Bacillus Calmette-Guerin (BCG) is the standard of care for high-risk nonmuscle invasive bladder cancer (NMIBC), but half of patients develop disease recurrence. Intravesical regimens for BCG unresponsive NMIBC are limited. We report the safety, efficacy, and differential response of sequential gemcitabine/docetaxel (gem/doce) depending on BCG failure classification.
Multi-institutional retrospective analysis of patients treated with induction intravesical gem/doce (≥5/6 instillations) for recurrent high-risk NMIBC after BCG therapy from May 2018 to December 2021. Maintenance therapy was provided to those without high-grade (HG) recurrence on surveillance cystoscopy. Kaplan-Meier curves and Cox regression analyses were utilized to assess survival and risk factors for disease recurrence.
Our cohort included 102 patients with BCG-unresponsive NMIBC. Median age was 72 years and median follow-up was 18 months. Six-, 12-, and 24-month high-grade recurrence-free survival was 78%, 65%, and 49%, respectively. Twenty patients underwent radical cystectomy (median 15.5 months from induction). Six patients progressed to muscle invasive disease. Fifty-seven percent of patients experienced mild/moderate adverse effects (AE), but only 6.9% experienced a delay in treatment schedule. Most common AE were urinary frequency/urgency (41%) and dysuria (21%). Patients with BCG refractory disease were more likely to develop HG recurrence when compared to patients with BCG relapsing disease (HR 2.14; 95% CI 1.02-4.49).
In patients with recurrence after BCG therapy, sequential intravesical gem/doce is an effective and well-tolerated alternative to early cystectomy. Patients with BCG relapsing disease are more likely to respond to additional intravesical gem/doce. Further investigation with a prospective trial is imperative.
Urologic oncology. 2023 Sep 08 [Epub ahead of print]
Kendrick Yim, Kevin Melnick, Sarah L Mott, Filipe L F Carvalho, Affan Zafar, Timothy N Clinton, Matthew Mossanen, Graeme S Steele, Michelle Hirsch, Natalie Rizzo, Chin-Lee Wu, Kent W Mouw, Matthew Wszolek, Keyan Salari, Adam Feldman, Adam S Kibel, Michael A O'Donnell, Mark A Preston
Division of Urology, Brigham and Women's Hospital, Boston, MA., Department of Urology, University of Iowa, Iowa City, IA., Department of Pathology, Brigham and Women's Hospital, Boston MA., Department of Pathology, Massachusetts General Hospital, Boston, MA., Department of Radiation Oncology, Dana Farber Cancer Institute, Boston, MA., Department of Urology, Massachusetts General Hospital, Boston, MA., Division of Urology, Brigham and Women's Hospital, Boston, MA. Electronic address: .