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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. Radiotherapy plus pembrolizumab for advanced urothelial carcinoma: results from the ARON-2 real-world study

Author

Rizzo, Mimma, Soares, Andrey, Grande, Enrique, Bamias, Aristotelis, Kopp, Ray Manneh, Lenci, Edoardo, Buttner, Thomas, Salah, Samer, Grillone, Francesco, de Carvalho, Icaro Thiago, Tapia, Jose Carlos, Gucciardino, Calogero, Pinto, Alvaro, Mennitto, Alessia, Abahssain, Halima, Rescigno, Pasquale, Myint, Zin, Takeshita, Hideki, Spinelli, Gian Paolo, Popovic, Lazar, Vitale, Maria Giuseppa, Fiala, Ondrej, Giannatempo, Patrizia, Zakopoulou, Roubini, Carrozza, Francesco, Massari, Francesco, Monteiro, Fernando Sabino Marques, Pace, Maria Paola, Giannini, Massimo, Roviello, Giandomenico, Porta, Camillo, Battelli, Nicola, Kanesvaran, Ravindran, and Santoni, Matteo

Published
2024
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5. Radiotherapy plus pembrolizumab for advanced urothelial carcinoma: results from the ARON-2 real-world study

Author

Mimma Rizzo, Andrey Soares, Enrique Grande, Aristotelis Bamias, Ray Manneh Kopp, Edoardo Lenci, Thomas Buttner, Samer Salah, Francesco Grillone, Icaro Thiago de Carvalho, Jose Carlos Tapia, Calogero Gucciardino, Alvaro Pinto, Alessia Mennitto, Halima Abahssain, Pasquale Rescigno, Zin Myint, Hideki Takeshita, Gian Paolo Spinelli, Lazar Popovic, Maria Giuseppa Vitale, Ondrej Fiala, Patrizia Giannatempo, Roubini Zakopoulou, Francesco Carrozza, Francesco Massari, Fernando Sabino Marques Monteiro, Maria Paola Pace, Massimo Giannini, Giandomenico Roviello, Camillo Porta, Nicola Battelli, Ravindran Kanesvaran, and Matteo Santoni

Subjects
ARON-2 study, Pembrolizumab, Radiation therapy, Stereotactic radiation therapy, Urothelial carcinoma, Real-world data, Medicine, Science
Abstract

Abstract The addition of metastasis-directed radiotherapy (MDRT) to immunotherapy in patients with advanced urothelial carcinoma (aUC) has shown promising results. We report the real-world data from the ARON-2 study (NCT05290038) on the impact of conventional (CRT) or stereotactic body radiotherapy (SBRT) on the outcome of aUC patients receiving pembrolizumab after platinum-based-chemotherapy. Medical records of 837 patients were reviewed from 60 institutions in 20 countries. Two hundred and sixty-two patients (31%) received radiotherapy (cohort A), of whom 193 (23%) received CRT and 69 (8%) received SBRT. Patients were assessed for overall survival (OS), progression-free survival (PFS), and overall response rate (ORR). Univariate and multivariate analyses were used to explore the association of variables of interest with OS and PFS. With a median follow-up of 22.7 months, the median OS was 10.2 months, 6.8 months and 16.0 months in no RT, CRT and SBRT subgroups (p = 0.005), with an 1y-OS rates of 47%, 34% and 61%, respectively (p

Published
2024
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6. 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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7. Adjuvant Nivolumab in High-Risk Muscle-Invasive Urothelial Carcinoma: Expanded Efficacy From CheckMate 274

Author

Galsky, Matthew D., Witjes, Johannes Alfred, Gschwend, Jürgen E., Milowsky, Matthew I., Schenker, Michael, Valderrama, Begoña P., Tomita, Yoshihiko, Bamias, Aristotelis, Lebret, Thierry, Shariat, Shahrokh F., Park, Se Hoon, Agerbaek, Mads, Jha, Gautam, Stenner, Frank, Ye, Dingwei, Giudici, Fabio, Dutta, Santanu, Askelson, Margarita, Nasroulah, Federico, Zhang, Joshua, Brophy, Lynne, and Bajorin, Dean F.

Published
2024
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9. Association of the Time to Immune Checkpoint Inhibitor (ICI) Initiation and Outcomes With Second Line ICI in Patients With Advanced Urothelial Carcinoma

Author

Talukder, Rafee, Makrakis, Dimitrios, Lin, Genevieve Ihsiu, Diamantopoulos, Leonidas N, Dawsey, Scott, Gupta, Shilpa, Carril-Ajuria, Lucia, Castellano, Daniel, de Kouchkovsky, Ivan, Jindal, Tanya, Koshkin, Vadim S, Park, Joseph J, Alva, Ajjai, Bilen, Mehmet A, Stewart, Tyler F, McKay, Rana R, Tripathi, Nishita, Agarwal, Neeraj, Vather-Wu, Naomi, Zakharia, Yousef, Morales-Barrera, Rafael, Devitt, Michael E, Cortellini, Alessio, Fulgenzi, Claudia Angela Maria, Pinato, David J, Nelson, Ariel, Hoimes, Christopher J, Gupta, Kavita, Gartrell, Benjamin A, Sankin, Alex, Tripathi, Abhishek, Zakopoulou, Roubini, Bamias, Aristotelis, Murgic, Jure, Fröbe, Ana, Rodriguez-Vida, Alejo, Drakaki, Alexandra, Liu, Sandy, Lu, Eric, Kumar, Vivek, Lorenzo, Giuseppe Di, Joshi, Monika, Isaacsson-Velho, Pedro, Buznego, Lucia Alonso, Duran, Ignacio, Moses, Marcus, Barata, Pedro, Sonpavde, Guru, Wright, Jonathan L, Yu, Evan Y, Montgomery, Robert Bruce, Hsieh, Andrew C, Grivas, Petros, and Khaki, Ali Raza

Subjects
Cancer, Clinical Research, Humans, Immune Checkpoint Inhibitors, Carcinoma, Transitional Cell, Retrospective Studies, Cohort Studies, Treatment Outcome, Urinary Bladder Neoplasms, Bladder cancer, Immunotherapy, Platinum resistance, Checkpoint Inhibitor, Outcomes, Oncology and Carcinogenesis, Public Health and Health Services, Oncology & Carcinogenesis
Abstract

BackgroundEarly progression on first-line (1L) platinum-based therapy or between therapy lines may be a surrogate of more aggressive disease and poor outcomes in advanced urothelial carcinoma (aUC), but its prognostic role regarding immune checkpoint inhibitor (ICI) response and survival is unclear. We hypothesized that shorter time until start of second-line (2L) ICI would be associated with worse outcomes in aUC.Patients and methodsWe performed a retrospective multi-institution cohort study in patients with aUC treated with 1L platinum-based chemotherapy, who received 2L ICI. Patients receiving switch maintenance ICI were excluded. We defined time to 2L ICI therapy as the time between the start of 1L platinum-based chemotherapy to the start of 2L ICI and categorized patients a priori into 1 of 3 groups: less than 3 months versus 3-6 months versus more than 6 months. We calculated overall response rate (ORR) with 2L ICI, progression-free survival (PFS) and overall survival (OS) from the start of 2L ICI. ORR was compared among the 3 groups using multivariable logistic regression, and PFS, OS using cox regression. Multivariable models were adjusted for known prognostic factors.ResultsWe included 215, 215, and 219 patients in the ORR, PFS, and OS analyses, respectively, after exclusions. ORR difference did not reach statistical significance between patients with less than 3 months versus 3-6 months versus more than 6 months to 2L ICI. However, PFS (HR 1.64; 95% CI 1.02-2.63) and OS (HR 1.77; 95% CI 1.10-2.84) was shorter among those with time to 2L ICI less than 3 months compared to those who initiated 2L ICI more than 6 months.ConclusionAmong patients with aUC treated with 2L ICI, time to 2L ICI less than 3 months was associated with lower, but not significantly different ORR, but shorter PFS and OS compared to 2L ICI more than 6 months. This highlights potential cross resistance mechanisms between ICI and platinum-based chemotherapy.

Published
2022

10. Association of prior local therapy and outcomes with programmed‐death ligand‐1 inhibitors in advanced urothelial cancer

Author

Makrakis, Dimitrios, Talukder, Rafee, Diamantopoulos, Leonidas N, Carril-Ajuria, Lucia, Castellano, Daniel, De Kouchkovsky, Ivan, Koshkin, Vadim S, Park, Joseph J, Alva, Ajjai, Bilen, Mehmet A, Stewart, Tyler F, McKay, Rana R, Santos, Victor S, Agarwal, Neeraj, Jain, Jayanshu, Zakharia, Yousef, Morales-Barrera, Rafael, Devitt, Michael E, Grant, Michael, Lythgoe, Mark P, Pinato, David J, Nelson, Ariel, Hoimes, Christopher J, Shreck, Evan, Gartrell, Benjamin A, Sankin, Alex, Tripathi, Abhishek, Zakopoulou, Roubini, Bamias, Aristotelis, Murgic, Jure, Fröbe, Ana, Rodriguez-Vida, Alejo, Drakaki, Alexandra, Liu, Sandy, Kumar, Vivek, Di Lorenzo, Giuseppe, Joshi, Monika, Isaacsson-Velho, Pedro, Buznego, Lucia Alonso, Duran, Ignacio, Moses, Marcus, Barata, Pedro, Sonpavde, Guru, Yu, Evan Y, Wright, Jonathan L, Grivas, Petros, and Khaki, Ali Raza

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Good Health and Well Being, Humans, Immune Checkpoint Inhibitors, Retrospective Studies, Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, bladder cancer, urinary tract neoplasms, urothelial carcinoma, immune checkpoint inhibitors, immunotherapy, outcomes, #uroonc, #utuc, #BladderCancer, #blcsm, Urology & Nephrology, Clinical sciences, Oncology and carcinogenesis
Abstract

ObjectivesTo compare clinical outcomes with programmed-death ligand-1 immune checkpoint inhibitors (ICIs) in patients with advanced urothelial carcinoma (aUC) who have vs have not undergone radical surgery (RS) or radiation therapy (RT) prior to developing metastatic disease.Patients and methodsWe performed a retrospective cohort study collecting clinicopathological, treatment and outcomes data for patients with aUC receiving ICIs across 25 institutions. We compared outcomes (observed response rate [ORR], progression-free survival [PFS], overall survival [OS]) between patients with vs without prior RS, and by type of prior locoregional treatment (RS vs RT vs no locoregional treatment). Patients with de novo advanced disease were excluded. Analysis was stratified by treatment line (first-line and second-line or greater [second-plus line]). Logistic regression was used to compare ORR, while Kaplan-Meier analysis and Cox regression were used for PFS and OS. Multivariable models were adjusted for known prognostic factors.ResultsWe included 562 patients (first-line: 342 and second-plus line: 220). There was no difference in outcomes based on prior locoregional treatment among those treated with first-line ICIs. In the second-plus-line setting, prior RS was associated with higher ORR (adjusted odds ratio 2.61, 95% confidence interval [CI]1.19-5.74]), longer OS (adjusted hazard ratio [aHR] 0.61, 95% CI 0.42-0.88) and PFS (aHR 0.63, 95% CI 0.45-0.89) vs no prior RS. This association remained significant when type of prior locoregional treatment (RS and RT) was modelled separately.ConclusionPrior RS before developing advanced disease was associated with better outcomes in patients with aUC treated with ICIs in the second-plus-line but not in the first-line setting. While further validation is needed, our findings could have implications for prognostic estimates in clinical discussions and benchmarking for clinical trials. Limitations include the study's retrospective nature, lack of randomization, and possible selection and confounding biases.

Published
2022

11. Association Between Sites of Metastasis and Outcomes With Immune Checkpoint Inhibitors in Advanced Urothelial Carcinoma

Author

Makrakis, Dimitrios, Talukder, Rafee, Lin, Genevieve Ihsiu, Diamantopoulos, Leonidas N, Dawsey, Scott, Gupta, Shilpa, Carril-Ajuria, Lucia, Castellano, Daniel, de Kouchkovsky, Ivan, Koshkin, Vadim S, Park, Joseph J, Alva, Ajjai, Bilen, Mehmet A, Stewart, Tyler F, McKay, Rana R, Tripathi, Nishita, Agarwal, Neeraj, Vather-Wu, Naomi, Zakharia, Yousef, Morales-Barrera, Rafael, Devitt, Michael E, Cortellini, Alessio, Fulgenzi, Claudia Angela Maria, Pinato, David J, Nelson, Ariel, Hoimes, Christopher J, Gupta, Kavita, Gartrell, Benjamin A, Sankin, Alex, Tripathi, Abhishek, Zakopoulou, Roubini, Bamias, Aristotelis, Murgic, Jure, Fröbe, Ana, Rodriguez-Vida, Alejo, Drakaki, Alexandra, Liu, Sandy, Lu, Eric, Kumar, Vivek, Lorenzo, Giuseppe Di, Joshi, Monika, Isaacsson-Velho, Pedro, Buznego, Lucia Alonso, Duran, Ignacio, Moses, Marcus, Jang, Albert, Barata, Pedro, Sonpavde, Guru, Yu, Evan Y, Montgomery, Robert Bruce, Grivas, Petros, and Khaki, Ali Raza

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Immunology, Liver Disease, Orphan Drug, Cancer, Immunotherapy, Clinical Research, Rare Diseases, Digestive Diseases, Precision Medicine, Carcinoma, Transitional Cell, Humans, Immune Checkpoint Inhibitors, Liver Neoplasms, Retrospective Studies, Urinary Bladder Neoplasms, Bladder cancer, Immune checkpoint inhibitors, Advanced urothelial carcinoma, Outcomes, Metastatic cancer, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundSites of metastasis have prognostic significance in advanced urothelial carcinoma (aUC), but more information is needed regarding outcomes based on metastatic sites in patients treated with immune checkpoint inhibitors (ICI). We hypothesized that presence of liver/bone metastases would be associated with worse outcomes with ICI.MethodsWe identified a retrospective cohort of patients with aUC across 26 institutions, collecting demographics, clinicopathological, treatment, and outcomes information. Outcomes were compared with logistic (observed response rate; ORR) and Cox (progression-free survival; PFS, overall survival; OS) regression between patients with/without metastasis beyond lymph nodes (LN) and those with/without bone/liver/lung metastasis. Analysis was stratified by 1st or 2nd+ line.ResultsWe identified 917 ICI-treated patients: in the 1st line, bone/liver metastases were associated with shorter PFS (Hazard ratio; HR: 1.65 and 2.54), OS (HR: 1.60 and 2.35, respectively) and lower ORR (OR: 0.48 and 0.31). In the 2nd+ line, bone/liver metastases were associated with shorter PFS (HR: 1.71 and 1.62), OS (HR: 1.76 and 1.56) and, for bone-only metastases, lower ORR (OR: 0.29). In the 1st line, LN-confined metastasis was associated with longer PFS (HR: 0.53), OS (HR:0.49) and higher ORR (OR: 2.97). In the 2nd+ line, LN-confined metastasis was associated with longer PFS (HR: 0.47), OS (HR: 0.54), and higher ORR (OR: 2.79); all associations were significant.ConclusionBone and/or liver metastases were associated with worse, while LN-confined metastases were associated with better outcomes in patients with aUC receiving ICI. These findings in a large population treated outside clinical trials corroborate data from trial subset analyses.

Published
2022

12. 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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13. Overall Survival by Response to First-line Induction Treatment with Atezolizumab plus Platinum-based Chemotherapy or Placebo plus Platinum-based Chemotherapy for Metastatic Urothelial Carcinoma

Author

Enrique Grande, Aristotelis Bamias, Matthew D. Galsky, Eiji Kikuchi, Ian D. Davis, José Ángel Arranz, Arash Rezazadeh Kalebasty, Xavier Garcia del Muro, Se Hoon Park, Ugo De Giorgi, Boris Alekseev, Marina Mencinger, Kouji Izumi, Javier Puente, Jian-Ri Li, Sandrine Bernhard, Alan Nicholas, Julie Telliez, and Maria De Santis

Subjects
Atezolizumab, Cancer immunotherapy, First line, IMvigor130, Induction chemotherapy, Maintenance treatment, Diseases of the genitourinary system. Urology, RC870-923, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Standard-of-care first-line treatment for metastatic urothelial carcinoma (mUC) is platinum-based chemotherapy (CTx). Maintenance immunotherapy is a treatment option for patients without progressive disease (PD) after induction CTx. IMvigor130 was a randomised, phase 3 study evaluating atezolizumab plus platinum-based CTx (arm A), atezolizumab monotherapy (arm B), or placebo plus platinum-based CTx (arm C) as first-line treatment for mUC. The primary progression-free survival (PFS) analysis showed a statistically significant PFS benefit favouring arm A versus arm C, which did not translate into overall survival (OS) benefit at the final OS analysis. We report exploratory analyses based on response to combination induction treatment (arm A vs arm C) using final OS data. Post-induction OS was analysed for patients without PD during induction (4–6 CTx cycles) who received at least one dose of single-agent atezolizumab/placebo maintenance treatment. Post-progression OS was analysed for patients with PD during induction CTx. Addition of atezolizumab to CTx did not impact OS outcomes, regardless of response to induction CTx, with hazard ratios of 0.84 (95% confidence interval [CI] 0.63–1.10) for patients without PD and 0.75 (95% CI 0.54–1.05) for those with PD during induction CTx. Treatment effects appeared to be greatest for patients treated with cisplatin and for those with PD-L1–high tumours. Patient summary: The IMvigor130 trial showed that addition of atezolizumab to chemotherapy (CTx) did not improve survival over CTx alone in patients with bladder cancer. Overall, patients whose cancer did not progress during initial treatment tended to live longer than patients whose cancer did progress, but addition of atezolizumab to CTx did not help either group live longer in comparison to CTx alone. However, the results suggest that patients who received a certain CTx drug (cisplatin) or who had high levels of a marker called PD-L1 in their tumour may get the most improvement from addition of atezolizumab to CTx.The IMvigor130 trial is registered on ClinicalTrials.gov as NCT02807636.

Published
2023
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15. Exposure‐response relationship of ramucirumab in RANGE, a randomized phase III trial in advanced urothelial carcinoma refractory to platinum therapy

Author

Wit, Ronald, Powles, Thomas, Castellano, Daniel, Necchi, Andrea, Lee, Jae‐Lyun, Heijden, Michiel S, Matsubara, Nobuaki, Bamias, Aristotelis, Fléchon, Aude, Sternberg, Cora N, Drakaki, Alexandra, Yu, Evan Y, Zimmermann, Annamaria H, Long, Amanda, Walgren, Richard A, Gao, Ling, Bell‐McGuinn, Katherine M, and Petrylak, Daniel P

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Cancer, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Transitional Cell, Docetaxel, Humans, Platinum, Urinary Bladder Neoplasms, exposure-response, overall survival, progression-free survival, ramucirumab, urothelial carcinoma, Pharmacology and Pharmaceutical Sciences, Pharmacology & Pharmacy, Pharmacology and pharmaceutical sciences
Abstract

AimsPatients with advanced urothelial carcinoma (UC) who progress after platinum-based chemotherapy have a poor prognosis, and there is a medical need to improve current treatment options. Ramucirumab plus docetaxel significantly improved progression-free survival but not overall survival (OS) in platinum-refractory advanced UC (RANGE trial; NCT02426125). Here, we report the exposure-response (ER) of ramucirumab plus docetaxel using data from the RANGE trial.MethodsPharmacokinetic (PK) samples were collected (cycle 1-3, 5, 9 [day 1] and 30 days from treatment discontinuation), and PK data were analysed using population PK (popPK) analysis. The minimum ramucirumab concentration after first dose administration (Cmin,1 , or trough concentration immediately prior to the second dose) was derived by popPK analysis and used as the exposure parameter for ER analysis. Cox proportional hazards regression models and matched case-control analyses were used to evaluate the relationship between Cmin,1 and OS. The Cmin,1 relationship with safety was assessed descriptively.ResultsSeveral poor prognostic factors (ECOG 1, haemoglobin concentration

Published
2022

16. Response and Outcomes to Immune Checkpoint Inhibitors in Advanced Urothelial Cancer Based on Prior Intravesical Bacillus Calmette-Guerin

Author

Talukder, Rafee, Makrakis, Dimitrios, Diamantopoulos, Leonidas N, Carril-Ajuria, Lucia, Castellano, Daniel, De Kouchkovsky, Ivan, Koshkin, Vadim S, Park, Joseph J, Alva, Ajjai, Bilen, Mehmet A, Stewart, Tyler F, McKay, Rana R, Santos, Victor S, Agarwal, Neeraj, Jain, Jayanshu, Zakharia, Yousef, Morales-Barrera, Rafael, Devitt, Michael E, Grant, Michael, Lythgoe, Mark P, Pinato, David J, Nelson, Ariel, Hoimes, Christopher J, Shreck, Evan, Gartrell, Benjamin A, Sankin, Alex, Tripathi, Abhishek, Zakopoulou, Roubini, Bamias, Aristotelis, Murgic, Jure, Fröbe, Ana, Rodriguez-Vida, Alejo, Drakaki, Alexandra, Liu, Sandy, Kumar, Vivek, Lorenzo, Giuseppe Di, Joshi, Monika, Velho, Pedro Isaacsson, Buznego, Lucia Alonso, Duran, Ignacio, Moses, Marcus, Barata, Pedro, Sonpavde, Guru, Yu, Evan Y, Wright, Jonathan L, Grivas, Petros, and Khaki, Ali Raza

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Immunology, Precision Medicine, Cancer, 6.1 Pharmaceuticals, Good Health and Well Being, Adjuvants, Immunologic, Administration, Intravesical, BCG Vaccine, Carcinoma, Transitional Cell, Humans, Immune Checkpoint Inhibitors, Neoplasm Recurrence, Local, Retrospective Studies, Urinary Bladder Neoplasms, Bladder cancer, BCG, Immunotherapy, Outcomes, Urinary tract neoplasms, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundImmune checkpoint inhibitors (ICI) improve overall survival (OS) in patients with locally advanced, unresectable, or metastatic urothelial carcinoma (aUC), but response rates can be modest. We compared outcomes between patients with and without prior intravesical Bacillus Calmette-Guerin (BCG), who received ICI for aUC, hypothesizing that prior intravesical BCG would be associated with worse outcomes.Patients and methodsWe performed a retrospective cohort study across 25 institutions in US and Europe. We compared observed response rate (ORR) using logistic regression; progression-free survival (PFS) and OS using Kaplan-Meier and Cox proportional hazards. Analyses were stratified by treatment line (first line/salvage) and included multivariable models adjusting for known prognostic factors.ResultsA total of 1026 patients with aUC were identified; 614, 617, and 638 were included in ORR, OS, PFS analyses, respectively. Overall, 150 pts had history of prior intravesical BCG treatment. ORR to ICI was similar between those with and without prior intravesical BCG exposure in both first line and salvage settings (adjusted odds radios 0.55 [P= .08] and 1.65 [P= .12]). OS (adjusted hazard ratios 1.05 [P= .79] and 1.13 [P= .49]) and PFS (adjusted hazard ratios 1.12 [P= .55] and 0.87 [P= .39]) were similar between those with and without intravesical BCG exposure in first line and salvage settings.ConclusionPrior intravesical BCG was not associated with differences in response and survival in patients with aUC treated with ICI. Limitations include retrospective nature, lack of randomization, presence of selection and confounding biases. This study provides important preliminary data that prior intravesical BCG exposure may not impact ICI efficacy in aUC.

Published
2022

17. Defining Oligometastatic Bladder Cancer: A Systematic Review

Author

Aristotelis Bamias, Arnulf Stenzl, Flora Zagouri, Angeliki Andrikopoulou, and Peter Hoskin

Subjects
Definition, Local therapies, Oligometastatic bladder cancer, Systematic review, Diseases of the genitourinary system. Urology, RC870-923, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Context: Unlike other cancers, the concept of oligometastatic disease (OMD) in bladder cancer (BC) has not been systematically investigated. There is therefore a need to develop universally accepted definitions and guidelines for the management of oligometastatic BC (OMBC). Objective: To conduct a systematic review to assist a European consensus group in producing a definition of OMBC and to provide recommendations on staging and local therapies. Evidence acquisition: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was followed. Abstracts for articles focused on BC that addressed the issue of OMBC and provided a definition of oligometastatic status were selected. We collected data on the number of metastases, the number of metastases per organ, the number of organs involved, and metastatic sites that were excluded. Evidence synthesis: Sixteen eligible articles were retrieved (9 retrospective series involving 330 patients, 4 reviews, 1 consensus statement, 1 guideline paper, and 1 ongoing prospective phase 2 trial). A maximum of three to five metastatic lesions were compatible with the definition of OMBC. The number of organs involved and lesion size were not universally included in the OMBC definitions. OMD categories studied included synchronous OMBC, oligorecurrence, and oligoprogression. 18F-Fluorodeoxyglucose positron emission tomography combined with computed tomography was used in addition to conventional imaging for OMD detection. Surgery and radiotherapy were both used. Systemic chemotherapy was also used in all studies. Conclusions: There is little information on OMBC in the literature. Our systematic review revealed that only three to five metastatic sites amenable to surgery or radiotherapy that respond to systemic therapy is the setting most frequently chosen for a combination of systemic treatment and metastases-directed therapy. This setting could represent a basis for future prospective studies on OMBC. Patient summary: Oligometastatic bladder cancer is a disease state in which favorable outcomes can be expected after a treatment combination of systemic therapy, plus surgery and/or radiotherapy for sites of bladder cancer metastasis. Our systematic review showed a lack of meaningful evidence to define this disease state. There is an urgent need to develop organized research in this field.

Published
2023
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18. 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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20. 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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21. Predictive biomarkers for survival benefit with ramucirumab in urothelial cancer in the RANGE trial

Author

van der Heijden, Michiel S, Powles, Thomas, Petrylak, Daniel, de Wit, Ronald, Necchi, Andrea, Sternberg, Cora N, Matsubara, Nobuaki, Nishiyama, Hiroyuki, Castellano, Daniel, Hussain, Syed A, Bamias, Aristotelis, Gakis, Georgios, Lee, Jae-Lyun, Tagawa, Scott T, Vaishampayan, Ulka, Aragon-Ching, Jeanny B, Eigl, Bernie J, Hozak, Rebecca R, Rasmussen, Erik R, Xia, Meng Summer, Rhodes, Ryan, Wijayawardana, Sameera, Bell-McGuinn, Katherine M, Aggarwal, Amit, and Drakaki, Alexandra

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Immunology, Clinical Research, Genetic Testing, Cancer, Genetics, Good Health and Well Being, Antibodies, Monoclonal, Humanized, B7-H1 Antigen, Biomarkers, Biomarkers, Tumor, Carcinoma, Transitional Cell, Humans, Urinary Bladder Neoplasms
Abstract

The RANGE study (NCT02426125) evaluated ramucirumab (an anti-VEGFR2 monoclonal antibody) in patients with platinum-refractory advanced urothelial carcinoma (UC). Here, we use programmed cell death-ligand 1 (PD-L1) immunohistochemistry (IHC) and transcriptome analysis to evaluate the association of immune and angiogenesis pathways, and molecular subtypes, with overall survival (OS) in UC. Higher PD-L1 IHC and immune pathway scores, but not angiogenesis scores, are associated with greater ramucirumab OS benefit. Additionally, Basal subtypes, which have higher PD-L1 IHC and immune/angiogenesis pathway scores, show greater ramucirumab OS benefit compared to Luminal subtypes, which have relatively lower scores. Multivariable analysis suggests patients from East Asia as having lower immune/angiogenesis signature scores, which correlates with decreased ramucirumab OS benefit. Our data highlight the utility of multiple biomarkers including PD-L1, molecular subtype, and immune phenotype in identifying patients with UC who might derive the greatest benefit from treatment with ramucirumab.

Published
2022

22. Landscape of Interactions between Stromal and Myeloid Cells in Ileal Crohn’s Disease; Indications of an Important Role for Fibroblast-Derived CCL-2

Author

Nikolas Dovrolis, Vassilis Valatas, Ioannis Drygiannakis, Eirini Filidou, Michail Spathakis, Leonidas Kandilogiannakis, Gesthimani Tarapatzi, Konstantinos Arvanitidis, Giorgos Bamias, Stergios Vradelis, Vangelis G. Manolopoulos, Vasilis Paspaliaris, and George Kolios

Subjects
cell–cell communication, Crohn’s disease (CD), pro-inflammatory differentiation, stromal cells, single-cell transcriptomics, Biology (General), QH301-705.5
Abstract

Background and aims: Monocyte recruitment in the lamina propria and inflammatory phenotype driven by the mucosal microenvironment is critical for the pathogenesis of inflammatory bowel disease. However, the stimuli responsible remain largely unknown. Recent works have focused on stromal cells, the main steady-state cellular component in tissue, as they produce pro-inflammatory chemokines that contribute to the treatment-resistant nature of IBD. Methods: We studied the regulation of these processes by examining the communication patterns between stromal and myeloid cells in ileal Crohn’s disease (CD) using a complete single-cell whole tissue sequencing analysis pipeline and in vitro experimentation in mesenchymal cells. Results: We report expansion of S4 stromal cells and monocyte-like inflammatory macrophages in the inflamed mucosa and describe interactions that may establish sustained local inflammation. These include expression of CCL2 by S1 fibroblasts to recruit and retain monocytes and macrophages in the mucosa, where they receive signals for proliferation, survival, and differentiation to inflammatory macrophages from S4 stromal cells through molecules such as MIF, IFNγ, and FN1. The overexpression of CCL2 in ileal CD and its stromal origin was further demonstrated in vitro by cultured mesenchymal cells and intestinal organoids in the context of an inflammatory milieu. Conclusions: Our findings outline an extensive cross-talk between stromal and myeloid cells, which may contribute to the onset and progression of inflammation in ileal Crohn’s disease. Understanding the mechanisms underlying monocyte recruitment and polarization, as well as the role of stromal cells in sustaining inflammation, can provide new avenues for developing targeted therapies to treat IBD.

Published
2024
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23. Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer: The Primary Results of the PRONOUNCE Randomized Trial

Author

Lopes, Renato D, Higano, Celestia S, Slovin, Susan F, Nelson, Adam J, Bigelow, Robert, Sørensen, Per S, Melloni, Chiara, Goodman, Shaun G, Evans, Christopher P, Nilsson, Jan, Bhatt, Deepak L, Clarke, Noel W, Olesen, Tine K, Doyle-Olsen, Belinda T, Kristensen, Henriette, Arney, Lauren, Roe, Matthew T, Alexander, John H, Mol-Arts, Mirjam, Mansor-Lefebvre, Samreen, Zubovskiy, Konstantin, Blemings, Allan, Dugi, Klaus, Bloomfield, Gerald, Kontos, Chris, DeVore, Adam, Jordan, Dedrick, Kolls, Bradley, Matthews, Robin, Mehta, Rajendra, Povsic, Thomas J, Morse, Michael, Mahaffey, Kenneth W, Halabi, Susan, Leong, Darryl, Klotz, Laurence, Fleshner, Neil, Jansz, Godfrey, Giddens, Jonathan, Egerdie, Russell, Chin, Joseph, Zadra, Joseph, Casey, Richard, Simard, Jean, Niazi, Tamim, Martin, André-Guy, Babjuk, Marek, Hajek, Jaroslav, Klecka, Jiri, Kubes, Jiri, Schraml, Jan, Jakesova, Jitka, Vanasek, Jaroslav, Melichar, Bohuslav, Seikkula, Heikki, Abdiche, Manouar Samir, Colombel, Marc, Debourdeau, Philippe, Robert, Gregoire, Villers, Arnauld, Ploussard, Guillaume, Pradere, Benjamin, Bruyere, Franck, Descotes, Jean-Luc, Ouzaid, Idir, Winter, Alexander, Hanitzsch, Herbert, Sperling, Herbert, Eckert, Ralf, Hammerer, Peter, Stagge, Elke, Seseke, Florian, Szymula, Silvio, Bamias, Aristotelis, Thanos, Anastasios, Hatzimouratidis, Konstantinos, Mamoulakis, Charalambos, Kalofonos, Haralabos, Oszukowska, Elzbieta, Madziarska, Katarzyna, Fijuth, Jacek, Obarzanowski, Mateusz, Alekseev, Boris, Atduev, Vagif, Pushkar, Dmitri, Veliev, Evgeniy, Zyryanov, Alexander, Petrov, Sergey, Kopyltsov, Evgeny, Kozlov, Vadim, Macko, Ladislav, Dubravicky, Jozef, Polak, Richard, Mir, Obaidullah, Vargovcak, Marek, Mincik, Ivan, Kliment, Jan, Goncalves, Frederico, Mikulas, Juraj, and Sokol, Roman

Subjects
Cancer, Clinical Trials and Supportive Activities, Patient Safety, Aging, Prostate Cancer, Urologic Diseases, Cardiovascular, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Aged, Humans, Leuprolide, Male, Oligopeptides, Prospective Studies, Prostatic Neoplasms, agonists, atherosclerosis, cardiotoxicity, drug therapy, gonadotropin-releasing hormone, prostatic neoplasms, PRONOUNCE Study Investigators, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Public Health and Health Services, Cardiovascular System & Hematology
Abstract

BackgroundThe relative cardiovascular safety of gonadotropin-releasing hormone (GnRH) antagonists compared with GnRH agonists in men with prostate cancer and known atherosclerotic cardiovascular disease remains controversial.MethodsIn this international, multicenter, prospective, randomized, open-label trial, men with prostate cancer and concomitant atherosclerotic cardiovascular disease were randomly assigned 1:1 to receive the GnRH antagonist degarelix or the GnRH agonist leuprolide for 12 months. The primary outcome was the time to first adjudicated major adverse cardiovascular event (composite of death, myocardial infarction, or stroke) through 12 months.ResultsBecause of slower-than-projected enrollment and fewer-than-projected primary outcome events, enrollment was stopped before the 900 planned participants were accrued. From May 3, 2016, to April 16, 2020, a total of 545 patients from 113 sites across 12 countries were randomly selected. Baseline characteristics were balanced between study groups. The median age was 73 years, 49.8% had localized prostate cancer; 26.3% had locally advanced disease, and 20.4% had metastatic disease. A major adverse cardiovascular event occurred in 15 (5.5%) patients assigned to degarelix and 11 (4.1%) patients assigned to leuprolide (hazard ratio, 1.28 [95% CI, 0.59-2.79]; P=0.53).ConclusionsPRONOUNCE (A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease) is the first, international, randomized clinical trial to prospectively compare the cardiovascular safety of a GnRH antagonist and a GnRH agonist in patients with prostate cancer. The study was terminated prematurely because of the smaller than planned number of participants and events, and no difference in major adverse cardiovascular events at 1 year between patients assigned to degarelix or leuprolide was observed. The relative cardiovascular safety of GnRH antagonists and agonists remains unresolved. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02663908.

Published
2021

24. Immunomodulatory effects and improved outcomes with cisplatin- versus carboplatin-based chemotherapy plus atezolizumab in urothelial cancer

Author

Galsky, Matthew D., Guan, Xiangnan, Rishipathak, Deepali, Rapaport, Aaron S., Shehata, Hesham M., Banchereau, Romain, Yuen, Kobe, Varfolomeev, Eugene, Hu, Ruozhen, Han, Chia-Jung, Li, Haocheng, Liang, Yuxin, Vucic, Domagoj, Wang, Li, Zhu, Jun, Yu, Haocheng, Herbst, Rebecca H., Hajaj, Emma, Kiner, Evgeny, Bamias, Aristotelis, De Santis, Maria, Davis, Ian D., Arranz, José Ángel, Kikuchi, Eiji, Bernhard, Sandrine, Williams, Patrick, Lee, Chooi, Mellman, Ira, Sanjabi, Shomyseh, Johnston, Robert, Black, Peter C., Grande, Enrique, and Mariathasan, Sanjeev

Published
2024
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25. 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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26. Atezolizumab plus chemotherapy versus placebo plus chemotherapy in untreated locally advanced or metastatic urothelial carcinoma (IMvigor130): final overall survival analysis results from a randomised, controlled, phase 3 study

Author

Grande, Enrique, Arranz, José Á, De Santis, Maria, Bamias, Aristotelis, Kikuchi, Eiji, del Muro, Xavier Garcia, Park, Se Hoon, De Giorgi, Ugo, Alekseev, Boris, Mencinger, Marina, Izumi, Kouji, Schutz, Fabio A, Puente, Javier, Li, Jian-Ri, O'Donnell, Peter H, Kalebasty, Arash Rezazadeh, Ye, Dingwei, Mariathasan, Sanjeev, Bene-Tchaleu, FabioIa, Bernhard, Sandrine, Lee, Chooi, Davis, Ian D, and Galsky, Matthew D

Published
2024
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27. Atezolizumab monotherapy versus chemotherapy in untreated locally advanced or metastatic urothelial carcinoma (IMvigor130): final overall survival analysis from a randomised, controlled, phase 3 study

Author

Bamias, Aristotelis, Davis, Ian D, Galsky, Matthew D, Arranz, José Á, Kikuchi, Eiji, Grande, Enrique, del Muro, Xavier Garcia, Park, Se Hoon, De Giorgi, Ugo, Alekseev, Boris, Mencinger, Marina, Izumi, Kouji, Schutz, Fabio A, Puente, Javier, Li, Jian-Ri, Panni, Stefano, Gumus, Mahmut, Özgüroğlu, Mustafa, Mariathasan, Sanjeev, Poloz, Yekaterina, Bene-Tchaleu, Fabiola, Lee, Chooi, Bernhard, Sandrine, and De Santis, Maria

Published
2024
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28. Erdafitinib versus pembrolizumab in pretreated patients with advanced or metastatic urothelial cancer with select FGFR alterations: cohort 2 of the randomized phase III THOR trial

Author

Bastick, Patricia, Sewak, Sanjeev, Tran, Ben, Pichler, Martin, Shariat, Shahrokh, Rottey, Sylvie, Schatteman, Peter, Schrijvers, Dirk, Verschaeve, Vincent, Vulsteke, Christof, Barros Leite Ferreira, Luiza Aleixo, de Santana Gomes Andrea Juliana, Pereira, Junior, Joao Antonio, Azevedo, Sergio, Bastos, Diogo, Borges, Giuliano, Dettino, Aldo, Antonio, Pires Luis, Luz, Murilo, Martins, Suelen, Mota, Jose Mauricio, Toledo, Joseane, Eigl, Bernhard, Finch, Daygen, Gingerich, Joel, Dong, Haiying, Huang, Jian, Jin, Jie, Pan, Hongming, Sun, Zhongquan, Tian, Ye, Wan, Ben, Wu, Bin, Xu, Ting, Xue, Wei, Zhou, Fangjian, Barthelemy, Philippe, Borchiellini, Delphine, Calcagno, Fabien, Carnot, Aurelien, Cornillon, Pierre, Delva, Remy, Emambux, Sheik, Houede, Nadine, Laguerre, Brigitte, Lauridant, Géraldine, Loriot, Yohann, Mahammedi, Hakim, Maillet, Denis, Pouessel, Damien, Roubaud, Guilhem, Schlurmann-Constans, Friederike, Tosi, Diego, Zanetta, Sylvie, Banek, Severine, Feyerabend, Susan, Kramer, Mario, Niegisch, Guenther, Nuhn, Philipp, Schnabel, Marco, Wuelfing, Christian, Baka, Sofia, Bamias, Aristotelis, Fountzilas, George, Kalofonos, Harabolos, Karalis, Konstantinos, Kotsakis, Athanasios, Timotheadou, Eleni, Landherr, Laszlo, Mangel, Laszlo, Pe’er, Avivit, Levratovsky, Meital, Basso, Umberto, Battelli, Nicola, Cavo, Alessia, De Giorgi, Ugo, Doni, Laura, Galli, Luca, Gigante, Maria Olga, Guadalupi, Valentina, Maio, Michele, Milesi, Laura, Nolè, Franco, Scagliotti, Giorgio, Tortora, Giampaolo, Fukasawa, Satoshi, Harabayashi, Toru, Kamiya, Naoto, Kawahara, Takashi, Kawakita, Mutsushi, Matsubara, Nobunaki, Matsumoto, Kazumasa, Nishimura, Kazuo, Rikiya, Taoka, Shimizu, Nobuaki, Tagaki, Toshio, Kang, Taek Won, Kim, Jwa Hoon, Kim, SeHyun, Lee, Hyo Jin, Lee, Yun-Gyoo, Rha, Sun Young, Seo, Ho Kyung, Los, Maartje, Zurawski, Bogdan, Cortes, Paulo, Faustino, Catia, Vau, Nuno Sineiro, da Luz, Ricardo, Atduev, Vagif, Kirtbaya, Dmitry, Kopyltsov, Evgeny, Lykov, Aleksandr, Marat, Urmantsev, Orlov, Sergey, Penkov, Konstantin, Pirmagomedov, Albert, Semenov, Andrey, Varlamov, Sergey, Anguera, Georgia, Domenech, Montserrat, Girones, Regina, Gonzalez del Alba, Aranzazu, Milagro, Nuria Lainez, Luque, Raquel, Ortega, Esther Martínez, Mellado, Begoña, Méndez Vidal, María Jose, Fernandez, Esteban Nogales, Valderrama, Begoña Perez, Marín, Alvaro Pinto, Santander, Carmen, Huang, Yi-Hsiu, Su, Wen-Pin, Wu, Hung-Chan, Wu, WenJeng, Yu, Kai-Jie, Bilici, Ahmet, Goker, Erdem, Gumus, Mahmut, Karaoglu, Aziz, Kefeli, Umut, Köse, Fatih, Ozguroglu, Mustafa, Tural, Deniz, Turk, Haci, Yalcin, Suayib, Bondarenko, Igor, Khareba, Gennadii, Kidik, Yana, Lychkovskyy, Oleksandr, Sakalo, Valerii, Shevnia, Serghii, Stakhovskyy, Eduard, Bahl, Amit, Crabb, Simon, Powles, Thomas, Sankey, Peter, Sarwar, Mohammad, Benedetto, Pasquale, Burgess, Earle, Dawson, Nancy, Doshi, Gurjyot, Fleming, Mark, Maly, Joseph, Parikh, Mamta, Waterhouse, David, Siefker-Radtke, A.O., Matsubara, N., Park, S.H., Huddart, R.A., Burgess, E.F., Özgüroğlu, M., Valderrama, B.P., Laguerre, B., Basso, U., Triantos, S., Akapame, S., Kean, Y., Deprince, K., Mukhopadhyay, S., and Loriot, Y.

Published
2024
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29. A New Prognostic Model in Patients with Advanced Urothelial Carcinoma Treated with First-line Immune Checkpoint Inhibitors

Author

Khaki, Ali Raza, Li, Ang, Diamantopoulos, Leonidas N, Miller, Natalie J, Carril-Ajuria, Lucia, Castellano, Daniel, De Kouchkovsky, Ivan, Koshkin, Vadim, Park, Joseph, Alva, Ajjai, Bilen, Mehmet A, Stewart, Tyler, Santos, Victor, Agarwal, Neeraj, Jain, Jayanshu, Zakharia, Yousef, Morales-Barrera, Rafael, Devitt, Michael, Nelson, Ariel, Hoimes, Christopher J, Shreck, Evan, Gartrell, Benjamin A, Sankin, Alex, Tripathi, Abhishek, Zakopoulou, Roubini, Bamias, Aristotelis, Rodriguez-Vida, Alejo, Drakaki, Alexandra, Liu, Sandy, Kumar, Vivek, Lythgoe, Mark P, Pinato, David J, Murgic, Jure, Fröbe, Ana, Joshi, Monika, Isaacsson Velho, Pedro, Hahn, Noah, Alonso Buznego, Lucia, Duran, Ignacio, Moses, Marcus, Barata, Pedro, Galsky, Matthew D, Sonpavde, Guru, Yu, Evan Y, Shankaran, Veena, Lyman, Gary H, and Grivas, Petros

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Immunology, Clinical Research, Patient Safety, Cancer, Digestive Diseases, Prevention, Liver Disease, Aged, Carcinoma, Transitional Cell, Cohort Studies, Female, Humans, Immune Checkpoint Inhibitors, Prognosis, Retrospective Studies, Urinary Bladder Neoplasms, Bladder cancer, Immunotherapy, Outcome research, Prognostic model, Urothelial carcinoma, Clinical sciences, Oncology and carcinogenesis
Abstract

BackgroundWhile immune checkpoint inhibitors (ICIs) are approved in the first-line (1L) setting for cisplatin-unfit patients with programmed death-ligand 1 (PD-L1)-high tumors or for platinum (cisplatin/carboplatin)-unfit patients, response rates remain modest and outcomes vary with no clinically useful biomarkers (except for PD-L1).ObjectiveWe aimed to develop a prognostic model for overall survival (OS) in patients receiving 1L ICIs for advanced urothelial cancer (aUC) in a multicenter cohort study.Design, setting, and participantsPatients treated with 1L ICIs for aUC across 24 institutions and five countries (in the USA and Europe) outside clinical trials were included in this study.Outcome measurements and statistical analysisWe used a stepwise, hypothesis-driven approach using clinician-selected covariates to develop a new risk score for patients receiving ICIs in the 1L setting. Demographics, clinicopathologic data, treatment patterns, and OS were collected uniformly. Univariate Cox regression was performed on 18 covariates hypothesized to be associated with OS based on published data. Variables were retained for multivariate analysis (MVA) if they correlated with OS (p < 0.2) and were included in the final model if p < 0.05 on MVA. Retained covariates were assigned points based on the beta coefficient to create a risk score. Stratified median OS and C-statistic were calculated.Results and limitationsAmong 984 patients, 357 with a mean age of 71 yr were included in the analysis, 27% were female, 68% had pure UC, and 13% had upper tract UC. Eastern Cooperative Oncology Group performance status ≥2, albumin 5, and liver metastases were significant prognostic factors on MVA and were included in the risk score. C index for new 1L risk score was 0.68 (95% confidence interval 0.65-0.71). Limitations include retrospective nature and lack of external validation.ConclusionsWe developed a new 1L ICI risk score for OS based on data from patients with aUC treated with ICIs in the USA and Europe outside of clinical trials. The score components highlight readily available factors related to tumor biology and treatment response. External validation is being pursued.Patient summaryWith multiple new treatments under development and approved for advanced urothelial carcinoma, it can be difficult to identify the best treatment sequence for each patient. The risk score may help inform treatment discussions and estimate outcomes in patients treated with first-line immune checkpoint inhibitors, while it can also impact clinical trial design and endpoints. TAKE  HOME MESSAGE: A new risk score was developed for advanced urothelial carcinoma treated with first-line immune checkpoint inhibitors. The score assigned Eastern Cooperative Oncology Group performance status ≥2, albumin 5, and liver metastases each one point, with a higher score being associated with worse overall survival.

Published
2021

30. Response and Outcomes of Maintenance Avelumab After Platinum-Based Chemotherapy (PBC) in Patients With Advanced Urothelial Carcinoma (aUC): “Real World” Experience

Author

Bakaloudi, Dimitra Rafailia, Talukder, Rafee, Lin, Genevieve Ihsiu, Makrakis, Dimitrios, Diamantopoulos, Leonidas N., Tripathi, Nishita, Agarwal, Neeraj, Zakopoulou, Roubini, Bamias, Aristotelis, Brown, Jason R., Pinato, David J., Korolewicz, James, Jindal, Tanya, Koshkin, Vadim S., Murgić, Jure, Miletić, Marija, Frobe, Ana, Johnson, Jeffrey, Zakharia, Yousef, Drakaki, Alexandra, Rodriguez-Vida, Alejo, Rey-Cárdenas, Macarena, Castellano, Daniel, Buznego, Lucia Alonso, Duran, Ignacio, Carballeira, Clara Castro, Barrera, Rafael Morales, Marmorejo, David, McKay, Rana R., Stewart, Tyler, Gupta, Shilpa, Ruplin, Andrew Thomas, Yu, Evan Y., Khaki, Ali R., and Grivas, Petros

Published
2023
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31. Definition and Diagnosis of Oligometastatic Bladder Cancer: A Delphi Consensus Study Endorsed by the European Association of Urology, European Society for Radiotherapy and Oncology, and European Society of Medical Oncology Genitourinary Faculty

Author

Bamias, Aristotelis, Stenzl, Arnulf, Brown, Stephanie L., Albiges, Laurence, Babjuk, Marko, Birtle, Alison, Briganti, Alberto, Burger, Maximilian, Choudhury, Ananya, Colecchia, Maurizio, De Santis, Maria, Fanti, Stefano, Fonteyne, Valérie, Gallucci, Michele, Rivas, Juan Gómez, Huddart, Robert, Junker, Kerstin, Kroeze, Stephanie, Loriot, Yohann, Merseburger, Axel, Montironi, Rodolfo, Necchi, Andrea, Oing, Christoph, Oldenburg, Jan, Ost, Piet, Pinkawa, Michael, Ribal, Maria J., Rouprêt, Morgan, Thoeny, Harriet, Zilli, Thomas, and Hoskin, Peter

Published
2023
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33. Insights into Therapeutic Response Prediction for Ustekinumab in Ulcerative Colitis Using an Ensemble Bioinformatics Approach

Author

Kanellos Koustenis, Nikolas Dovrolis, Nikos Viazis, Alexandros Ioannou, Giorgos Bamias, George Karamanolis, and Maria Gazouli

Subjects
ulcerative colitis, ustekinumab, bioinformatics, prognostic markers, Biology (General), QH301-705.5, Chemistry, QD1-999
Abstract

Introduction: Optimizing treatment with biological agents is an ideal goal for patients with ulcerative colitis (UC). Recent data suggest that mucosal inflammation patterns and serum cytokine profiles differ between patients who respond and those who do not. Ustekinumab, a monoclonal antibody targeting the p40 subunit of interleukin (IL)-12 and IL-23, has shown promise, but predicting treatment response remains a challenge. We aimed to identify prognostic markers of response to ustekinumab in patients with active UC, utilizing information from their mucosal transcriptome. Methods: We performed a prospective observational study of 36 UC patients initiating treatment with ustekinumab. Colonic mucosal biopsies were obtained before treatment initiation for a gene expression analysis using a microarray panel of 84 inflammatory genes. A differential gene expression analysis (DGEA), correlation analysis, and network centrality analysis on co-expression networks were performed to identify potential biomarkers. Additionally, machine learning (ML) models were employed to predict treatment response based on gene expression data. Results: Seven genes, including BCL6, CXCL5, and FASLG, were significantly upregulated, while IL23A and IL23R were downregulated in non-responders compared to responders. The co-expression analysis revealed distinct patterns between responders and non-responders, with key genes like BCL6 and CRP highlighted in responders and CCL11 and CCL22 in non-responders. The ML algorithms demonstrated a high predictive power, emphasizing the significance of the IL23R, IL23A, and BCL6 genes. Conclusions: Our study identifies potential biomarkers associated with ustekinumab response in UC patients, shedding light on its underlying mechanisms and variability in treatment outcomes. Integrating transcriptomic approaches, including gene expression analyses and ML, offers valuable insights for personalized treatment strategies and highlights avenues for further research to enhance therapeutic outcomes for patients with UC.

Published
2024
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34. Current role of PSMA-PET imaging in the clinical management of prostate cancer

Author

Alexander Georgakopoulos, Aristotle Bamias, and Sophia Chatziioannou

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Despite the developments of the last few years, metastatic castration-resistant prostate cancer (PC) remains a deadly disease. Until recently, almost all guidelines recommended magnetic resonance imaging (MRI) or computed tomography (CT) for the initial staging and local/systematic recurrence. Positron emission tomography/computed tomography (PET/CT) with prostate-specific membrane antigen (PSMA) at the present stage, emerged as a promising diagnostic imaging tool for PC. PSMA PET/CT alone or in combination with multiparametric magnetic resonance imaging (mpMRI) can improve the detection of clinically significant PC, especially for Prostate Imaging Reporting & Data System (PI-RADS) = 3 lesions. In addition, PSMA PET/CT is more accurate than CT and bone scan for intermediate to high-risk disease at the initial staging. Contrariwise, a negative PET is not useful for surgeons to avoid a pelvic nodal dissection. PET-PSMA imaging is appropriate for prostate-specific antigen (PSA) persistence or PSA rise from undetectable level after radical prostatectomy or for PSA rise above nadir after definitive radiotherapy. Also, it is recommended for patients fit for curative salvage treatment. It should be noted that in patients, candidates for radionuclide therapy with Lutetium-177 ( 117 Lu), a PSMA strong expression from PET/CT at baseline is considered necessary. This review summarizes the evolution of PSMA PET/CT and its current role in the management of PC.

Published
2023
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35. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): overall survival and updated results of a randomised, double-blind, phase 3 trial.

Author

Petrylak, Daniel, de Wit, Ronald, Chi, Kim, Drakaki, Alexandra, Sternberg, Cora, Nishiyama, Hiroyuki, Castellano, Daniel, Hussain, Syed, Fléchon, Aude, Bamias, Aristotelis, Yu, Evan, van der Heijden, Michiel, Matsubara, Nobuaki, Alekseev, Boris, Necchi, Andrea, Géczi, Lajos, Ou, Yen-Chuan, Coskun, Hasan, Su, Wen-Pin, Bedke, Jens, Gakis, Georgios, Percent, Ivor, Lee, Jae-Lyun, Tucci, Marcello, Semenov, Andrey, Laestadius, Fredrik, Peer, Avivit, Tortora, Giampaolo, Safina, Sufia, Garcia Del Muro, Xavier, Rodriguez-Vida, Alejo, Cicin, Irfan, Harputluoglu, Hakan, Tagawa, Scott, Vaishampayan, Ulka, Aragon-Ching, Jeanny, Hamid, Oday, Liepa, Astra, Wijayawardana, Sameera, Russo, Francesca, Walgren, Richard, Zimmermann, Annamaria, Hozak, Rebecca, Bell-McGuinn, Katherine, and Powles, Thomas

Subjects
Aged, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Transitional Cell, Docetaxel, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle Aged, Neoplasm Invasiveness, Neoplasm Metastasis, Platinum, Prognosis, Salvage Therapy, Survival Rate, Urologic Neoplasms, Ramucirumab
Abstract

BACKGROUND: Ramucirumab-an IgG1 vascular endothelial growth factor receptor 2 antagonist-plus docetaxel was previously reported to improve progression-free survival in platinum-refractory, advanced urothelial carcinoma. Here, we report the secondary endpoint of overall survival results for the RANGE trial. METHODS: We did a randomised, double-blind, phase 3 trial in patients with advanced or metastatic urothelial carcinoma who progressed during or after platinum-based chemotherapy. Patients were enrolled from 124 investigative sites (hospitals, clinics, and academic centres) in 23 countries. Previous treatment with one immune checkpoint inhibitor was permitted. Patients were randomly assigned (1:1) using an interactive web response system to receive intravenous ramucirumab 10 mg/kg or placebo 10 mg/kg volume equivalent followed by intravenous docetaxel 75 mg/m2 (60 mg/m2 in Korea, Taiwan, and Japan) on day 1 of a 21-day cycle. Treatment continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met. Randomisation was stratified by geographical region, Eastern Cooperative Oncology Group performance status at baseline, and visceral metastasis. Progression-free survival (the primary endpoint) and overall survival (a key secondary endpoint) were assessed in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT02426125; patient enrolment is complete and the last patient on treatment is being followed up for safety issues. FINDINGS: Between July 20, 2015, and April 4, 2017, 530 patients were randomly allocated to ramucirumab plus docetaxel (n=263) or placebo plus docetaxel (n=267) and comprised the intention-to-treat population. At database lock (March 21, 2018) for the final overall survival analysis, median follow-up was 7·4 months (IQR 3·5-13·9). In our sensitivity analysis of investigator-assessed progression-free survival at the overall survival database lock, median progression-free survival remained significantly improved with ramucirumab compared with placebo (4·1 months [95% CI 3·3-4·8] vs 2·8 months [2·6-2·9]; HR 0·696 [95% CI 0·573-0·845]; p=0·0002). Median overall survival was 9·4 months (95% CI 7·9-11·4) in the ramucirumab group versus 7·9 months (7·0-9·3) in the placebo group (stratified HR 0·887 [95% CI 0·724-1·086]; p=0·25). Grade 3 or worse treatment-related treatment-emergent adverse events in 5% or more of patients and with an incidence more than 2% higher with ramucirumab than with placebo were febrile neutropenia (24 [9%] of 258 patients in the ramucirumab group vs 16 [6%] of 265 patients in the placebo group) and neutropenia (17 [7%] of 258 vs six [2%] of 265). Serious adverse events were similar between groups (112 [43%] of 258 patients in the ramucirumab group vs 107 [40%] of 265 patients in the placebo group). Adverse events related to study treatment and leading to death occurred in eight (3%) patients in the ramucirumab group versus five (2%) patients in the placebo group. INTERPRETATION: Additional follow-up supports that ramucirumab plus docetaxel significantly improves progression-free survival, without a significant improvement in overall survival, for patients with platinum-refractory advanced urothelial carcinoma. Clinically meaningful benefit might be restricted in an unselected population. FUNDING: Eli Lilly and Company.

Published
2020

36. Treatment Rechallenge With Immune Checkpoint Inhibitors in Advanced Urothelial Carcinoma

Author

Makrakis, Dimitrios, Bakaloudi, Dimitra Rafailia, Talukder, Rafee, Lin, Genevieve Ihsiu, Diamantopoulos, Leonidas N., Jindal, Tanya, Vather-Wu, Naomi, Zakharia, Yousef, Tripathi, Nishita, Agarwal, Neeraj, Dawsey, Scott, Gupta, Shilpa, Lu, Eric, Drakaki, Alexandra, Liu, Sandy, Zakopoulou, Roubini, Bamias, Aristotelis, Fulgenzi, Claudia-Maria, Cortellini, Alessio, Pinato, David, Barata, Pedro, Grivas, Petros, Khaki, Ali Raza, and Koshkin, Vadim S.

Published
2023
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37. Patient-reported Outcomes from JAVELIN Bladder 100: Avelumab First-line Maintenance Plus Best Supportive Care Versus Best Supportive Care Alone for Advanced Urothelial Carcinoma

Author

Grivas, Petros, Kopyltsov, Evgeny, Su, Po-Jung, Parnis, Francis X., Park, Se Hoon, Yamamoto, Yoshiaki, Fong, Peter C., Tournigand, Christophe, Climent Duran, Miguel A., Bamias, Aristotelis, Caserta, Claudia, Chang, Jane, Cislo, Paul, di Pietro, Alessandra, Wang, Jing, and Powles, Thomas

Published
2023
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38. I-CARE, a European Prospective Cohort Study Assessing Safety and Effectiveness of Biologics in Inflammatory Bowel Disease

Author

Gornet, Jean-Marc, Beaugerie, Laurent, Shaji, Sebastian, Peyrin-Biroulet, Laurent, Reimund, Jean-Marie, Hebuterne, Xavier, Amiot, Aurélien, Armelao, Franco, Blanc, Pierre, Papi, Claudio, De Chambrun, Guillaume Pineton, Roblin, Xavier, Chu, Karmiris, Konstantinos, Shariq, Sohail, Viazis, Nikolaos, Limdi, Jimmy, Eder H, Piotr, Michalopoulos, Georgios, Bell, Andrew, Biancone, Livia, Dewitte, Marie, Mazhar, Zia, Franchimont, Denis, Nancey, Stephane, Macaigne, Gilles, Principi, Maria Beatrice, Fumery, Mathurin, Parkes, Gareth, Valats, Jean-Christophe, Doherty, Glen, Bouguen, Guillaume, Molnar, Tamás, Tsai, Hersin, Gangi, Mohsin, Pedersen, Natalia, Heluwaert, Frédéric, Shenderey, Richard, Zeissig, Sebastian, Butterworth, Jeffrey, Castiglione, Fabiana, Corless, Lynsey, Zallot, Camille, Baert, Filip, Singh, Salil, Sonwalkar, Sunil, Clayton, Elizabeth, Rahier, Jean-François, Vani, Deven, Bellaiche, Guy, De Vos, Martine, Kirchgesner, Julien, Kopylov, Uri, Lobaton, Triana, Locher, Christophe, Mantzaris, Gerassimos, Abouda, George, Smith, Katie, Sprakes, Michael, Theodoropoulou, Angeliki, Wesley, Emma, Bonnet, Joëlle, Elphick, David, Gilletta, Cyrielle, Gordon, John, Laharie, David, Nakad, Antoine, Orlando, Ambrogio, Dubois, Patrick, Hasselblatt, Peter, Michiels, Christophe, Preston, Cathryn, Staicu, Anca, Vuitton, Lucine, Kaassis, Mehdi, Speight, Ally, Ghosh, Deb, Löwenberg, Mark, Mathieu, Nicolas, Pelletier, Anne-Laure, Phillips, Anne, Magro, Fernando, Altwegg, Romain, Avni, Irit, biron, Landy, Jonathon, Nachury, Maria, Shenoy, Achuth, Trang, Caroline, Abitbol, Vered, Bamias, Georgios, Farkas, Klaudia, Maaser, Christian, Shitrit, Ariella, Siegmund, Britta, Filippi, Jérôme, O'morain, Colm, Yanai, Henit, Costes, Laurent, Hobday, David, Szepes, Zoltán, Calabrese, Emma, Dallal, Helen, Fung, Michael, Ramadas, Arvind, Baburajan, Bijay, Koss, Konrad, Barberis, Christophe, Buisson, Anthony, Amil, Morgane, Balestrieri, Paola, Johnson, Matthew, Tzouvala, Maria, Viennot, Stéphanie, Nagy, Ferenc, Thompson, Nick, Alric, Laurent, Samuel, Sunil, Bourrier, Anne, Chanteloup, Elise, Del Tedesco, Emilie, Harbord, Marcus, Lobo, Alan, Myers, Sally, Pollok, Richard, Ahmad, Tariq, Chaudhary, Rakesh, Karakoidas, Christos, Soliman, Ashraf, Stefanescu, Carmen, Theocharis, Georgios, Branden, Stijn Vanden, Beltran, Belén, Bouhnik, Yoram, Bourreille, Arnaud, Branco, Joana, Colleypriest, Ben, Eliakim, Rami, Knight, Paul, O'toole, Aoibhlinn, Robles, Virgina, Triantafyllou, Konstantinos, Bosca, Marta Maia, Lambrecht, Guy, Mosquera, Lucia Marquez, Panter, Simon, Pappa, Aikaterini, Simon, Marion, Sivaji, Ganesh, Bellanger, Christophe, Belle, Arthur, Borruel, Natalia, Egan, Laurence, Peeters, Harald, Sharpstone, Daniel, Arasaradnam, Ramesh, Benitez, José Manuel, Dahlerup, Jens Frederik, Giouleme, Olga, Gisbert, Javier P., Helwig, Ulf, Minguez, Miguel, Tsironi, Eftychia, Variola, Angela, Allen, Patrick, Boivineau, Lucille, Cole, Andy, Dib, Nina, Gomollon, Fernando, Johnston, Richard, Katsanos, Konstantinos, Kennedy, Nick, Kiszka-Kanowitz, Marianne, Marin-Jimenez, Ignacio, Miheller, Pál, Nos, Pilar, Saraj, Othman, Vinter-Jensen, Lars, Zittan, Eran, Baudry, Clotilde, Calvet, Xavier, Cazelles-Boudier, Marie-Christine, Coenegrachts, Jean-Louis, Cullen, Garret, Daperno, Marco, Dhar, Anjan, Gerard, Romain, Jensen, Nanna, Maharshak, Nitsan, Mcalindon, Mark, Mcloughlin, Simon, Parkes, Miles, Patel, Kamal, Peixoto, Armando, Polymeros, Dimitrios, Portela, Francisco, Rocca, Rodolfo, Seksik, Philippe, Subramanian, Sreedhar, Tennenbaum, Ruth, Atreya, Raja, Bachmann, Oliver, Berger, Arthur, Bor, Renáta, Buckley, Maire, Carpio, Daniel, Chaparro, María, Costa, Francesco, Domenech, Eugeni, Esteve, Maria, Foley, Stephen, Guardiola, Jordi, Koutroubakis, Ioannis, Kuehbacher, Tanja, Landman, Cécilia, Lavagna, Alessandro, Manceñido, Noemí, Mañosa, Míriam, Martín-Arranz, Maria Dolores, Plastaras, Laurianne, Scribano, Maria Lia, Sengupta, Subhasish, Teich, Nils, Tran-Minh, My-Linh, Zampeli, Evanthia, Amininejad, Leila, Arroyo, Teresa, Attar, Alain, Backman, Ann-Sofie, Bálint, Anita, Beckly, John, Ben Horin, Shomron, Bernardo, Sónia, Caillo, Ludovic, Caron, Bénédicte, Shanika de Silva, María, FábiáN, Anna, Fiorino, Gionata, Gutierrez, Ana, Lahat, Adi, Masmoudi, Mohamed, Mendolaro, Marco, Muls, Vinciane, Poullenot, Florian, Probert, Christopher, Reenaers, Catherine, Rutka, Mariann, Sarwari, Zaman, Sayer, Joanne, Sicilia, Beatriz, Sousa, Helena, van Kemseke, Catherine, Zabana, Yamile, Astegiano, Marco, Banim, Paul, Bettenworth, Dominik, Boualit, Médina, Brodersen, Jacob Broder, Christidou, Angeliki, Cooney, Rachel, Pinto, João Cortez, Cravo, Portugal Marília, Cremer, Anneline, Danese, Silvio, di Sabatino, Antonio, Fallingborg, Jan, Ferronato, Antonio, Planella, Esther Garcia, Gupta, Sanjay, Halfvarson, Jonas, Israeli, Eran, Kestenbaum, Samantha, Larsen, Lone, Macken, Elisabeth, Mathou, Nicoletta, Milassin, Ágnes, Pofelski, Joanna, Ricci, Chiara, Rodriguez-Moranta, Francisco, Schmidt-Lauber, Martin, Shaw, Ian, Soares, Marta, Soliman, Heithem, Triantos, Christos, Zografos, Konstantinos, Agrawal, Anurag, Armuzzi, Alessandro, Aubourg, Alexandre, Acosta, Manuel Barreiro-de, Barrio, Jesús, Bergemalm, Daniel, Bermejo, Fernando, Bodini, Giorgia, Bohr, Johan, Bossuyt, Peter, Christodoulou, Dimitrios, Claessens, Christophe, Collins, Paul, de Francisco, Ruth, Garcia, Santiago, Georgopoulos, Sotirios, Goutorbe, Felix, Kalantzis, Chrisostomos, Kourikou, Anastasia, Mace, Vincent, Malamut, Georgia, Ministro, Paula, Larmurier, Isabelle Nion, Ricart, Elena, Serrero, Mélanie, Sheridan, Juliette, Weimers, Petra, Andersen, Vibeke, Arroja, Bruno, Bokemeyer, Bernd, Bujanda, Luis, Degand, Thibault, Eriksson, Carl, Garceau, Cécile, Glerup, Henning, Goren, Idan, Jackson, Lucina, Koch, Stéphane, Mesonero, Francisco, Ordas, Ingrid, Riviere, Pauline, Saibeni, Simone, Soares, João, Tavernier, Noémie, Theede, Klaus, Ungar, Bella, Bästlein, Elke, Gasbarrini, Antonio, Protopapas, Andreas, Reindl, Wolfgang, Bossa, Fabrizio, Hart, Ailsa, Heil, Franz-Josef, O'Connor, Anthony, Oldenburg, Bas, Pastorelli, Luca, Stephen patchett, Ramakrishnan, Subramaniam, de Caestecker, John, Echarri, Ana, Kevans, David, Büning, Jürgen, Coelho, Rosa, Jansen, Jeroen, Koslowski, Benjamin, Wells, Christopher, Ceballos, Daniel, König, Ingrid, Padmanabhan, Hari, Patani, Timi, Qureshi, Raheel, Zagorowicz, Edyta, Allez, Matthieu, Archavlis, Emmanouil, Bonnet, Delphine, Guidi, Luisa, Mcnamara, Deirdre, Vernia, Piero, Weidenhiller, Michael, Alon, Lang, Boysen, Trine, Delattre, Charlotte, Farrell, Richard, Krüger, Rolf-Achim, Paupard, Thierry, Vind, Ida, Caprioli, Flavio, Gancho, Vladimir, Quentin, Vincent, Avidan, Benjamin, D’Haens, Geert, Mccarthy, Jane, Snook, Jonathon, Soufleris, Konstantinos, Zerbib, Frank, Carter, Dan, Depla, Annekatrien, Eisenbach, Thomas, Fries, Walter, Grammatikos, Nikolaos, Ilegems, Saskia, Lopez-Sanroman, Antonio, Moreau, Jacques, Riegler, Gabriele, Rietdijk, Svend, Rocha, Marta, Rosa, Isabelle, Ryan, Barbara, Yeremenko, Yelena, Boruchowicz, Arnaud, Damião, Filipe, Laoudi, Foteini, Lügering, Andreas, Macarri, Giampiero, Thomopoulos, Konstantinos, Barros, Luísa, Blixt, Thomas, Garros, Aurélien, Khorrami, Sam, Sokol, Harry, Sturm, Andreas, Livovsky, Dan, Maul, Jochen, Miks, Heinrich, Papadopoulos, Vasileios, Schmidt, Carsten, Snir, Yifat, Svenningsen, Lise, Ahmed, Wafaa, Broitman, Yelena, Cuillerier, Emmanuel, Kant, Prashant, Leyden, Jan, Lichtenstein, Lev, Lopes, Susana, Martineau, Chloé, Mulcahy, Hugh, Schweitzer, Axel, Van Schaik, Fiona, Banai, Hagar, Danion, Pauline, Dulery, Charlotte, Fidder, Herma, Gay, Claire, Hagege, Hervé, Harnois, Florence, Jørgensen, Søren Peter, Müller-Ziehm, Jens, Oikonomou, Michail, Palmela, Carolina, Schulze/Röske, Jörg, Smith, Mark, Thurm, Tamar, Bresso, Francesca, Brixi, Hedia, Jones, John, Macmathuna, Padraig, Painchart, Claire, Ron, Yulia, Vester-Andersen, Marianne, Alexandrino, Gonçalo, Börner, Norbert, Cardoso, Mariana, Chagas, Cristina, Dignaß, Axel, Dotan, Iris, Hedin, Charlotte, Karatzas, Pantelis, Kasapidis, Panagiotis, Palatka, Károly, Sakizlis, Georgios, Wilson, Ana, Bosanko, Nick, Caldeira, Paulo, Gagniere, Charlotte, Libier, Louise, Meunier, Camille, Moog, Gero, Pasquion, Audrey, Pica, Roberta, Akbar, Ayesha, Arab, Nadia, Cadiot, Guillaume, Carvalho, João, Charpignon, Claire, Fellermann, Laus, Fishman, Sigal, Fraser, Gerald, Gluck, Nathan, Hoesl, Mark, Kierkus, Jarosław, Klopocka, Maria, Arranz, Eduardo Martin, Menchen, Luis, Nikolaus, Susanna, Petrache, Anca, Ponsioen, Cyriel, Riestra, Sabino, Robledo, Pilar, Rodriguez, Cristina, Samer, Misheal, Tischer, Matthias, Wypych, Joanna, Baudon, Julien, Bezzio, Cristina, Boschetti, Gilles, Burisch, Johan, Creed, Tom, Demarzo, Maria Giulia, Festa, Stefano, Figueroa, Andrés, Julsgaard, Mette, Navarro, Pablo, Perez-Galindo, Pablo, Rouillon, Cléa, Sablich, Emanuele, Tosca, Joan, Vidon, Mathias, Vidon, Marine, Vitte, René-Louis, Wampach, Anne, Baumann, Cédric, Urmes, Isabelle Clerc, Rousseau, Hélène, Borie, Marc, Uzzan, Mathieu, Chatten, Kelly, Peter, Rimmer, Tariq, Iqbal, Cossignani, Marta, Cañete, Fiorella, Holvoet, Tom, Krasz, Susanne, Dias, Sandra, Abalia, Hadas, Abaza, Aziza, Abramovich, Gal, Ackzell, Ingrid, Adams, Carol, Addleton, Catherine, Alfambra, Erika, Algaba, Alicia, Allcock, Clare, Allison, Joanna, Amouriaux, Karine, Anderson, Julie, Anderson, Emma, Appelmans, Saskia, Armstrong, Lisa, Atkins, Stacey, Attaran-Bandarabadi, Masoumeh, Bailey, Yvonne, Bardot, Stephanie, Beck, Natasha, Bennett, Lillie, Bergfeld, Jonathan Phil, Berkane, Ramdane, Boey, Hanne, Bowlas, Louise, Bradley-Potts, Joanne, Brear, Tracy, Bretlander-Peters, Nicole, Brown, Ellen, Brown, Johanna, Buckingham, Elizabeth, Buellens, Katrien, Bull, Rhian, Burke, Maura, Burns, Leighanne, Burton, Julie, Bwalya, Agness, Cabanas, Karine, Callaghan, Muriel, Camou, Océane, Campbell, Debbie, Capoferro, Elvira, Carnahan, Mandy, Carnio, Cornelia, Carter, Anne, Clack, Concetta Casali, Chedouba, Leïla, Cipriano, Bessie, Claeys, Sophie, Closset, Manon, Coban, Dilek, Cococcia, Sara, Coe, Carolann, Cole, Helen, Collet, Emilie, Collins, Kayleigh, Combes, Isabelle, Connor, Emma, Constantin, Kathryn, Cooke, Susan, Cornet, Nathanaëlle, Corrihons, Estelle, Corsino, Pilar, Cortaville, Rosie, Cotterill, Donna, Cowton, Amanda, Cox, Harriet, Cripps, Viktoria, Crowder, Amanda, Cukier, Tzufit, Daniel, Amelia, Dawe, Chris, de Haan, Jose, Croix, Rosanna de la, Dejonckheere, Evva, Villanegro, Juan Delare, Delaval, Guillaume, Delliponti, Mariangela, Delommez, Aude, Detry, Emilie, Dhanaratne, Melanie, Galan, Laura Diez, Dodel, Marie, Dooks, Emma, Du Cheyron, Joseph, Duane, Linda, Vulgo Cochran, Jennifer Dulling, Dyer, Simona, Dymond, Harvey, Ekblad, Charlotte, Elliott, Kerry, Emmerson, Ingrid, Eugene-Jolchine, Irène, Fleming, Lorna, Fletcher, Eve, Ford, Sarah, Forshaw, Greg, Foulds, Angela, Francois, Caroline, Fuge, Nicole, Gafni, Gal, Ganon, Miri, Nuñez, Olga Garcia, Ramirez, Laura Garcia, Gelder, Sophie, Gettkowski, Raimonda, Gilardi, Daniela, Giuffrida, Paolo, Gobert, Vincent, Godden, Jo, Godwin, Nuala, Goulden, Kay, Graham, Sharon, Green, Charlotte, Green, Marie, Gueye, Aboubakar, Guler, Tuba, Gustavsson, Ida, Hadjisavvas, Helena, Hammonds, Fiona, Hantzi, Christina, Hauke, Marion, Haydock, Julie, Hayes, Orla, Nislev, Lizette Helbo, Hochstodter, Jessica, Hogg, Ashleigh, Hölbing, Manuela, Holland, Maureen, Holsbergen, Maartje, Howard, Linda, Hoyda, Aviya, Hull, Robert, Irish, Jane, Jackson, Wendy, Janssen, Wendy, Jeffrey, Lesley, Jourdan, Sofia, Jutrowska, Izabela, Kaniel, Chava, Karezos, Theofilos, Kelly, Niamh, Kelly, Jessica, Kennedy, Mary, Kennedy, Una, Kibaru, Joyce, Kirkman, Gemma, Klaproth, Janine, Kneese, Corinna, Koch, Andrea, Kokke, Kathleen, Koppelow, Martha, Krause, Sabine, Krauspe, Sabine, Kwakkenbos, Petra, Labarile, Nunzia, Lang, Hannah, Lassailly, Marianne, Leconte, Martine, Lepczynski, Linda, Levell, Emma, Levhar, Nina, Lindhort, Kerstin, Lisle, Jessica, Cauce, Beatriz Lopez, Lorenz, Gabriele, Lovati, Ambra, Lowry, Tracey, Lund, Margareta, Vorderbrügge, Anne Lutz, Maansson, Suzanne, Madapathage, Videsheka, Cheviakoff, Maelys, Magness, Alison, Manley, Orla, Manyoni, Catherine, Marg, Ingke, Marra, Antonella, Martins, Carole, Massella, Arianna, Mathias, Aurore, Mervyn, Danielle, Minsart, Charlotte, Mitchell, Sally, Monks, Kathleen, Montero, Mélanie, Moore, Alson, Moser, Maren, Moss, Alison, Mullen, Angela, Murciano, M. Francisca, Naylor, Deanna, Nehus, Ansgar, Nicholson, Anne, Nöding, Sarah, Nolan, Sinead, Nörenberg, Janet, Northcott, Clare, O'Connell, Jim, O’Kelly, Alison, Orbach-Zingboim, Noam, Orobitg, Judit, Otieno, Charlene, Owen, Charlotte, Patch, Sarah, Pauker, Maor, Pauli, Renate, Pearson, Harriet, Peggy, Falgon, Petit, Séverine, Petrissans, Christine, Piergallini, Simona, Pippard, Lucy, Pitt, Laura, Pócsik, Gabriella, Poher, Yoann, Pomes, Chloé, Pritchard, Lucy, Puchades, Laura, Quaid, Sheena, Rana, Aleem, Raynard, Dana, Reilly, Mykla, Reinert, Sonja, Reinknecht, Manuela, Renner, Baerbel, Reynolds, Rob, Rizzuto, Giulia, Robinson, Matthew, Robrechts, Joke, Rodriguez, Eva M., Rosenblum, Efrat, Russel, Tamlyn, Sadare, Ibiyemi, Salama, Noa, Schakel, Toos, Schauer, Anja, Schiavoni, Elisa, Shaw, Caroline, Shelton, Sarah, Sicart, Virginie, Siouville, Elodie, Smith, Orla, Soude, Théo, Stephenson, Sophie, Stephenson, Elaine, Steppe, Marjan, Sterkx, An, Stickley, Jo, Sugrue, Kathleen, Swietec, Natalia, Tasiaux, Charlotte, Thamu, Bhavneet, Thomas, Susane, Tobi, Ogwa, Touabi, Kahina, Tovi, Shifra, Tregonning, Julie, Turchini, Laura, Unkhoff, Julia, Unruh, Olesya, Uzun, Nurcan, Van Aert, Frauke, Bergh, Sandrine Vanden, Vandenbroucke, Louise, Vansteenkiste, Laura, Vardit, Shay, Vergriete, Valentin, Walker, Elaine, Warner, Eleanor, Watchorn, Olivia, Watson, Ekaterina, Wauthier, Marie-Claire, Weetman, Belgium Maria, Weston, Margaret, West-Petroschka, Wiebke, Wienecke, Susann, Wierling, Kerstin, Wiestler, Miriam, Wilcox, Rebecca, Wilhelmsen, Elva, Williams, Angharad, Williamson, Georgina, Wilson, Deborah, Wistance, Kate, Wortmann, Nicolas, Wurie, Subie, Yadgar, Karin, Young, Gail, Young, Megan, Aucouturier, Julien, Bertin, Marie- Jo, Bougrine, Hasnae, Coisnon, Marie, Defrance, Antoine, Gutierrez, Kati, Harouz, Amel, Jerber, Laure, Khlifi, Aida, Kirati, Amina, Liworo, Nasaladjine, Logoltat, Maude, Mailhat, Charlotte, M'Bayi, Chancely, Medane, Yasmina, Merkhoufa, Dalal, Elhad, Saouda Mohamed, Monthe, Bertille, Moyon, Fanny, Rabiega, Pascaline, Sekela, Jennifer, Thilloy, Charlotte, Hamamouche, Naima, Partisotti, Frederic, Blandin, Patrick, Mokhtari, Hocine, Coutard, Laure, and Doherty, Glen A.

Published
2023
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40. Characterization of complete responders to nivolumab + gemcitabine-cisplatin vs gemcitabine-cisplatin alone and patients with lymph node–only metastatic urothelial carcinoma from the CheckMate 901 trial.

Author

Galsky, Matt D., primary, Sonpavde, Guru P., additional, Powles, Thomas, additional, Claps, Melanie, additional, Burotto, Mauricio, additional, Schenker, Michael, additional, Sade, Juan Pablo, additional, Bamias, Aristotelis, additional, Beuzeboc, Philippe, additional, Bedke, Jens, additional, Oldenburg, Jan, additional, Ürün, Yüksel, additional, Ye, Ding-Wei, additional, Valderrama, Begoña Pérez, additional, Tomita, Yoshihiko, additional, Filian, Jeiry, additional, Wang, Lily, additional, Purcea, Daniela, additional, and Van Der Heijden, Michiel Simon, additional

Published
2024
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41. Final Results from SAUL, a Single-arm International Study of Atezolizumab in Unselected Patients with Pretreated Locally Advanced/Metastatic Urinary Tract Carcinoma

Author

Sternberg, Cora N., primary, Loriot, Yohann, additional, Choy, Ernest, additional, Castellano, Daniel, additional, Lopez-Rios, Fernando, additional, Banna, Giuseppe Luigi, additional, Zengerling, Friedemann, additional, De Giorgi, Ugo, additional, Gedye, Craig, additional, Masini, Cristina, additional, Bamias, Aristotelis, additional, Garcia del Muro, Xavier, additional, Duran, Ignacio, additional, Powles, Thomas, additional, Retz, Margitta, additional, Gamulin, Marija, additional, Geczi, Lajos, additional, Huddart, Robert A., additional, Calabrò, Fabio, additional, Kandula, Geetha, additional, Skamnioti, Pari, additional, and Merseburger, Axel S., additional

Published
2024
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43. Carboplatin-based doublet plus bevacizumab beyond progression versus carboplatin-based doublet alone in patients with platinum-sensitive ovarian cancer: a randomised, phase 3 trial

Author

Pignata, S, Lorusso, D, Joly, F, Gallo, C, Colombo, N, Sessa, C, Bamias, A, Salutari, V, Selle, F, Frezzini, S, De Giorgi, U, Pautier, P, Bologna, A, Orditura, M, Dubot, C, Gadducci, A, Mammoliti, S, Ray-Coquard, I, Zafarana, E, Breda, E, Favier, L, Ardizzoia, A, Cinieri, S, Largillier, R, Sambataro, D, Guardiola, E, Lauria, R, Pisano, C, Raspagliesi, F, Scambia, G, Daniele, G, Perrone, F, Pignata, Sandro, Lorusso, Domenica, Joly, Florence, Gallo, Ciro, Colombo, Nicoletta, Sessa, Cristiana, Bamias, Aristotelis, Salutari, Vanda, Selle, Frédèric, Frezzini, Simona, De Giorgi, Ugo, Pautier, Patricia, Bologna, Alessandra, Orditura, Michele, Dubot, Coraline, Gadducci, Angiolo, Mammoliti, Serafina, Ray-Coquard, Isabelle, Zafarana, Elena, Breda, Enrico, Favier, Laure, Ardizzoia, Antonio, Cinieri, Saverio, Largillier, Rémy, Sambataro, Daniela, Guardiola, Emmanuel, Lauria, Rossella, Pisano, Carmela, Raspagliesi, Francesco, Scambia, Giovanni, Daniele, Gennaro, and Perrone, Francesco

Published
2021
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44. Prospective Observational Study of Pazopanib in Patients with Advanced Renal Cell Carcinoma (PRINCIPAL Study)

Author

Schmidinger, Manuela, Bamias, Aristotelis, Procopio, Giuseppe, Hawkins, Robert, Sanchez, Angel Rodriguez, Vázquez, Sergio, Srihari, Narayanan, Kalofonos, Haralabos, Bono, Petri, Pisal, Chaitali Babanrao, Hirschberg, Yulia, Dezzani, Luca, Ahmad, Qasim, Jonasch, Eric, and Group, on behalf of the PRINCIPAL Study

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Kidney Disease, Cancer, Patient Safety, Clinical Research, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, 6.2 Cellular and gene therapies, Evaluation of treatments and therapeutic interventions, Adult, Aged, Aged, 80 and over, Angiogenesis Inhibitors, Carcinoma, Renal Cell, Female, Follow-Up Studies, Humans, Indazoles, Kidney Neoplasms, Male, Middle Aged, Prognosis, Prospective Studies, Pyrimidines, Quality of Life, Sulfonamides, Survival Rate, Treatment Outcome, Young Adult, PRINCIPAL Study Group, Observational, Pazopanib, Real‐world, Renal cell carcinoma, Tyrosine kinase inhibitor, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundReal-world data are essential to accurately assessing efficacy and toxicity of approved agents in everyday practice. PRINCIPAL, a prospective, observational study, was designed to confirm the real-world safety and efficacy of pazopanib in patients with advanced renal cell carcinoma (RCC).Subjects, materials, and methodsPatients with clear cell advanced/metastatic RCC and a clinical decision to initiate pazopanib treatment within 30 days of enrollment were eligible. Primary objectives included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), relative dose intensity (RDI) and its effect on treatment outcomes, change in health-related quality of life (HRQoL), and safety. We also compared characteristics and outcomes of clinical-trial-eligible (CTE) patients, defined using COMPARZ trial eligibility criteria, with those of non-clinical-trial-eligible (NCTE) patients. Secondary study objectives were to evaluate clinical efficacy, safety, and RDI in patient subgroups.ResultsSix hundred fifty-seven patients were enrolled and received ≥1 dose of pazopanib. Median PFS and OS were 10.3 months (95% confidence interval [CI], 9.2-12.0) and 29.9 months (95% CI, 24.7 to not reached), respectively, and the ORR was 30.3%. HRQoL showed no or little deterioration over time. Treatment-related serious adverse events (AEs) and AEs of special interest occurred in 64 (9.7%), and 399 (60.7%) patients, respectively. More patients were classified NCTE than CTE (85.2% vs. 14.8%). Efficacy of pazopanib was similar between the two groups.ConclusionPRINCIPAL confirms the efficacy and safety of pazopanib in patients with advanced/metastatic RCC in a real-world clinical setting.Implications for practicePRINCIPAL is the largest (n = 657) prospective, observational study of pazopanib in patients with advanced/metastatic renal cell carcinoma, to the authors' knowledge. Consistent with clinical trial results that often contain specific patient types, the PRINCIPAL study demonstrated that the effectiveness and safety of pazopanib is similarly safe and effective in patients with advanced kidney cancer in a real-world clinical setting. The PRINCIPAL study showed that patients with advanced kidney cancer who are treated with first-line pazopanib generally do not show disease progression for approximately 10 months and generally survive for nearly 30 months.

Published
2019

45. Risk for Arterial Thromboembolic Events (ATEs) in Patients with Advanced Urinary Tract Cancer (aUTC) Treated with First-Line Chemotherapy: Single-Center, Observational Study

Author

Aristotelis Bamias, Kimon Tzannis, Roubini Zakopoulou, Minas Sakellakis, John Dimitriadis, Alkistis Papatheodoridi, Loukianos Rallidis, Panagiotis Halvatsiotis, Anna Tsiara, Maria Kaparelou, Efthymios Kostouros, Despina Barbarousi, Konstantinos Koutsoukos, Evangelos Fragiadis, Athanasios E. Dellis, Ioannis Anastasiou, Konstantinos Stravodimos, Alexandros Pinitas, Athanasios Papatsoris, Ioannis Adamakis, Ioannis Varkarakis, Charalampos Fragoulis, Stamatina Pagoni, Charis Matsouka, Andreas Skolarikos, Dionysios Mitropoulos, Konstantinos Doumas, Charalampos Deliveliotis, Constantinos Constantinides, and Meletios-Athanasios Dimopoulos

Subjects
arterial, thromboembolism, urinary tract, cancer, chemotherapy, observational, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Arterial thromboembolism has been associated with cancer or its treatment. Unlike venous thromboembolism, the incidence and risk factors have not been extensively studied. Here, we investigated the incidence of arterial thromboembolic events (ATEs) in an institutional series of advanced urinary tract cancer (aUTC) treated with cytotoxic chemotherapy. The ATE definition included peripheral arterial embolism/thrombosis, ischemic stroke and coronary events. A total of 354 aUTC patients were analyzed. Most patients (95.2%) received platinum-based chemotherapy. A total of 12 patients (3.4%) suffered an ATE within a median time of 3.6 months from the start of chemotherapy. The most frequent ATE was ischemic stroke (n = 7). Two ATEs were fatal. The 6-month and 24-month incidence were 2.1% (95% confidence interval [CI]: 0.9–4.1) and 3.6% (95% CI: 1.9–6.2), respectively. Perioperative chemotherapy increased the risk for ATE by 5.55-fold. Tumors other than UTC and pure non-transitional cell carcinoma histology were also independent risk factors. No association with the type of chemotherapy was found. Overall, ATEs occur in 4.6% of aUTC patients treated with chemotherapy and represent a clinically relevant manifestation. Perioperative chemotherapy significantly increases the risk for ATE. The role of prophylaxis in high-risk groups should be prospectively studied.

Published
2022
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48. Predictors of Response to Vedolizumab in Patients with Ulcerative Colitis: Results from the Greek VEDO-IBD Cohort

Author

Bamias, Giorgos, Kokkotis, Georgios, Gizis, Michalis, Kapizioni, Christina, Karmiris, Konstantinos, Koureta, Evgenia, Kyriakos, Nikolaos, Leonidakis, Georgios, Makris, Konstantinos, Markopoulos, Panagiotis, Michalopoulos, Georgios, Michopoulos, Spyridon, Papaconstantinou, Ioannis, Polymeros, Dimitrios, Siakavellas, Spyros I., Triantafyllou, Konstantinos, Tsironi, Eftychia, Tsoukali, Emmanouela, Tzouvala, Maria, Viazis, Nikos, Xourafas, Vassileios, Zacharopoulou, Eirini, Zampeli, Evanthia, Zografos, Konstantinos, Papatheodoridis, George, and Mantzaris, Gerasimos

Published
2022
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49. Predictive biomarkers for survival benefit with ramucirumab in urothelial cancer in the RANGE trial

Author

Michiel S. van der Heijden, Thomas Powles, Daniel Petrylak, Ronald de Wit, Andrea Necchi, Cora N. Sternberg, Nobuaki Matsubara, Hiroyuki Nishiyama, Daniel Castellano, Syed A. Hussain, Aristotelis Bamias, Georgios Gakis, Jae-Lyun Lee, Scott T. Tagawa, Ulka Vaishampayan, Jeanny B. Aragon-Ching, Bernie J. Eigl, Rebecca R. Hozak, Erik R. Rasmussen, Meng Summer Xia, Ryan Rhodes, Sameera Wijayawardana, Katherine M. Bell-McGuinn, Amit Aggarwal, and Alexandra Drakaki

Subjects
Science
Abstract

Identification of biomarkers to stratify patients who might benefit from treatment is needed to optimize targeted therapies. Here, based on an analysis of the RANGE trial (NCT02426125), the authors report potentially predictive biomarkers for survival benefit in patients with platinum-refractory advanced urothelial carcinoma treated with the anti-VEGFR2 monoclonal antibody ramucirumab.

Published
2022
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