Journal article
Sequential Intravesical Gemcitabine and Docetaxel for bacillus Calmette-Guerin-Naive High-Risk Nonmuscle-Invasive Bladder Cancer
The Journal of urology, Vol.208(3), pp.589-597
09/01/2022
DOI: 10.1097/JU.0000000000002740
PMID: 35892270
Abstract
Purpose: Bacillus Calmette-Guerin (BCG) is currently recommended as adjuvant therapy following complete transurethral resection of bladder tumor for high-risk nonmuscle-invasive bladder cancer (NMIBC). In response to the BCG shortage, gemcitabine plus docetaxel (Gem/Doce) has been utilized at our institution in the BCG-naive setting. We report the outcomes of patients with high-risk BCG-naive NMIBC treated with Gem/Doce.
Materials and Methods: We retrospectively reviewed patients with BCG-naive high-risk NMIBC treated with Gem/Doce from May 2013 through April 2021. Patients received 6 weekly intravesical instillations of sequential 1 gm gemcitabine and 37.5 mg docetaxel after complete transurethral resection of bladder tumor. Monthly maintenance of 2 years was initiated if disease-free at first follow-up. The primary outcome was recurrence-free survival. Survival was assessed with the Kaplan-Meier method, indexed from the first Gem/Doce instillation. Adverse events were reported using CTCAE (Common Terminology Criteria for Adverse Events) v5 (National Cancer Institute, Bethesda, Maryland). Differences were assessed with the log-rank test.
Results: There were 107 patients with a median followup of 15 months included in the analysis. Patients had high-risk characteristics including 47 with any carcinoma in situ and 55 with T1 disease. Recurrence-free survival was 89%, 85% and 82% at 6, 12 and 24 months, respectively. Recurrence rates were similar between patients with or without carcinoma in situ (p=0.42). No patient had disease progression or died of bladder cancer. One patient underwent cystectomy due to end-stage lower urinary tract symptoms. Overall survival was 84% at 24 months. There were 92 adverse events (1 >= grade 3), and 4 (4%) patients were unable to receive a full induction course.
Conclusions: Gem/Doce is an effective and well-tolerated therapy for BCG-naive NMIBC. Further investigation is warranted.
Details
- Title: Subtitle
- Sequential Intravesical Gemcitabine and Docetaxel for bacillus Calmette-Guerin-Naive High-Risk Nonmuscle-Invasive Bladder Cancer
- Creators
- Ian M. McElree - Roy J. and Lucille A. Carver College of MedicineRyan L. Steinberg - University of IowaAlex C. Martin - University of IowaJordan Richards - University of IowaSarah L. Mott - University of IowaPaul T. Gellhaus - University of IowaKenneth G. Nepple - University of IowaMichael A. O'Donnell - University of IowaVignesh T. Packiam - University of Iowa
- Resource Type
- Journal article
- Publication Details
- The Journal of urology, Vol.208(3), pp.589-597
- Publisher
- Lippincott Williams & Wilkins
- DOI
- 10.1097/JU.0000000000002740
- PMID
- 35892270
- ISSN
- 0022-5347
- eISSN
- 1527-3792
- Number of pages
- 9
- Grant note
- Carver College of Medicine John & Carol Walter Family Foundation
- Language
- English
- Date published
- 09/01/2022
- Academic Unit
- Urology
- Record Identifier
- 9984320072902771
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