Introduction:

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.

Methods:

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.

Results:

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. Of note, at 3-month cystoscopy, 17/18 patients (94%) were visually free of recurrence. No patient progressed to muscle invasion during follow up. All patients started on gem/doce (n=18) completed induction without dose reduction or missed instillation due to adverse effects.

Conclusion:

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.

Funding: N/A