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Long-Term Follow-Up of Sequential Intravesical Gemcitabine and Docetaxel Salvage Therapy for NMIBC
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Intravesical gemcitabine and docetaxel (Gem/Doce) has been established as a safe and efficacious salvage treatment for recurrent NMIBC since 2015. Despite widespread adoption of this regimen, long-term outcomes have not been described. We report our experience with intravesical Gem/Doce following BCG failure in a large cohort of patients with extended follow-up.
We retrospectively identified 97 patients at our institution treated with Gem/Doce for high-risk NMIBC after BCG failure between 2009 and 2017. Patients received six weekly intravesical Gem/Doce instillations. Monthly maintenance for 2 years was initiated if disease free at first follow-up. Outcomes included recurrence-free survival (RFS), high-grade recurrence-free survival (HG-RFS), progression-free survival (PFS), cystectomy-free survival (CFS), cancer-specific survival (CSS), and overall survival (OS). Survival probabilities were estimated using the Kaplan-Meier method.
Median follow-up was 49 months. Median age was 73 years, and 71% of the cohort had CIS containing disease. Thirty five percent of the cohort had BCG-unresponsive disease. Complete response at 3-month surveillance was 74% and median duration of response was 25 months. At 1, 2, and 5 years, HG-RFS was 60%, 50%, and 30%, respectively. HG-RFS was similar among BCG-unresponsive patients and the overall cohort. During follow-up, 20 patients underwent cystectomy and 15 patients experienced disease progression. Five-year PFS, CFS, CSS, and OS were 82%, 75%, 91%, and 64%, respectively.
In this long-term analysis, intravesical Gem/Doce for high-risk NMIBC after BCG failure yielded a 75% 5-year bladder preservation rate and a 91% 5-year cancer-specific survival rate. Further prospective trials are warranted.
Disclosure statements are available on the authors' profiles:
Long-term follow-up of sequential intravesical gemcitabine and docetaxel salvage therapy for non-muscle invasive bladder cancerUrol. Oncol 2022 Nov 28;[EPub Ahead of Print], PT Chevuru, IM McElree, SL Mott, RL Steinberg, MA O'Donnell, VT Packiam
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
Although the advent of alternative intravesical therapies such as nadofaragene firadenovec1 and the recent approval of intravenous pembrolizumab2 for BCG-unresponsive disease has expanded the available treatment options for patients, the management of high-risk non–muscle-invasive bladder cancer after BCG failure remains complex. This article provides key data regarding the long-term efficacy of intravesical gemcitabine/docetaxel in a heterogenous group of patients experiencing BCG failure and seeking bladder preservation. In this study, the authors report high rates of 5-year cystectomy-free and progression-free survival of 75% and 82%, respectively. These results promote bladder preservation with gemcitabine/docetaxel as an attractive second-line modality in the armamentarium of urologists treating BCG-unresponsive disease.
1. Boorjian SA, Alemozaffar M, Konety BR, et al. Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, open-label, repeat-dose clinical trial. Lancet Oncol. 2021;22(1):107-117. https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(20)30540-4/fulltext
2. Balar AV, Kamat AM, Kulkarni GS, et al. Pembrolizumab monotherapy for the treatment of high-risk non-muscle-invasive bladder cancer unresponsive to BCG (KEYNOTE-057): an open-label, single-arm, multicentre, phase 2 study. Lancet Oncol. 2021;22(7):919-930. Erratum in: Lancet Oncol. 2021;22(8):e347. https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00147-9/fulltext