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
Image(s) (click to enlarge):
Early Experience with Intravesical Gemcitabine-Docetaxel for BCG-Naïve Patients with High Grade Non-Muscle Invasive Bladder Cancer
Category
Bladder Cancer > Non-Muscle Invasive Bladder Cancer
Description
Poster #43
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Presented By: Rilwan Babajide
Authors:
Rilwan Babajide
Craig Labbate
Ragheed Saoud
Piyush K. Agarwal