Intravesical Gemcitabine and Docetaxel in Patients with Recurrent High-Grade NMIBC - Expert Commentary
This single-arm, prospective, observational study included 39 patients with recurrent high-grade NMIBC who received intravesical gem/doce. Most patients (79%, 31/39) had carcinoma in situ (CIS). Gem/doce was administered as third-line treatment in 87% (34/39) of cases. The treatment regimen consisted of 6 weekly instillations (induction) followed by monthly maintenance instillations for 1 year. Each instillation began with gemcitabine (1 gram in 50 ml sterile water) retained for 1 hour, followed by docetaxel (37.5 mg in 50 ml saline) for another hour. Follow-up cystoscopies were performed every 3 months, with histological confirmation required for recurrences. The primary outcome was high-grade disease-free survival, defined as time to histologically confirmed high-grade recurrence and/or radiologically confirmed progression.
Among the 37 patients evaluated for efficacy, the median follow-up for those without high-grade recurrence was 14 months (IQR: 7-25). The overall 1-year high-grade disease-free survival was 67% (95% CI: 53-85), and 73% (57-94) in patients with BCG-unresponsive NMIBC. For patients with BCG-unresponsive CIS, the 1-year high-grade disease-free survival rate was 69% (95% CI: 49-96). Of the patients experiencing recurrence, 48% had CIS only. Adverse events were reported in 77% (30/39) of patients, with bladder spasm (46%) and urinary pain (33%) being most common. Only one serious adverse event occurred (grade 3 pyelonephritis requiring hospitalization). Three patients (7.7%) discontinued treatment due to side effects.
This important study demonstrated that intravesical gem/doce is an effective and well-tolerated treatment option for heavily pretreated patients with recurrent high-grade NMIBC. The findings of this study support the emerging role of gem/doce as a bladder-sparing approach for patients in whom BCG has failed. Randomized trials of this regimen are currently ongoing.
Written by: Bishoy M. Faltas, MD, Chief Research Officer, Englander Institute for Precision Medicine, Gellert Family - John P. Leonard, MD, Research Scholar, Associate Professor of Medicine, Cell and Developmental Biology, Weill Cornell Medicine, New York- Presbyterian Hospital, NY
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