Intravesical gemcitabine as bladder‐preserving treatment for BCG unresponsive non‐muscle‐invasive bladder cancer. Results from a single‐arm, open‐label study

Abstract

Background There is an unmet alternative medical therapy for BCG unresponsive patients. Objective To report efficacy of intravesical gemcitabine in NMIBC patients, who failed a previous course of BCG, or intolerant, and unwilling to undergo radical cystectomy (RC). Material and methods This is an open‐label, single‐arm study, which enrolled patients showing a failure or were intolerant to BCG and unwilling to undergo the RC. Intravesical gemcitabine was administered once a week for six consecutive weeks and once a month for 12 months. The primary outcome was DFS defined as the lack of a tumor on cystoscopy and negative urine cytology. Secondary endpoint was safety defined according a grading of side effects. OS, PFS, and DFS were described with Kaplan–Meier method at 12 and 24 months. Results and limitations Overall 36 patients were enrolled. The median follow‐up was 27 months. The DFS was 68.75% at the end of induction phase and 44.44% and 31.66% at 12 and 24 months of, respectively. The PFS was 43.75%. The OS and CSS were 77.9% (95% CI 58.78%‐88.92%) and 80.68% (95% CI 61.49%‐90.96%), respectively. There was no life threatening event or treatment‐related death (grade 4 or 5). The most common mild and moderate adverse events reported were urinary symptoms (LUTS) and fatigue (G1‐G2). Conclusion Patients who presented an unresponsive‐BCG recurrent NMIBC and unwilling to receive a RC, could benefit from intravesical gemcitabine as salvage organ‐sparing treatment.

Attention to detail

“…I appreciate the efforts—I went “cold turkey” over a year ago in dropping routine drains and have no concerns with this change in practice. For further reading, see the systematic review by Kowalewski et al 2 , which looks at drain use across all urologic cancers and shows similar results. To the Clinic… The study by Hurle et al 3 looks at a not too uncommon clinical problem—the high‐grade non‐invasive bladder cancer patient with BCG unresponsive outcome. The gold standard is early cystectomy; however, in this series of 36 patients who refused cystectomy, a salvage treatment with intravesical gemcitabine yielded at 24‐month 32% disease‐specific survival, and without high‐grade toxicity.…”

“…To the Clinic… The study by Hurle et al 3 looks at a not too uncommon clinical problem—the high‐grade non‐invasive bladder cancer patient with BCG unresponsive outcome. The gold standard is early cystectomy; however, in this series of 36 patients who refused cystectomy, a salvage treatment with intravesical gemcitabine yielded at 24‐month 32% disease‐specific survival, and without high‐grade toxicity.…”

Manejo del cáncer de vejiga invasor de músculo con enfoque preservador de órgano: terapia trimodal

“…El cáncer de vejiga es una de las neoplasias más frecuentes del tracto urinario, con un estimado de 80.500 nuevos casos y 17.600 muertes durante el 2019 en los EE.UU. 1,2 . Es la novena malignidad más común en el mundo y la cuarta más común en hombres, con una relación hombre:mujer 3-4:1 [1][2][3] .…”

“…1,2 . Es la novena malignidad más común en el mundo y la cuarta más común en hombres, con una relación hombre:mujer 3-4:1 [1][2][3] .…”

“…Al diagnóstico, aproximadamente en el 25% de los pacientes con cáncer de vejiga estos se presentan como invasores de músculo 2 . Actualmente, la cistectomía radical (CR) en conjunto con la linfadenectomía pélvica extendida se consideran como la terapia estándar para el tratamiento del cáncer de vejiga invasor de músculo (MIBC, por sus siglas en inglés) 1,3,4 .…”