SWOG S0353: Phase II Trial of Intravesical Gemcitabine in Patients with Non-Muscle Invasive Bladder Cancer Who Recurred Following at Least Two Prior Courses of Intravesical BCG.

Publication Type:

Journal Article


The Journal of urology (2013)


2013, May 2013, Public Health Sciences Division


PURPOSE: Prior phase II studies of intravesical gemcitabine have shown it to be active and well tolerated, but durable responses in patients with NMIBC who have recurred following BCG are uncommon. We performed a multi-institutional phase II study within the SWOG cooperative group to evaluate the potential role of gemcitabine induction plus maintenance therapy in this setting. MATERIALS AND METHODS: Eligible patients had recurrent NMIBC, stage Tis (CIS), T1, Ta high-grade (HG), or multifocal Ta low-grade, following at least 2 prior courses of BCG. Patients were treated with 2gm gemcitabine in 100cc NS intravesically weekly x6 and then monthly to 12 months. Cystoscopy and cytology were performed every 3 months, with biopsy at 3 months and then as clinically indicated. Initial complete response was defined as negative cystoscopy, cytology and biopsy at 3 months. RESULT5: 558 patients were enrolled; and 47 were evaluable for response. 42 (89%) of the evaluable patients had high-risk disease, HGTa in 12 (26%), HGT1 in 2 (4%), and CIS in 28 (60%) +/- papillary lesions. At the initial 3-month evaluation, 47% of patients were free of disease. At one year 28% of the 47 patients had not recurred, all except 2 from the high-risk group, and 21% at 2 years. CONCLUSION: Intravesical gemcitabine has activity in high risk NMIBC, and offers an option for patients who have recurred after BCG and are not suitable for cystectomy. However, less than 30% of patients had durable response at 12 months, even with maintenance therapy.