Safety, Tolerability, and Preliminary Efficacy of TAR-200 in Patients with Muscle-invasive Bladder Cancer Who Refused or Were Unfit for Curative-intent Therapy : A Phase 1 Study
Tyson, Mark D. (Mayo Clinic Arizona (Phoenix, Estats Units d'Amèrica))
Morris, David (Urology Associates)
Palou, Juan (Institut d'Investigació Biomèdica Sant Pau)
Rodriguez, Oscar (Institut d'Investigació Biomèdica Sant Pau)
Mir, Maria Carmen (Fundacion Instituto Valenciano de Oncologia)
Dickstein, Rian J. (Chesapeake Urology)
Guerrero-Ramos, Félix (Hospital Universitario 12 de Octubre (Madrid))
Scarpato, Kristen R. (Vanderbilt University Medical Center)
Hafron, Jason M. (Michigan Institute of Urology)
Messing, Edward M. (University of Rochester)
Cutie, Christopher J. (Janssen Research and Development)
Maffeo, John C. (Janssen Research and Development)
Raybold, Bradley (Janssen Research and Development)
Chau, Albert (Datacision Limited)
Stromberg, Katharine A. (Janssen Research and Development)
Keegan, Kirk A. (Janssen Research and Development)
Universitat Autònoma de Barcelona

Data:	2023
Resum:	Half of patients with muscle-invasive bladder cancer worldwide may not receive curative-intent therapy. Elderly or frail patients are most affected by this unmet need. TAR-200 is a novel, intravesical drug delivery system that provides sustained, local release of gemcitabine into the bladder over a 21-day dosing cycle. The phase 1 TAR-200-103 study evaluated the safety, tolerability, and preliminary efficacy of TAR-200 in patients with muscle-invasive bladder cancer who either refused or were unfit for curative-intent therapy. Materials and Eligible patients had cT2-cT3bN0M0 urothelial carcinoma of the bladder. TAR-200 was inserted for 4 consecutive 21-day cycles over 84 days. The primary end points were safety and tolerability at 84 days. Secondary end points included rates of clinical complete response and partial response as determined by cystoscopy, biopsy, and imaging; duration of response; and overall survival. Median age of the 35 enrolled patients was 84 years, and most were male (24/35, 68. 6%). Treatment-emergent adverse events related to TAR-200 occurred in 15 patients. Two patients experienced treatment-emergent adverse events leading to removal of TAR-200. At 3 months, complete response and partial response rates were 31. 4% (11/35) and 8. 6% (3/35), respectively, yielding an overall response rate of 40. 0% (14/35; 95% CI 23. 9-57. 9). Median overall survival and duration of response were 27. 3 months (95% CI 10. 1-not estimable) and 14 months (95% CI 10. 6-22. 7), respectively. Progression-free rate at 12 months was 70. 5%. TAR-200 was generally safe, well tolerated, and had beneficial preliminary efficacy in this elderly and frail cohort with limited treatment options.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Administration ; Intravesical ; Gemcitabine ; Urinary bladder neoplasms
Publicat a:	Journal of Urology, Vol. 209 Núm. 5 (january 2023) , p. 890-900, ISSN 1527-3792

DOI: 10.1097/JU.0000000000003195
PMID: 37026631

11 p, 609.7 KB

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