Early Experience with Intravesical Gemcitabine-Docetaxel for BCG-Naïve Patients with High Grade Non-Muscle Invasive Bladder Cancer

Abstract

Intravesical BCG remains a first-line treatment for patients with intermediate/high risk non-muscle invasive bladder cancer (NMIBC) desiring bladder preservation. In the era of BCG shortage, alternative therapies such as sequential dual intravesical gemcitabine and docetaxel (gem/doce) have been described. We report short term outcomes of patients with BCG-Naïve NMIBC treated with gem/doce in lieu of BCG. Patients with high grade NMIBC who had not previously received BCG underwent visually complete TURBT followed by 6 weekly instillations of gemcitabine and docetaxel. At each instillation, patients received 1g of gemcitabine followed by 40mg of docetaxel each for 1-hour dwell. Primary outcome measure was 6-month cystoscopic response rate. Secondary outcome measures include 3-month cystoscopic response rate and progression to MIBC. 18 BCG-naïve subjects received intravesical gem/doce and completed follow up cystoscopy. Initial staging was Ta in 10, T1 in 4, and CIS in 4. At 6-month cystoscopy, 14/18 patients (78%) were visually free of recurrence. Of the 4 patients with CIS at initial staging, 3 (75%) were visually free of recurrence at 6-month cystoscopy and had benign urine cytology. On ensuing TURBT, there were 2 histologic recurrences. One patient had progression from CIS with Ta disease to CIS with T1 disease and one had persistent T1 disease. No patient progressed to muscle invasion during follow up. There were no further instances of tumor recurrence or progression between 3 and 6 months. All patients started on gem/doce (n=18) completed induction without dose reduction or missed instillation due to adverse effects. Sequential adjuvant gemcitabine/docetaxel intravesical therapy after TURBT shows promising 6-month response rates for BCG-naïve high grade NMIBC. Longer follow up is needed to assess durable response or effects on recurrence or progression.