BCG intravesical instillation. The objective of the study were to elucidate the ability of conventional exams (cystoscopy, urine cytology) to diagnose presence of carcinoma and the significance of protocol biopsy after BCG intravesical treatment in patients with high-risk non-muscle-invasive bladder cancer (NMIBC). Methods: The study included patients treated with BCG intravesical treatment. From January 2002 to October 2012, we retrospectively reviewed a total of 72 patients (61 men and 11 women). The median age was 72 years (range 47-84). The pathological stages were Tis in 4 patients (6%), Ta in 29 (40%) and T1 in 39 (54%) (T1 with CIS in 30 [42%]). Tumors were multifocal in 56 (78%) and second TUR had been performed in 53 (74%) patients. We investigated the prognosis and accuracy of tumor existence by conventional exams referring with the protocol biopsy. A protocol biopsy was performed within 5 to 9 months after the final TUR. CTCAE v4.0 was used to grade adverse events. Results: Of 72 patients, we performed protocol biopsy in 62 patients and 9 (15%) had cancer. The conventional methods had a sensitivity of 78%, specificity of 81%, positive predictive value of 41% and negative predictive value of 96% in diagnosing cancer. Although three (5%) had grade2 adverse events, there were no grade 3 or greater adverse events. Of 53 patients with no cancer in protocol biopsy, 8 (8%) patients experienced a recurrence but 51patients (96%) were alive with no evidence of disease. Of 9 patients pointed out cancer in protocol biopsy, 7patients (78%) had no evidence of disease recurrence at last follow-up. The 5-year recurrence-free survival rate and overall survival rate were 77% and 95%, respectively. Conclusions: To the best of our knowledge, this is the first report of the ability of conventional exams for follow-up after BCG treatment. Our findings revealed that conventional exams were limited for meticulous follow-up, so that the protocol biopsy will be recommended to obtain the better survival in high-risk NMIBC patients.