RESULTSIn all, 276 patients met the inclusion criteria (174 RN and 102 PN) of whom 209 had a preoperative eGFR of > 60 mL/min/1.73m 2 . After ≥ 3 months from surgery, 108/209 (52%) patients developed new-onset eGFR of < 60 mL/min/1.73m 2 . On multivariate analysis, preoperative CKD stage ( P < 0.001) and procedure ( P = 0.001) were both independent predictors of all four functional outcomes measured. Also, hypertension was an independent predictor of CKD upstaging ( P = 0.02). Surgical access technique was not an independent predictor of any of the renal functional outcomes measured.
CONCLUSIONPatients undergoing renal surgery have a high rate of new-onset CKD afterward. After controlling for preoperative risk factors, patients undergoing RN are at greater risk of a decline in renal function. However, surgical access technique was not a significant predictor for renal impairment.
Intravesical nanoparticle albumin-bound paclitaxel exhibited minimal toxicity and systemic absorption in the first human intravesical phase I trial to our knowledge. A larger phase II study has begun to formally evaluate the activity of this regimen.
OBJECTIVES
To report the long-term clinical outcomes and durability of response after treatment with induction intravesical docetaxel. Most novel agents used to treat bacillus Calmette-Guerin refractory high-grade non–muscle-invasive (NMI) bladder cancer are evaluated only after short follow-up periods. Our previously published phase I trial demonstrated that docetaxel is a safe agent for intravesical therapy with minimal toxicity and no detectable systemic absorption. We sought to determine long-term clinical outcomes after treatment with intravesical docetaxel.
METHODS
Eighteen patients with recurrent Ta (n = 7), T1 (n = 5), and Tis (n = 6) transitional cell carcinoma who experienced treatment failure with at least 1 prior intravesical therapy completed the phase I trial. Docetaxel was administered as 6 weekly intravesical instillations using a dose-escalation model terminated at 0.75 mg/mL. Efficacy was evaluated by interval cystoscopy with biopsies when indicated, cytology, and computed tomography imaging. Follow-up consisted of quarterly cystoscopy, cytology, computed tomography, and biopsy when indicated.
RESULTS
With a median follow-up of 48.3 months, 4 patients (22%) have demonstrated a complete durable response and currently remain disease-free without further treatment. Three patients (17%) had a partial response, defined as a single NMI recurrence with no further therapy for bladder cancer. Eleven patients (61%) failed treatment, and required another intervention. One patient developed stage progression. No delayed toxicities were noted. The median disease-free survival time was 13.3 months.
CONCLUSIONS
After 4 years of follow-up without maintenance therapy, intravesical docetaxel has demonstrated the ability to prevent recurrence in a select number of patients with refractory NMI bladder cancer and warrants further investigation.
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