| Autor: |
F. Johannes P. van Valenberg, Antoine G. van der Heijden, Christopher J. Cutie, Sumeet Bhanvadia, Kirk A. Keegan, Shalaka Hampras, Hussein Sweiti, John C. Maffeo, Shu Jin, Albert Chau, Donald L. Reynolds, Crysti Iarossi, April Kelley, Xiang Li, Katharine A. Stromberg, J.P. Michiel Sedelaar, Jessica J.O. Steenbruggen, Diederik M. Somford, J. Alfred Witjes |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
|
| Zdroj: |
European Urology Open Science, Vol 62, Iss , Pp 8-15 (2024) |
| Druh dokumentu: |
article |
| ISSN: |
2666-1683 |
| DOI: |
10.1016/j.euros.2024.01.013 |
| Popis: |
Background and objective: Patients with intermediate-risk non–muscle-invasive bladder cancer (IR NMIBC) have a high risk of recurrence and need effective therapies to reduce the risk of disease recurrence or progression. This phase 1b study (NCT02720367) assessed the safety and tolerability of TAR-200, an intravesical drug delivery system, in participants with IR NMIBC. Methods: Participants with recurrent IR NMIBC were eligible. Participants received either two 7-d or two 21-d TAR-200 dosing cycles over a 4–6-wk period in a marker lesion/ablation design. TAR-200 was placed in the window between the cystoscopy showing recurrent papillary disease and the subsequent complete transurethral resection of the bladder tumour. The primary endpoint was TAR-200 safety. The secondary endpoints included TAR-200 tolerability, pharmacokinetics, and preliminary efficacy. Key findings and limitations: Twelve participants received TAR-200 treatment. No TAR-200–related serious or grade ≥ 3 treatment-emergent adverse events (TEAEs) occurred. Nine participants had grade ≤ 2 TAR-200–related TEAEs, with urgency, dysuria, and haematuria being most common. Two participants refused a second dosing cycle due to urinary urgency and frequency. Insertion and removal of TAR-200 was successful in all cases. Plasma gemcitabine concentrations remained below the lower limit of detection. Five participants (42%) had complete response (CR): four had pathological CR and one had CR based on visual assessment. Conclusions and clinical implications: TAR-200 appears to be safe and well tolerated, with encouraging preliminary efficacy in participants with IR NMIBC. This study lays the groundwork for the multiple phase 2 and 3 global studies that are currently on-going for TAR-200. Patient summary: In this study, researchers evaluated the safety of the novel drug delivery system TAR-200 in participants with intermediate-risk non-muscle-invasive bladder cancer. They concluded that TAR-200 was safe and well tolerated with promising antitumour activity. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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