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| Autor(es): Mostrar menos - |
Alonso, Joao Carlos Cardoso
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de Souza, Bianca Ribeiro
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Reis, Ianny Brum
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Camargo, Gabriela Cardoso de Arruda
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de Oliveira, Gabriela
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Salmazo, Maria Izabel de Barros Frazao
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Goncalves, Juliana Mattoso
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Roston, Jose Ronaldo de Castro
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Caria, Paulo Henrique Ferreira
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Santos, Andre da Silva
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de Freitas, Leandro Luiz Lopes
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Billis, Athanase
;
Duran, Nelson
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Favaro, Wagner Jose
Número total de Autores: 14
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| Tipo de documento: | Artigo Científico |
| Fonte: | INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES; v. 24, n. 24, p. 30-pg., 2023-12-01. |
| Resumo | |
This study assessed the safety and efficacy of OncoTherad (R) (MRB-CFI-1) nanoimmunotherapy for non-muscle invasive bladder cancer (NMIBC) patients unresponsive to Bacillus Calmette-Guerin (BCG) and explored its mechanisms of action in a bladder cancer microenvironment. A single-arm phase I/II study was conducted with 44 patients with NMIBC who were unresponsive to BCG treatment. Primary outcomes were pathological complete response (pCR) and relapse-free survival (RFS). Secondary outcomes comprised response duration and therapy safety. Patients' mean age was 65 years; 59.1% of them were refractory, 31.8% relapsed, and 9.1% were intolerant to BCG. Moreover, the pCR rate after 24 months reached 72.7% (95% CI), whereas the mean RFS reached 21.4 months. Mean response duration in the pCR group was 14.3 months. No patient developed muscle-invasive or metastatic disease during treatment. Treatment-related adverse events occurred in 77.3% of patients, mostly grade 1-2 events. OncoTherad (R) activated the innate immune system through toll-like receptor 4, leading to increased interferon signaling. This activation played a crucial role in activating CX3CR1(+) CD8 T cells, decreasing immune checkpoint molecules, and reversing immunosuppression in the bladder microenvironment. OncoTherad (R) has proved to be a safe and effective therapeutic option for patients with BCG-unresponsive NMIBC, besides showing likely advantages in tumor relapse prevention processes. (AU) | |
| Processo FAPESP: | 18/10052-1 - Novas Abordagens Terapêuticas para o Câncer de Bexiga Não-Músculo Invasivo (CBNMI): Uso Intravesical do Modificador de Resposta Biológica OncoTherad e Sua Associação com o Plasma Rico em Plaquetas (PRP) |
| Beneficiário: | Wagner José Fávaro |
| Modalidade de apoio: | Auxílio à Pesquisa - Regular |
| Processo FAPESP: | 20/03419-6 - Efeitos terapêuticos e toxicológicos da imunoterapia com OncoTherad (MRB-CFI-1) em pacientes com câncer de bexiga não-músculo invasivo recidivado não responsivo à terapia com Bacillus Calmette-Guérin (BCG) |
| Beneficiário: | Wagner José Fávaro |
| Modalidade de apoio: | Auxílio à Pesquisa - Regular |