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Development of Infigratinib-eluting Seeds for Localized Treatment of Non-muscle Invasive Bladder Cancer (NMIBC)

Subject Area Reproductive Medicine, Urology
Term from 2023 to 2024
Project identifier Deutsche Forschungsgemeinschaft (DFG) - Project number 520413928
 
Final Report Year 2025

Final Report Abstract

Non-muscle invasive bladder cancer (NMIBC) accounts for approximately 75% of all bladder cancers and is associated with a high recurrence rate. To prevent progression to a muscleinvasive, more locally advanced tumor stage, or complications such as bleeding, regular monitoring via cystoscopy and resection of any new tumor growth is required. The current standard treatment for NMIBC involves tumor resection followed by intravesical administration of chemotherapy or immunotherapy directly into the bladder. However, treatment is complicated by the fact that bladder cancer primarily affects older patients who often have comorbidities (e.g., cardiovascular diseases) and take corresponding medications (e.g., blood thinners). Since tumor resection can lead to bleeding and anesthesia carries its own risks, treating many older and multimorbid patients with NMIBC requires interdisciplinary cooperation between general practitioners, internists, urologists, and anesthesiologists. The project aimed to develop small drug-coated capsules ("seeds") that could be inserted into bladder tumors without anesthesia via cystoscopy to locally release a chemotherapeutic agent (infigratinib). NMIBC is known to have a high mutation rate in the FGFR (Fibroblast Growth Factor Receptor) gene. Infigratinib blocks the FGFR gene, potentially reducing or suppressing bladder cancer growth. The rationale for developing these coated seeds was to reduce invasive resections under general or local anesthesia and their potential complications. The project involved developing and optimizing: 1.) The seeds and their coating 2.) A device to implant the seeds into the bladder/tumor. Testing was conducted initially in laboratory cell colonies and subsequently in animal models. Mice were implanted with cell colonies under the skin on their flanks, and after adequate tumor growth, therapy was initiated. Four groups were compared: 1.) Mice receiving only oral placebo (saline solution) 2.) Mice receiving oral infigratinib 3.) Mice implanted with uncoated seeds and receiving oral placebo 4.) Mice implanted with infigratinib-coated seeds. The slowest tumor growth was observed in mice receiving oral infigratinib. Mice implanted with coated seeds often developed a thin membrane around the seeds, indicating a foreign body reaction with subsequent encapsulation. Analysis of blood samples obtained from tail vein punctures and tumors for infigratinib concentration is still pending. It is speculated that the diffusion of infigratinib into the tumor was significantly reduced due to the encapsulation, which could explain the lack of response to therapy. While therapy with drug-coated seeds or similar vehicles presents an interesting approach for NMIBC treatment, significant optimization is still needed, particularly regarding the membrane formation as a foreign body reaction. The seed applicator was developed in collaboration with the Faculty of Biomedical Engineering at the University of British Columbia, with a prototype created and evaluated by urologists.

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