Time toxicity of intravesical sequential gemcitabine and docetaxel.

Abstract

e23098 Background: While bacillus Calmette-Guérin (BCG) is the gold standard adjuvant therapy for high-risk non-muscle invasive bladder cancer (NMIBC) following transurethral resection of bladder tumor (TURBT), sequential intravesical gemcitabine and docetaxel (Gem/Doce) has rapidly been adopted as an effective treatment alternative. Utilization has grown during the BCG shortage and Gem/Doce is undergoing prospective evaluation. With intravesical therapy, there is patient “time toxicity” from instillation time, number of instillations, surveillance procedures, and management of side effects, which has not yet been measured or reported for Gem/Doce. Therefore, herein, we describe the time toxicity burden of Gem/Doce for patients with NMIBC. Methods: We queried our institution’s database of patients with NMIBC to identify patients treated with Gem/Doce between June 2022 and January 2025. Chart review was performed to identify the cumulative time patients spent in the health care system for TURBT, office appointments, Gem/Doce instillations, surveillance cystoscopies, and emergency room (ER) visits. TURBT time was calculated from the time the patient arrived to the preoperative area to discharge. ER visits were only included if the chief complaint was related to adverse events of Gem/Doce. Start and end times of encounters were estimated using available time stamps recorded in the electronic medical record. Results: There were 32 patients in this cohort. Median age was 76 years and 31% of patients were female. There were 50% of patients with T1 and 31% of patients with CIS disease. Fifteen (47%) patients had treatment naïve disease. The median time of TURBT was 369 minutes (IQR 346, 529). The median time of office visits was 87 minutes (IQR 68, 103). The median time for induction instillations was 221 minutes (IQR 189, 235), and the median instillation time for the first six monthly maintenance instillations was 193 minutes (IQR 168, 234). Twenty-three of thirty-two patients (72%) sought care at our institution’s ER during the time they were undergoing intravesical chemotherapy. The median time for these visits was 750 minutes (IQR 384, 1,621). One patient visited an ER at an outside hospital which took 397 minutes. Conclusions: To our knowledge, this is the first characterization of time toxicity for Gem/Doce. We found a moderate degree of patient burden as reflected by minutes spent during NMIBC care. Along with traditionally reported safety and efficacy metrics, this time analysis is important to validate and compare to other therapies in order to characterize and maximize quality of life.