A Phase I Trial of Intravesical Cabazitaxel, Gemcitabine and Cisplatin for the Treatment of Nonmuscle Invasive bacillus Calmette-Guérin Unresponsive or Recurrent/Relapsing Urothelial Carcinoma of the Bladder
| Autor: | Charles G. Drake, Cory Abate-Shen, Guarionex Joel DeCastro, Max M. Kates, Renu K. Virk, Christopher B. Anderson, Bridget James, Wilson Sui, Dara Holder, Jamie S. Pak, Shing M. Lee, James M. McKiernan |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Male Urology 030232 urology & nephrology Deoxycytidine 03 medical and health sciences 0302 clinical medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Urothelial carcinoma Aged Cisplatin Bacillus (shape) Aged 80 and over Carcinoma Transitional Cell Bladder cancer biology Dose-Response Relationship Drug business.industry Middle Aged biology.organism_classification medicine.disease Gemcitabine Administration Intravesical Urinary Bladder Neoplasms Cabazitaxel Cancer research BCG Vaccine Female Taxoids Neoplasm Recurrence Local business medicine.drug |
| Zdroj: | The Journal of urology. 204(2) |
| ISSN: | 1527-3792 |
| Popis: | For patients with bacillus Calmette-Guérin unresponsive or recurrent/relapsing nonmuscle invasive bladder cancer, multi-agent intravesical trials have been limited. In this study we investigate the safety of intravesical cabazitaxel, gemcitabine and cisplatin in the salvage setting.This was a dose escalation, drug escalation trial for patients with bacillus Calmette-Guérin unresponsive or recurrent/relapsing nonmuscle invasive bladder cancer who declined or were ineligible for radical cystectomy. All patients underwent a 6-week induction regimen of sequentially administered cabazitaxel, gemcitabine and cisplatin. Complete response was defined as no cancer on post-induction transurethral bladder tumor resection and negative urine cytology, while partial response allowed for positive cytology. Responders continued with maintenance cabazitaxel and gemcitabine monthly for the first year and bimonthly for the second year.A total of 18 patients were enrolled. Mean age was 71 years, median followup was 27.8 months (range 16.3 to 46.9) and mean number of previous rounds of intravesical therapies before trial enrollment was 3.7. Nine patients (50%) had received intravesical chemotherapy after bacillus Calmette-Guérin and 7 (39%) were previously treated in a phase I clinical trial setting. At enrollment 6 (33%) subjects had T1 disease and 13 (72%) had carcinoma in situ. There were no dose limiting toxicities. Initial partial and complete response rates were 94% and 89%, respectively. At 1 year recurrence-free survival was 0.83 (range 0.57 to 0.94) and at 2 years estimated recurrence-free survival was 0.64 (0.32 to 0.84).In this high risk and highly pretreated cohort of bacillus Calmette-Guérin unresponsive or recurrent/relapsing nonmuscle invasive bladder cancer cases combination intravesical cabazitaxel, gemcitabine and cisplatin was a well tolerated and potentially effective regimen. |
| Databáze: | OpenAIRE |
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