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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.
story of the week
Theranostic Targeting of CDCP1 in Multiple Subtypes of Bladder Cancer
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