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1. Enfortumab Vedotin Following Platinum Chemotherapy and Avelumab Maintenance in Patients with Metastatic Urothelial Carcinoma: A Retrospective Data from the ARON-2EV Study

Author

Fiala, Ondřej, Massari, Francesco, Basso, Umberto, Giannatempo, Patrizia, Grande, Enrique, Buti, Sebastiano, Myint, Zin W., De Giorgi, Ugo, Pichler, Renate, Grillone, Francesco, Ürün, Yüksel, Calabrò, Fabio, Bourlon, Maria T., Galli, Luca, Kanesvaran, Ravindran, Roviello, Giandomenico, Kucharz, Jakub, Rizzo, Mimma, Park, Se Hoon, Cerbone, Linda, Seront, Emmanuel, Messina, Carlo, Molina-Cerrillo, Javier, Santini, Daniele, Yano, Akihiro, Incorvaia, Lorena, Catalano, Martina, Pinto, Alvaro, Formisano, Luigi, Soares, Andrey, Facchini, Gaetano, Fornarini, Giuseppe, Poprach, Alexandr, Rebuzzi, Sara Elena, Nasso, Cecilia, Spinelli, Gian Paolo, Angel, Martin, Stellato, Marco, Tural, Deniz, Aurilio, Gaetano, Epstein, Ilana, Carrozza, Francesco, Monteiro, Fernando Sabino Marques, Benedetti, Giovanni, Büchler, Tomáš, Ortega, Cinzia, Zakopoulou, Roubini, Battelli, Nicola, Porta, Camillo, Bellmunt, Joaquin, Gupta, Shilpa, and Santoni, Matteo

Published
2024
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2. Real-World Primary Resistance to First-Line Immune-Based Combinations in Patients with Advanced Renal Cell Carcinoma (ARON-1)

Author

Santini, Daniele, Li, Haoran, Roviello, Giandomenico, Park, Se Hoon, Grande, Enrique, Kucharz, Jakub, Basso, Umberto, Fiala, Ondrej, Monteiro, Fernando Sabino Marques, Poprach, Alexandr, Buti, Sebastiano, Molina-Cerrillo, Javier, Catalano, Martina, Buchler, Tomas, Seront, Emmanuel, Ansari, Jawaher, Myint, Zin W., Ghosn, Marwan, Calabrò, Fabio, Kopp, Ray Manneh, Bhuva, Dipen, Bourlon, Maria T., Roberto, Michela, Di Civita, Mattia Alberto, Mollica, Veronica, Marchetti, Andrea, Soares, Andrey, Battelli, Nicola, Ricci, Marco, Kanesvaran, Ravindran, Bamias, Aristotelis, Porta, Camillo, Massari, Francesco, and Santoni, Matteo

Published
2024
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3. Real-World Impact of Upfront Cytoreductive Nephrectomy in Metastatic Non-Clear Cell Renal Cell Carcinoma Treated with First-Line Immunotherapy Combinations or Tyrosine Kinase Inhibitors (A Sub-Analysis from the ARON-1 Retrospective Study)

Author

Fiala, Ondřej, Buti, Sebastiano, Bamias, Aristotelis, Massari, Francesco, Pichler, Renate, Maruzzo, Marco, Grande, Enrique, De Giorgi, Ugo, Molina-Cerrillo, Javier, Seront, Emmanuel, Calabrò, Fabio, Myint, Zin W., Facchini, Gaetano, Kopp, Ray Manneh, Berardi, Rossana, Kucharz, Jakub, Vitale, Maria Giuseppa, Pinto, Alvaro, Formisano, Luigi, Büttner, Thomas, Messina, Carlo, Monteiro, Fernando Sabino M., Battelli, Nicola, Kanesvaran, Ravindran, Büchler, Tomáš, Kopecký, Jindřich, Santini, Daniele, Giudice, Giulia Claire, Porta, Camillo, and Santoni, Matteo

Published
2024
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4. Sex and survival outcomes in patients with renal cell carcinoma receiving first-line immune-based combinations

Author

Incorvaia, Lorena, Monteiro, Fernando Sabino Marques, Massari, Francesco, Park, Se Hoon, Roviello, Giandomenico, Fiala, Ondřej, Myint, Zin W., Kucharz, Jakub, Molina-Cerrillo, Javier, Santini, Daniele, Buttner, Thomas, Poprach, Alexandr, Kopecky, Jindrich, Zeppellini, Annalisa, Pichler, Martin, Buchler, Tomas, Pichler, Renate, Facchini, Gaetano, Fay, Andre Poisl, Soares, Andrey, Manneh, Ray, Iezzi, Laura, Kuronya, Zsofia, Russo, Antonio, Bourlon, Maria T., Bhuva, Dipen, Ansari, Jawaher, Kanesvaran, Ravindran, Grande, Enrique, Buti, Sebastiano, and Santoni, Matteo

Published
2024
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5. Global real-world experiences with pembrolizumab in advanced urothelial carcinoma after platinum-based chemotherapy: the ARON-2 study

Author

Massari, Francesco, Santoni, Matteo, Takeshita, Hideki, Okada, Yohei, Tapia, Jose Carlos, Basso, Umberto, Maruzzo, Marco, Scagliarini, Sarah, Büttner, Thomas, Fornarini, Giuseppe, Myint, Zin W., Galli, Luca, Souza, Vinicius Carrera, Pichler, Renate, De Giorgi, Ugo, Gandur, Nathalia, Lam, Elaine T., Gilbert, Danielle, Popovic, Lazar, Grande, Enrique, Mammone, Giulia, Berardi, Rossana, Crabb, Simon J., Kemp, Robert, Molina-Cerrillo, Javier, Freitas, Marcelo, Luz, Murilo, Iacovelli, Roberto, Calabrò, Fabio, Tural, Deniz, Atzori, Francesco, Küronya, Zsófia, Chiari, Rita, Campos, Saul, Caffo, Orazio, Fay, André P., Kucharz, Jakub, Zucali, Paolo Andrea, Rinck, José Augusto, Zeppellini, Annalisa, Bastos, Diogo Assed, Aurilio, Gaetano, Mota, Augusto, Trindade, Karine, Ortega, Cinzia, Sade, Juan Pablo, Rizzo, Mimma, Fiala, Ondřej, Vau, Nuno, Giannatempo, Patrizia, Barillas, Allan, Monteiro, Fernando Sabino M., Dauster, Breno, Mennitto, Alessia, Nogueira, Lucas, de Carvalho Fernandes, Roni, Seront, Emmanuel, Aceituno, Luís Garcia, Grillone, Francesco, Cutuli, Hernan Javier, Fernandez, Mauricio, Bassanelli, Maria, Kopp, Ray Manneh, Roviello, Giandomenico, Abahssain, Halima, Procopio, Giuseppe, Milella, Michele, Kopecky, Jindrich, Martignetti, Angelo, Messina, Carlo, Caitano, Manuel, Inman, Eva, Kanesvaran, Ravindran, Herchhorn, Daniel, Santini, Daniele, Bamias, Aristotelis, Bisonni, Renato, Mosca, Alessandra, Morelli, Franco, Maluf, Fernando, Soares, Andrey, Nunes, Fernando, Pinto, Alvaro, Zgura, Anca, Incorvaia, Lorena, Ansari, Jawaher, Zabalza, Ignacio Ortego, Landmesser, Johannes, Rizzo, Alessandro, Mollica, Veronica, Marchetti, Andrea, Rosellini, Matteo, Sorgentoni, Giulia, Battelli, Nicola, Buti, Sebastiano, Porta, Camillo, and Bellmunt, Joaquim

Published
2024
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6. Papillary Renal Cell Carcinoma: Outcomes for Patients Receiving First-line Immune-based Combinations or Tyrosine Kinase Inhibitors from the ARON-1 Study

Author

Massari, Francesco, Mollica, Veronica, Fiala, Ondrej, De Giorgi, Ugo, Kucharz, Jakub, Vitale, Maria Giuseppa, Molina-Cerrillo, Javier, Facchini, Gaetano, Seront, Emmanuel, Lenci, Edoardo, Bourlon, Maria T., Carrozza, Francesco, Pichler, Renate, Lolli, Cristian, Myint, Zin W., Kanesvaran, Ravindran, Torniai, Mariangela, Rescigno, Pasquale, Gomez de Liaño, Alfonso, Zakopoulou, Roubini, Buti, Sebastiano, Porta, Camillo, Grande, Enrique, and Santoni, Matteo

Published
2024
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7. Bone targeting agents, but not radiation therapy, improves survival in patients with bone metastases from advanced urothelial carcinoma receiving pembrolizumab: results from the ARON-2 study

Author

Santoni, Matteo, Massari, Francesco, Takeshita, Hideki, Tapia, Jose Carlos, Dionese, Michele, Pichler, Renate, Rizzo, Mimma, Lam, Elaine T., Grande, Enrique, Kemp, Robert, Molina-Cerrillo, Javier, Calabrò, Fabio, Tural, Deniz, Küronya, Zsófia, Kucharz, Jakub, Fiala, Ondrej, Seront, Emmanuel, Kopp, Ray Manneh, Abahssain, Halima, Kopecky, Jindrich, Martignetti, Angelo, Kanesvaran, Ravindran, Zakopoulou, Roubini, Ansari, Jawaher, Landmesser, Johannes, Mollica, Veronica, Porta, Camillo, Bellmunt, Joaquim, Salah, Samer, and Santini, Daniele

Published
2023
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8. Use of concomitant proton pump inhibitors, statins or metformin in patients treated with pembrolizumab for metastatic urothelial carcinoma: data from the ARON-2 retrospective study

Author

Fiala, Ondřej, Buti, Sebastiano, Takeshita, Hideki, Okada, Yohei, Massari, Francesco, Palacios, Georgia Anguera, Dionese, Michele, Scagliarini, Sarah, Büttner, Thomas, Fornarini, Giuseppe, Myint, Zin W., Galli, Luca, Souza, Vinicius Carrera, Pichler, Renate, De Giorgi, Ugo, Quiroga, María Natalia Gandur, Gilbert, Danielle, Popovic, Lazar, Grande, Enrique, Mammone, Giulia, Berardi, Rossana, Crabb, Simon J., Molina-Cerrillo, Javier, Freitas, Marcelo, Luz, Murilo, Iacovelli, Roberto, Calabrò, Fabio, Tural, Deniz, Atzori, Francesco, Küronya, Zsófia, Chiari, Rita, Campos, Saul, Caffo, Orazio, Fay, André P., Kucharz, Jakub, Zucali, Paolo Andrea, Rinck, José Augusto, Zeppellini, Annalisa, Bastos, Diogo Assed, Aurilio, Gaetano, Mota, Augusto, Trindade, Karine, Ortega, Cinzia, Sade, Juan Pablo, Rizzo, Mimma, Vau, Nuno, Giannatempo, Patrizia, Barillas, Allan, Monteiro, Fernando Sabino Marques, Dauster, Breno, Cattrini, Carlo, Nogueira, Lucas, de Carvalho Fernandes, Roni, Seront, Emmanuel, Aceituno, Luís Garcia, Grillone, Francesco, Cutuli, Hernan Javier, Fernandez, Mauricio, Bassanelli, Maria, Roviello, Giandomenico, Abahssain, Halima, Procopio, Giuseppe, Milella, Michele, Kopecky, Jindrich, Martignetti, Angelo, Messina, Carlo, Caitano, Manuel, Inman, Eva, Kanesvaran, Ravindran, Herchenhorn, Daniel, Santini, Daniele, Manneh, Ray, Bisonni, Renato, Zakopoulou, Roubini, Mosca, Alessandra, Morelli, Franco, Maluf, Fernando, Soares, Andrey, Nunes, Fernando, Pinto, Alvaro, Zgura, Anca, Incorvaia, Lorena, Ansari, Jawaher, Zabalza, Ignacio Ortego, Landmesser, Johannes, Rizzo, Alessandro, Mollica, Veronica, Sorgentoni, Giulia, Battelli, Nicola, Porta, Camillo, Bellmunt, Joaquim, and Santoni, Matteo

Published
2023
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9. Real-world effectiveness of pembrolizumab as first-line therapy for cisplatin-ineligible patients with advanced urothelial carcinoma: the ARON-2 study

Author

Santoni, Matteo, Myint, Zin W., Büttner, Thomas, Takeshita, Hideki, Okada, Yohei, Lam, Elaine T., Gilbert, Danielle, Küronya, Zsófia, Tural, Deniz, Pichler, Renate, Grande, Enrique, Crabb, Simon J., Kemp, Robert, Massari, Francesco, Scagliarini, Sarah, Iacovelli, Roberto, Vau, Nuno, Basso, Umberto, Maruzzo, Marco, Molina-Cerrillo, Javier, Galli, Luca, Bamias, Aristotelis, De Giorgi, Ugo, Zucali, Paolo Andrea, Rizzo, Mimma, Seront, Emmanuel, Popovic, Lazar, Caffo, Orazio, Buti, Sebastiano, Kanesvaran, Ravindran, Kopecky, Jindrich, Kucharz, Jakub, Zeppellini, Annalisa, Fiala, Ondřej, Landmesser, Johannes, Ansari, Jawaher, Giannatempo, Patrizia, Rizzo, Alessandro, Zabalza, Ignacio Ortego, Monteiro, Fernando Sabino M., Battelli, Nicola, Calabrò, Fabio, and Porta, Camillo

Published
2023
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10. Global Real-World Outcomes of Patients Receiving Immuno-Oncology Combinations for Advanced Renal Cell Carcinoma: The ARON-1 Study

Author

Santoni, Matteo, Massari, Francesco, Myint, Zin W., Iacovelli, Roberto, Pichler, Martin, Basso, Umberto, Kopecky, Jindrich, Kucharz, Jakub, Buti, Sebastiano, Rizzo, Mimma, Galli, Luca, Büttner, Thomas, De Giorgi, Ugo, Kanesvaran, Ravindran, Fiala, Ondřej, Grande, Enrique, Zucali, Paolo Andrea, Fornarini, Giuseppe, Bourlon, Maria T., Scagliarini, Sarah, Molina-Cerrillo, Javier, Aurilio, Gaetano, Matrana, Marc R., Pichler, Renate, Cattrini, Carlo, Büchler, Tomas, Seront, Emmanuel, Calabrò, Fabio, Pinto, Alvaro, Berardi, Rossana, Zgura, Anca, Mammone, Giulia, Ansari, Jawaher, Atzori, Francesco, Chiari, Rita, Bamias, Aristotelis, Caffo, Orazio, Procopio, Giuseppe, Bassanelli, Maria, Merler, Sara, Messina, Carlo, Küronya, Zsófia, Mosca, Alessandra, Bhuva, Dipen, Vau, Nuno, Incorvaia, Lorena, Rebuzzi, Sara Elena, Roviello, Giandomenico, Zabalza, Ignacio Ortego, Rizzo, Alessandro, Mollica, Veronica, Sorgentoni, Giulia, Monteiro, Fernando Sabino M., Montironi, Rodolfo, Battelli, Nicola, and Porta, Camillo

Published
2023
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11. Systemic Immune-Inflammation Index in Patients Treated With First-Line Immune Combinations for Metastatic Renal Cell Carcinoma: Insights From the ARON-1 Study

Author

Monteiro, Fernando Sabino Marques, Fiala, Ondřej, Massari, Francesco, Myint, Zin W., Kopecky, Jindrich, Kucharz, Jakub, Büttner, Thomas, Grande, Enrique, Bourlon, Maria Teresa, Molina-Cerrillo, Javier, Pichler, Renate, Buchler, Tomas, Seront, Emmanuel, Ansari, Jawaher, Bamias, Aristotelis, Bhuva, Dipen, Vau, Nuno, Porta, Camillo, Fay, Andre Poisl, and Santoni, Matteo

Published
2024
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12. Real-world Outcome of Patients with Advanced Renal Cell Carcinoma and Intermediate- or Poor-risk International Metastatic Renal Cell Carcinoma Database Consortium Criteria Treated by Immune-oncology Combinations: Differential Effectiveness by Risk Group?

Author

Santoni, Matteo, Buti, Sebastiano, Myint, Zin W., Maruzzo, Marco, Iacovelli, Roberto, Pichler, Martin, Kopecky, Jindrich, Kucharz, Jakub, Rizzo, Mimma, Galli, Luca, Büttner, Thomas, De Giorgi, Ugo, Kanesvaran, Ravindran, Fiala, Ondřej, Grande, Enrique, Zucali, Paolo Andrea, Kopp, Ray Manneh, Fornarini, Giuseppe, Bourlon, Maria T., Scagliarini, Sarah, Molina-Cerrillo, Javier, Aurilio, Gaetano, Matrana, Marc R., Pichler, Renate, Cattrini, Carlo, Büchler, Tomas, Massari, Francesco, Seront, Emmanuel, Calabrò, Fabio, Pinto, Alvaro, Berardi, Rossana, Zgura, Anca, Mammone, Giulia, Ansari, Jawaher, Atzori, Francesco, Chiari, Rita, Bamias, Aristotelis, Caffo, Orazio, Procopio, Giuseppe, Sunela, Kaisa, Bassanelli, Maria, Ortega, Cinzia, Grillone, Francesco, Landmesser, Johannes, Milella, Michele, Messina, Carlo, Küronya, Zsófia, Mosca, Alessandra, Bhuva, Dipen, Santini, Daniele, Vau, Nuno, Morelli, Franco, Incorvaia, Lorena, Rebuzzi, Sara Elena, Roviello, Giandomenico, Soares, Andrey, Bisonni, Renato, Bimbatti, Davide, Zabalza, Ignacio Ortego, Rizzo, Alessandro, Mollica, Veronica, Sorgentoni, Giulia, Monteiro, Fernando Sabino M., Battelli, Nicola, Bracarda, Sergio, and Porta, Camillo

Published
2024
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14. Enfortumab Vedotin Following Platinum Chemotherapy and Avelumab Maintenance in Patients with Metastatic Urothelial Carcinoma: A Retrospective Data from the ARON-2EV Study.

Author

Fiala, Ondřej, Massari, Francesco, Basso, Umberto, Giannatempo, Patrizia, Grande, Enrique, Buti, Sebastiano, Myint, Zin W., De Giorgi, Ugo, Pichler, Renate, Grillone, Francesco, Ürün, Yüksel, Calabrò, Fabio, Bourlon, Maria T., Galli, Luca, Kanesvaran, Ravindran, Roviello, Giandomenico, Kucharz, Jakub, Rizzo, Mimma, Park, Se Hoon, and Cerbone, Linda

Abstract

Background: Enfortumab vedotin (EV) has been approved for the treatment of patients with locally advanced/metastatic urothelial carcinoma (la/mUC) who previously received platinum-based chemotherapy followed by immune checkpoint inhibitors. However, the pivotal clinical trials did not include patients previously treated with avelumab maintenance therapy. Objective: The aim of the present retrospective analysis was to assess the effectiveness of EV following avelumab in patients with mUC enrolled in the ARON-2EV study. Patients and Methods: The study included 182 patients with mUC treated with EV following avelumab maintenance. The primary objective was to assess clinical outcomes, including progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and duration of response (DoR). Statistical analysis involved Fisher exact test, Kaplan–Meier method, log-rank test, and univariate/multivariate Cox proportional hazard regression models. Results: Median OS and PFS were 12.7 (95% CI 10.2–14.1) and 7.9 (95% CI 6.4–9.9) months, respectively. Complete response (CR) was achieved in 5% and partial response (PR) in 34% of patients, with an ORR of 39%. The DoR in patients who achieved CR/PR was 10.9 months (95% CI 8.1–11.4). The incidence of grade ≥ 3 peripheral neuropathy and skin rash was 9%, followed by 8% of grade ≥ 3 diarrhea and 4% of grade ≥ 3 hyperglycemia. Conclusions: The results of our large international retrospective study confirm the effectiveness of EV and endorse its use in the population of patients with mUC treated with EV following the frontline platinum-based chemotherapy and subsequent maintenance treatment with avelumab. [ABSTRACT FROM AUTHOR]

Published
2024
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16. Clinico-Pathological Features Influencing the Prognostic Role of Body Mass Index in Patients With Advanced Renal Cell Carcinoma Treated by Immuno-Oncology Combinations (ARON-1)

Author

Santoni, Matteo, Massari, Francesco, Myint, Zin W., Iacovelli, Roberto, Pichler, Martin, Basso, Umberto, Kopecky, Jindrich, Kucharz, Jakub, Buti, Sebastiano, Salfi, Alessia, Büttner, Thomas, De Giorgi, Ugo, Kanesvaran, Ravindran, Fiala, Ondřej, Grande, Enrique, Zucali, Paolo Andrea, Fornarini, Giuseppe, Bourlon, Maria T, Scagliarini, Sarah, Molina-Cerrillo, Javier, Aurilio, Gaetano, Matrana, Marc R, Pichler, Renate, Cattrini, Carlo, Büchler, Tomas, Seront, Emmanuel, Calabrò, Fabio, Pinto, Alvaro, Berardi, Rossana, Zgura, Anca, Mammone, Giulia, Ansari, Jawaher, Atzori, Francesco, Chiari, Rita, Zakopoulou, Roubini, Caffo, Orazio, Procopio, Giuseppe, Bassanelli, Maria, Zampiva, Ilaria, Messina, Carlo, Küronya, Zsófia, Mosca, Alessandra, Bhuva, Dipen, Vau, Nuno, Incorvaia, Lorena, Rebuzzi, Sara Elena, Roviello, Giandomenico, Zabalza, Ignacio Ortego, Rizzo, Alessandro, Mollica, Veronica, Catalini, Ilaria, Monteiro, Fernando Sabino M., Montironi, Rodolfo, Battelli, Nicola, Rizzo, Mimma, and Porta, Camillo

Published
2023
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17. Radiological Response and Neutrophil-to-Lymphocyte Ratio as Predictive Factors for Progression-Free and Overall Survival in Metastatic Renal Cell Carcinoma Patients Treated with Sunitinib

Author

Kucharz, Jakub, Dumnicka, Paulina, Giza, Agnieszka, Demkow, Urszula, Kusnierz–Cabala, Beata, Demkow, Tomasz, Wiechno, Pawel, COHEN, IRUN R., Editorial Board Member, LAJTHA, ABEL, Editorial Board Member, LAMBRIS, JOHN D., Editorial Board Member, PAOLETTI, RODOLFO, Editorial Board Member, REZAEI, NIMA, Editorial Board Member, and Pokorski, Mieczyslaw, editor

Published
2019
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18. Hand-Foot Syndrome and Progression-Free Survival in Patients Treated with Sunitinib for Metastatic Clear Cell Renal Cell Carcinoma

Author

Kucharz, Jakub, Budnik, Monika, Dumnicka, Paulina, Pastuszczak, Maciej, Kuśnierz-Cabala, Beata, Demkow, Tomasz, Popko, Katarzyna, Wiechno, Pawel, COHEN, IRUN R., Series Editor, LAJTHA, ABEL, Series Editor, Lambris, John, Series Editor, Paoletti, Rodolfo, Series Editor, Rezaei, Nima, Series Editor, and Pokorski, Mieczyslaw, editor

Published
2019
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19. Adverse Events of Cabozantinib as a Potential Prognostic Factor in Metastatic Renal Cell Carcinoma Patients: Real-World Experience in a Single-Center Retrospective Study

Author

Domański, Piotr, primary, Piętak, Mateusz, additional, Kruczyk, Barbara, additional, Jarosińska, Jadwiga, additional, Mydlak, Anna, additional, Demkow, Tomasz, additional, Darewicz, Marta, additional, Sikora-Kupis, Bożena, additional, Dumnicka, Paulina, additional, Kamzol, Wojciech, additional, and Kucharz, Jakub, additional

Published
2024
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21. Chemotherapy-Induced Takotsubo Syndrome

Author

Budnik, Monika, Kucharz, Jakub, Wiechno, Paweł, Demkow, Tomasz, Kochanowski, Janusz, Górska, Elżbieta, Opolski, Grzegorz, COHEN, IRUN R., Series Editor, LAJTHA, ABEL, Series Editor, LAMBRIS, JOHN D., Series Editor, PAOLETTI, RODOLFO, Series Editor, Rezaei, Nima, Series Editor, and Pokorski, Mieczyslaw, editor

Published
2018
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23. High FLT3 expression increases immune‐cell infiltration in the tumor microenvironment and correlates with prolonged disease‐free survival in patients with non‐small cell lung cancer.

Author

Kuncman, Łukasz, Orzechowska, Magdalena, Milecki, Tomasz, Kucharz, Jakub, and Fijuth, Jacek

Abstract

Most of the currently used cancer immunotherapies inhibit the programmed cell death protein 1 (PD1)–programmed cell death 1 ligand 1 (PDL1) axis of T‐cells. However, dendritic cells (DCs) controlled by natural killer (NK) cells via the FMS‐related tyrosine kinase 3 (FLT3) axis are necessary for activation of T‐cells. The aim of the study was to evaluate FLT3 as a prognostic factor and determine its role in immune infiltration (with emphasis on NK cells and DCs). Using The Cancer Genome Atlas (TCGA) database, we performed bioinformatic analysis of the gene expression datasets of 501 lung squamous cell carcinoma (LUSC) and 515 lung adenocarcinoma (LUAD) patient who had corresponding clinical data [analysis was performed in R (version 4.2.0)]. Disease‐free survival (DFS) differed between the FLT3‐low and FLT3‐high expression groups, respectively, in LUSC (61.0 vs 71.3 months P = 0.075) and LUAD (32.7 vs 47.5 months P = 0.045). A tumor microenvironment (TME) with high immune infiltration and rich in T‐cell exhaustion markers was observed in the FLT3‐high group. We showed overexpression of NK cell and DC gene signatures in the FLT3‐high expression group as well as overexpression of key effector genes of the cyclic GMP‐AMP synthase (cGAS)–stimulator of interferon genes protein (STING) pathway, which is crucial in response to radiotherapy. High expression of FLT3 in the TME was associated with immune cell infiltration (especially of NK cells and DCs), increased expression of T‐cell exhaustion markers and expression of effector genes of the cGAS‐STING pathway, which may consequently increase susceptibility to immunotherapy and radiotherapy. High FLT3 expression correlated with prolonged DFS in the LUSC and LUAD cohorts. [ABSTRACT FROM AUTHOR]

Published
2024
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24. Systemic Immune-Inflammation Index in Patients Treated With First-Line Immune Combinations for Metastatic Renal Cell Carcinoma: Insights From the ARON-1 Study.

Author

Marques Monteiro, Fernando Sabino, Fiala, Ondřej, Massari, Francesco, Myint, Zin W., Kopecky, Jindrich, Kucharz, Jakub, Büttner, Thomas, Grande, Enrique, Bourlon, Maria Teresa, Molina-Cerrillo, Javier, Pichler, Renate, Buchler, Tomas, Seront, Emmanuel, Ansari, Jawaher, Bamias, Aristotelis, Bhuva, Dipen, Vau, Nuno, Porta, Camillo, Fay, Andre Poisl, and Santoni, Matteo

Subjects
RENAL cell carcinoma, METASTASIS, BIOMARKERS, CANCER immunotherapy, KINASE inhibitors
Abstract

The treatment of metastatic renal cell carcinoma has evolved on last years. Nowadays immune-combinations are the standard treatment in first-line setting. There is no prognostic biomarker for metastatic renal cell carcinoma in the systemic immunotherapy treatment era. Systemic Immune-Inflammation Index is a cheap and readily available prognostic tool to be used in daily clinical practice. Background: Systemic treatment with immune combinations is the gold standard for metastatic renal cell carcinoma (mRCC) worldwide. The systemic immune-inflammation index (SII) is a prognostic marker for several types of malignant neoplasms, including mRCC, in the era of tyrosine kinase inhibitor (TKI) treatment. Data regarding the prognostic value of the SII in patients with mRCC treated with immunotherapy are scarce and controversial. Methods: We retrospectively collected the data of patients with mRCC from 56 centers in 18 countries. SII (Platelet × Neutrophil/Lymphocyte count) was calculated prior to the first systemic treatment and cut-off was defined by a survival receiver operating characteristic (ROC) analysis. The primary objective of our retrospective study was to assess the outcomes of patients treated with first-line immunotherapy. Results: Data from 1034 mRCC patients was collected and included in this analysis. The SII cut-off value was 1265. After a follow-up of 26.7 months, and the overall survival (OS) and progression-free survival (PFS) were 39.8 and 15.7 months, respectively. According to SII (low vs. high), patients with low-SII had longer OS (55.7 vs. 22.2 months, P < .001), better PFS (20.8 vs. 8.5 months, P < .001), and higher overall response rate (52 vs. 37%, P = .033). Conclusion: A high SII is associated with poor oncological outcomes in patients with mRCC. SII could be an easily accessible prognostic indicator for use in clinical practice. [ABSTRACT FROM AUTHOR]

Published
2024
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25. Systemic Immune-Inflammation Index in patients treated with first-line immune combinations for metastatic Renal Cell Carcinoma: insights from the ARON-1 study

Author

Monteiro, Fernando Sabino Marques, primary, Ondřej, Fiala, additional, Massari, Francesco, additional, Myint, Zin W., additional, Kopecky, Jindrich, additional, Kucharz, Jakub, additional, Büttner, Thomas, additional, Grande, Enrique, additional, Bourlon, Maria Teresa, additional, Molina-Cerrillo, Javier, additional, Pichler, Renate, additional, Buchler, Tomas, additional, Seront, Emmanuel, additional, Ansari, Jawaher, additional, Bamias, Aristotelis, additional, Bhuva, Dipen, additional, Vau, Nuno, additional, Porta, Camillo, additional, Fay, Andre Poisl, additional, and Santoni, Matteo, additional

Published
2023
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26. Geographical differences in the management of metastatic de novo renal cell carcinoma in the era of immune-combinations

Author

PORTA, Camillo, primary, BAMIAS, Aristotelis, additional, ZAKOPOULOU, Roubini, additional, MYINT, Zin W., additional, CAVASIN, Nicolò, additional, IACOVELLI, Roberto, additional, PICHLER, Martin, additional, KOPECKY, Jindrich, additional, KUCHARZ, Jakub, additional, RIZZO, Mimma, additional, GALLI, Luca, additional, BÜTTNER, Thomas, additional, DE GIORGI, Ugo, additional, KANESVARAN, Ravindran, additional, FIALA, Ondřej, additional, GRANDE, Enrique, additional, ZUCALI, Paolo A., additional, KOPP, Ray M., additional, FORNARINI, Giuseppe, additional, BOURLON, Maria T., additional, SCAGLIARINI, Sarah, additional, MOLINA-CERRILLO, Javier, additional, AURILIO, Gaetano, additional, MATRANA, Marc R., additional, PICHLER, Renate, additional, CATTRINI, Carlo, additional, BÜCHLER, Tomáš, additional, MASSARI, Francesco, additional, MOLLICA, Veronica, additional, SERONT, Emmanuel, additional, CALABRÒ, Fabio, additional, PINTO, Alvaro, additional, BERARDI, Rossana, additional, ZGURA, Anca, additional, MAMMONE, Giulia, additional, ANSARI, Jawaher, additional, ATZORI, Francesco, additional, CHIARI, Rita, additional, CAFFO, Orazio, additional, PROCOPIO, Giuseppe, additional, SUNELA, Kaisa, additional, BASSANELLI, Maria, additional, ORTEGA, Cinzia, additional, GRILLONE, Francesco, additional, LANDMESSER, Johannes, additional, MERLER, Sara, additional, MESSINA, Carlo, additional, KÜRONYA, Zsófia, additional, MOSCA, Alessandra, additional, BHUVA, Dipen, additional, SANTINI, Daniele, additional, VAU, Nuno, additional, MORELLI, Franco, additional, INCORVAIA, Lorena, additional, REBUZZI, Sara E., additional, ROVIELLO, Giandomenico, additional, SOARES, Andrey, additional, ZABALZA, Ignacio O., additional, RIZZO, Alessandro, additional, BISONNI, Renato, additional, PIERANTONI, Francesco, additional, SORGENTONI, Giulia, additional, MONTEIRO, Fernando S., additional, BATTELLI, Nicola, additional, BUTI, Sebastiano, additional, and SANTONI, Matteo, additional

Published
2023
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27. Real-world Outcome of Patients with Advanced Renal Cell Carcinoma and Intermediate- or Poor-risk International Metastatic Renal Cell Carcinoma Database Consortium Criteria Treated by Immune-oncology Combinations: Differential Effectiveness by Risk Group?

Author

Santoni, Matteo, primary, Buti, Sebastiano, additional, Myint, Zin W., additional, Maruzzo, Marco, additional, Iacovelli, Roberto, additional, Pichler, Martin, additional, Kopecky, Jindrich, additional, Kucharz, Jakub, additional, Rizzo, Mimma, additional, Galli, Luca, additional, Büttner, Thomas, additional, De Giorgi, Ugo, additional, Kanesvaran, Ravindran, additional, Fiala, Ondřej, additional, Grande, Enrique, additional, Zucali, Paolo Andrea, additional, Kopp, Ray Manneh, additional, Fornarini, Giuseppe, additional, Bourlon, Maria T., additional, Scagliarini, Sarah, additional, Molina-Cerrillo, Javier, additional, Aurilio, Gaetano, additional, Matrana, Marc R., additional, Pichler, Renate, additional, Cattrini, Carlo, additional, Büchler, Tomas, additional, Massari, Francesco, additional, Seront, Emmanuel, additional, Calabrò, Fabio, additional, Pinto, Alvaro, additional, Berardi, Rossana, additional, Zgura, Anca, additional, Mammone, Giulia, additional, Ansari, Jawaher, additional, Atzori, Francesco, additional, Chiari, Rita, additional, Bamias, Aristotelis, additional, Caffo, Orazio, additional, Procopio, Giuseppe, additional, Sunela, Kaisa, additional, Bassanelli, Maria, additional, Ortega, Cinzia, additional, Grillone, Francesco, additional, Landmesser, Johannes, additional, Milella, Michele, additional, Messina, Carlo, additional, Küronya, Zsófia, additional, Mosca, Alessandra, additional, Bhuva, Dipen, additional, Santini, Daniele, additional, Vau, Nuno, additional, Morelli, Franco, additional, Incorvaia, Lorena, additional, Rebuzzi, Sara Elena, additional, Roviello, Giandomenico, additional, Soares, Andrey, additional, Bisonni, Renato, additional, Bimbatti, Davide, additional, Zabalza, Ignacio Ortego, additional, Rizzo, Alessandro, additional, Mollica, Veronica, additional, Sorgentoni, Giulia, additional, Monteiro, Fernando Sabino M., additional, Battelli, Nicola, additional, Bracarda, Sergio, additional, and Porta, Camillo, additional

Published
2023
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29. Analysis of Factors Contributing to Adverse Events and Evaluation of Their Impact on Prognosis in Metastatic Renal Cell Carcinoma Patients—Real-World Experience in a Single-Center Retrospective Study and Narrative Review.

Author

Domański, Piotr, Piętak, Mateusz, Staneta, Szymon, Fortuniak, Weronika, Kruczyk, Barbara, Kobiernik, Adam, Bakuła, Piotr, Mydlak, Anna, Demkow, Tomasz, Sikora-Kupis, Bożena, Dumnicka, Paulina, and Kucharz, Jakub

Subjects
FACTOR analysis, RENAL cell carcinoma, PROPORTIONAL hazards models, BODY surface area, HUMAN carcinogenesis, PROGNOSIS, BODY mass index
Abstract

Background and Objectives: More than 430,000 new cases of renal cell carcinoma (RCC) were reported in 2020. Clear cell RCC, which occurs in 80% of cases, is often associated with mutations in the VHL gene, leading to dysregulation of hypoxia-induced transcription factors pathways and carcinogenesis. The purpose of this study is to examine the adverse events (AEs) of cabozantinib treatment and the relationship between individual patient factors and the frequency of their occurrence in detail. Materials and Methods: Seventy-one patients with metastatic RCC were treated with second or further lines of cabozantinib at the Department of Genitourinary Oncology, Maria Sklodowska-Curie National Research Institute of Oncology. Comprehensive data, including demographics, clinicopathological factors, and AEs, were collected from January 2017 to June 2021. This study evaluated the impact of various patient-related factors on the rate of adverse events and treatment tolerance using a Cox proportional hazards model. Results: Cabozantinib-induced AEs were significantly associated with body mass index (BMI), body surface area (BSA), IMDC prognostic score, and treatment line. Notably, patients receiving cabozantinib post-tyrosine kinase inhibitors reported fewer AEs. Dose reduction was unrelated to adverse event frequency, but patients requiring dose reduction were characterized with lower body mass and BSA but not BMI. Conclusions: The factors described make it possible to predict the incidence of AEs, which allows for faster detection and easier management, especially in the high-risk group. AEs should be reported in detail in real-world studies, as their occurrence has a significant impact on prognosis. [ABSTRACT FROM AUTHOR]

Published
2024
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33. Prognostic value of pan-immuneinflammation value and body mass index in geriatric patients with metastatic renal cell carcinoma treated with tyrosine kinase inhibitors as first line treatment. A single-center retrospective study.

Author

Domański, Piotr, Jarosińska, Jadwiga, Kruczyk, Barbara, Piętak, Mateusz, Mydlak, Anna, Demkow, Tomasz, Kuncman, Łukasz, Darewicz, Marta, Sikora-Kupis, Bożena, Michalski, Wojciech, and Kucharz, Jakub

Subjects
INFLAMMATION, BODY mass index, RENAL cell carcinoma, OLDER patients, KINASE inhibitors, METASTASIS
Abstract

Introduction: Geriatric patients with metastatic renal cell carcinoma (mRCC) are underrepresented in clinical trials. Evaluation of the efficacy of the treatment and assignation of individuals to proper prognostic groups is an absolute necessity to guarantee them the best possible care. Material and methods: A total of 138 geriatric patients with mRCC treated with first-line tyrosine kinase inhibitors (TKIs) at the Maria Skłodowska-Curie National Research Institute of Oncology were retrospectively analyzed to determine whether the body mass index (BMI) and pan-immune-inflammation value (PIV) are prognostic values for overall survival (OS) and progression-free survival (PFS) in this type of cancer. For this purpose, Cox's proportional hazard model was used. Results: The median duration of follow-up for surviving patients was 46.6 (95% CI: 17.4-75.8) months. The median OS and PFS were respectively 33.8 months (95% CI: 23.8-47.8) and 19.1 months (95% CI: 15.0-23.3). BMI (p = 0.034) and PIV (p < 0.001) were statistically significantly associated with OS, and PIV (p = 0.001) was statistically significantly associated with PFS. The risk of death for patients from the high-PIV group (cut-off point: 548) was 3.4 times higher than for those with lower PIV values. The corresponding risk of progression for patients from the high-PIV group was 2.2 times higher. The G8 geriatric screening tool was not identified as a prognostic factor. Conclusions: Lower PIV and obesity are associated with longer OS in geriatric mRCC patients treated with TKIs in the first line. These factors may be considered while making treatment decisions if further studies show the same results. [ABSTRACT FROM AUTHOR]

Published
2023
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34. First experience in treating advanced urothelial cancer with enfortumab vedotin. Single-centre retrospective study of patients qualified for a rescue access procedure.

Author

Sikora-Kupis, Bożena, Domański, Piotr, Fortuniak, Weronika, Kruczyk, Barbara, Staneta, Szymon, Piętak, Mateusz, Mydlak, Anna, Demkow, Tomasz, Dumnicka, Paulina, and Kucharz, Jakub

Subjects
ANTIBODY-drug conjugates, TRANSITIONAL cell carcinoma, CANCER chemotherapy, CANCER immunotherapy, DRUG efficacy
Abstract

Introduction: Urothelial carcinoma is the most common type of urinary tract malignancy. Current treatment options, including platinum-based chemotherapy or immunotherapy, present significant challenges, ranging from limited efficacy to severe toxicities. Recent developments in antibody-drug conjugates (ADC), such as enfortumab vedotin (EV), promise to significantly improve overall survival. The study aims to evaluate the efficacy and tolerability of EV. In addition, we highlight the observed benefits of next-line treatment after progression. Material and methods: This retrospective study involved 16 patients with advanced urothelial cancer treated with EV at the Department of Genitourinary Oncology, Maria Skłodowska-Curie National Research Institute of Oncology between November 2022 and November 2023. The study evaluated patients' medical history, response to EV treatment, and side effects. Notably, the study included patients who had already exhausted standard treatment options and who were treated with EV through a rescue access procedure. Results: Partial response was observed in 4 out of 9 (44%) patients with available imaging. Common terminology criteria for adverse events (AE) grade 3 and 4 were observed in 3 out of 16 patients, which subsequently required dose reduction. Conclusions: Enfortumab vedotin demonstrates effectiveness in real-world settings in treating advanced urothelial cancer. Proper management of AE in experienced centres may further prolong survival. Personalized treatment and the development of new ADC represent the future for improved patient outcomes. [ABSTRACT FROM AUTHOR]

Published
2023
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35. Activity of cabozantinib in further line treatment of metastatic clear cell renal cell carcinoma. Real-world experience in a single-center retrospective study

Author

Domański, Piotr, primary, Jarosińska, Jadwiga, additional, Kruczyk, Barbara, additional, Piętak, Mateusz, additional, Mydlak, Anna, additional, Demkow, Tomasz, additional, Kuncman, Łukasz, additional, Darewicz, Marta, additional, Sikora-Kupis, Bożena, additional, Dumnicka, Paulina, additional, and Kucharz, Jakub, additional

Published
2023
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36. Prognostic value of pan-immune-inflammation value and body mass index in geriatric patients with metastatic renal cell carcinoma treated with tyrosine kinase inhibitors as first line treatment. A single-center retrospective study

Author

Domański, Piotr, primary, Jarosińska, Jadwiga, additional, Kruczyk, Barbara, additional, Piętak, Mateusz, additional, Mydlak, Anna, additional, Demkow, Tomasz, additional, Kuncman, Łukasz, additional, Darewicz, Marta, additional, Sikora-Kupis, Bożena, additional, Michalski, Wojciech, additional, and Kucharz, Jakub, additional

Published
2023
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47. RRM2 gene expression depends on BAF180 subunit of SWISNF chromatin remodeling complex and correlates with abundance of tumor infiltrating lymphocytes in ccRCC

Author

Szarkowska, Joanna, Cwiek, Pawel, Szymanski, Michal, Rusetska, Natalia, Jancewicz, Iga, Stachowiak, Malgorzata, Swiatek, Monika, Luba, Maciej, Konopinski, Ryszard, Kubala, Szymon, Zub, Renata, Kucharz, Jakub, Wiechno, Pawel, Siedlecki, Janusz A, Markowicz, Sergiusz, Sarnowska, Elzbieta, and Sarnowski, Tomasz J

Subjects
Original Article
Abstract

About 40% of clear cell renal cell carcinoma (ccRCC) cases carry the pbrm1 mutation inactivating BAF180 subunit of the SWI/SNF chromatin remodeling complex (CRC). Here we show that the majority of transcriptomic changes appear at the stage I of ccRCC development. By contrast, the stage II ccRCC exhibits hyperactivation of DNA replication demonstrated by the overexpression of several genes, e.g., RRM1 and RRM2 genes encoding subunits of ribonucleotide reductase (RNR) complex. We found that the degree of RRM1 and RRM2 upregulation in ccRCC patients depends on pbrm1 mutation. We show that the BAF180 protein product of the PBRM1 gene directly binds to RRM1 and RRM2 loci. The BAF180 binding regions are targeted by regulatory proteins previously reported as SWI/SNF CRC interacting partners. BAF180 binding to RRMs loci correlates with enrichment of H3K27me3 in case of RRM1 and H3K14Ac on RRM2, indicating the existence of differential regulatory mechanism controlling expression of these genes. We found that the strong overexpression of RRM2 in ccRCC patient samples correlates with T cell infiltration. Surprisingly, the majority of tumor infiltrating lymphocytes (TILs) consisted of CD4(+) T cells. Furthermore, we show that exhausted CD4(+) T cells induced the expression of the RRM2 gene in the primary ccRCC cell line. Collectively, our results provide the link between PBRM1 loss, RRM2 expression and T cell infiltration, which may lead to the establishment of new treatment of this disease.

Published
2021

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