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4. Inherited Germline Cancer Susceptibility Gene Variants in Individuals with Non-Muscle-Invasive Bladder Cancer

Author

Pietzak, Eugene J, Whiting, Karissa, Srinivasan, Preethi, Bandlamudi, Chaitanya, Khurram, Aliya, Joseph, Vijai, Walasek, Aleksandra, Bochner, Emily, Clinton, Timothy, Almassi, Nima, Truong, Hong, de Jesus Escano, Manuel R, Wiseman, Michal, Mandelker, Diana, Kemel, Yelena, Zhang, Liying, Walsh, Michael F, Cadoo, Karen A, Coleman, Jonathan A, Al-Ahmadie, Hikmat, Rosenberg, Jonathan E, Iyer, Gopakumar V, Solit, David B, Ostrovnaya, Irina, Offit, Kenneth, Robson, Mark E, Stadler, Zsofia K, Berger, Michael F, Bajorin, Dean F, Carlo, Maria, and Bochner, Bernard H

Subjects
Prevention, Cancer, Clinical Trials and Supportive Activities, Urologic Diseases, Clinical Research, Genetics, Aetiology, 2.1 Biological and endogenous factors, Good Health and Well Being, Adjuvants, Immunologic, BCG Vaccine, Carcinoma, Transitional Cell, Germ Cells, Humans, Neoplasm Invasiveness, Urinary Bladder Neoplasms, Xeroderma Pigmentosum Group D Protein, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeIdentification of inherited germline variants can guide personalized cancer screening, prevention, and treatment. Pathogenic and likely pathogenic (P/LP) germline variants in cancer predisposition genes are frequent among patients with locally advanced or metastatic urothelial carcinoma, but their prevalence and significance in patients with non-muscle-invasive bladder cancer (NMIBC), the most common form of urothelial carcinoma, is understudied.Experimental designGermline analysis was conducted on paired tumor/normal sequencing results from two distinct cohorts of patients initially diagnosed with NMIBC. Associations between clinicopathologic features and clinical outcomes with the presence of P/LP germline variants in ≥76 hereditary cancer predisposition genes were analyzed.ResultsA similar frequency of P/LP germline variants were seen in our two NMIBC cohorts [12% (12/99) vs. 8.7% (10/115), P = 0.4]. In the combined analysis, P/LP germline variants were found only in patients with high-grade NMIBC (22/163), but none of the 46 patients with low-grade NMIBC (13.5% vs. 0%, P = 0.005). Fifteen (9.2%) patients with high-grade NMIBC had P/LP variants in DNA damage response genes, most within the nucleotide excision repair (ERCC2/3) and homologous recombination repair (BRCA1, NBN, RAD50) pathways. Contrary to prior reports in patients with NMIBC not receiving Bacillus Calmette-Guerin (BCG), P/LP germline variants were not associated with worse recurrence-free or progression-free survival in patients treated with BCG or with risk of developing upper tract urothelial carcinoma.ConclusionsOur results support offering germline counseling and testing for all patients with high-grade bladder cancer, regardless of initial tumor stage. Therapeutic strategies that target impaired DNA repair may benefit patients with high-grade NMIBC.

Published
2022

5. Differential NEUROD1, ASCL1, and POU2F3 Expression Defines Molecular Subsets of Bladder Small Cell/Neuroendocrine Carcinoma With Prognostic Implications

Author

Akbulut, Dilara, Whiting, Karissa, Teo, Min-Yuen, Tallman, Jacob E., Ozcan, Gamze Gokturk, Basar, Merve, Jia, Liwei, Rammal, Rayan, Chen, Jie-Fu, Sarungbam, Judy, Chen, Ying-Bei, Gopalan, Anuradha, Fine, Samson W., Tickoo, Satish K., Mehra, Rohit, Baine, Marina, Bochner, Bernard H., Pietzak, Eugene J., Bajorin, Dean F., Rosenberg, Jonathan E., Iyer, Gopa, Solit, David B., Reuter, Victor E., Rekhtman, Natasha, Ostrovnaya, Irina, and Al-Ahmadie, Hikmat

Published
2024
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6. Neoplasia risk in patients with Lynch syndrome treated with immune checkpoint blockade

Author

Harrold, Emily C., Foote, Michael B., Rousseau, Benoit, Walch, Henry, Kemel, Yelena, Richards, Allison L., Keane, Fergus, Cercek, Andrea, Yaeger, Rona, Rathkopf, Dana, Segal, Neil H., Patel, Zalak, Maio, Anna, Borio, Matilde, O’Reilly, Eileen M., Reidy, Diane, Desai, Avni, Janjigian, Yelena Y., Murciano-Goroff, Yonina R., Carlo, Maria I., Latham, Alicia, Liu, Ying L., Walsh, Michael F., Ilson, David, Rosenberg, Jonathan E., Markowitz, Arnold J., Weiser, Martin R., Rossi, Anthony M., Vanderbilt, Chad, Mandelker, Diana, Bandlamudi, Chaitanya, Offit, Kenneth, Berger, Michael F., Solit, David B., Saltz, Leonard, Shia, Jinru, Diaz, Jr., Luis A., and Stadler, Zsofia K.

Published
2023
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7. Health-related Quality of Life in Patients with Previously Treated Advanced Urothelial Carcinoma from EV-301: A Phase 3 Trial of Enfortumab Vedotin Versus Chemotherapy

Author

Rosenberg, Jonathan E., Mamtani, Ronac, Sonpavde, Guru P., Loriot, Yohann, Duran, Ignacio, Lee, Jae-Lyun, Matsubara, Nobuaki, Vulsteke, Christof, Castellano, Daniel, Sridhar, Srikala S., Pappot, Helle, Gurney, Howard, Bedke, Jens, van der Heijden, Michiel S., Galli, Luca, Keam, Bhumsuk, Masumori, Naoya, Meran, Johannes, O'Donnell, Peter H., Park, Se Hoon, Grande, Enrique, Sengeløv, Lisa, Uemura, Hiroji, Skaltsa, Konstantina, Campbell, Mary, Matsangou, Maria, Wu, Chunzhang, Hepp, Zsolt, McKay, Caroline, Powles, Thomas, and Petrylak, Daniel P.

Published
2024
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8. Natural History and Genomic Landscape of Chemotherapy-Resistant Muscle-Invasive Bladder Cancer

Author

Lenis, Andrew T., Whiting, Karissa, Ravichandran, Vignesh, Tallman, Jacob E., Alam, Syed M., Chu, Carissa E., Jesus Escano, Manual De, Bochner, Emily, Katims, Andrew, Reisz, Peter A., Truong, Hong, Clinton, Timothy N., Telis, Leon, Dason, Shawn, McPherson, Victor, Teo, Min Yuen, Funt, Samuel, Aggen, David, Goh, Alvin C., Donahue, Timothy F., Cha, Eugene K., Donat, S. Machele, Herr, Harry W., Dalbagni, Guido, Schultz, Nikolaus, Berger, Michael F., Bajorin, Dean F., Rosenberg, Jonathan E., Bochner, Bernard H., Ostrovnaya, Irina, Al-Ahmadie, Hikmat, Solit, David B., Iyer, Gopa, and Pietzak, Eugene J.

Published
2024
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9. Molecular Heterogeneity and Immune Infiltration Drive Clinical Outcomes in Upper Tract Urothelial Carcinoma

Author

Kim, Kwanghee, Alam, Syed M., Kuo, Fengshen, Chen, Ziyu, Yip, Wesley, Katims, Andrew B., Chu, Carissa, Lenis, Andrew T., Hu, Wenhuo, Gokturk Ozcan, Gamze, Chen, Jie-Fu, Firouzi, Sanaz, Elhanati, Yuval, Clinton, Timothy N., Aulitzky, Andreas, Almassi, Nima, Fujii, Yoich, Tracey, Andrew T., Reisz, Peter A., Budhu, Sadna, Vuong, Lynda, Eichholz, Jordan, Woo, Hyung Jun, Nogueira, Lucas, Gao, Sizhi P., Scherz, Avigdor, Aggen, David H., Rosenberg, Jonathan E., Pietzak, Eugene J., Seshan, Venkatraman, Greenbaum, Benjamin, Becker, Anton, Akin, Oguz, Iyer, Gopa, Al-Ahmadie, Hikmat, Hakimi, A. Ari, Merghoub, Taha, Solit, David B., and Coleman, Jonathan A.

Published
2024
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11. Genomic heterogeneity as a barrier to precision oncology in urothelial cancer

Author

Clinton, Timothy N., Chen, Ziyu, Wise, Hannah, Lenis, Andrew T., Chavan, Shweta, Donoghue, Mark T.A., Almassi, Nima, Chu, Carissa E., Dason, Shawn, Rao, Pavitra, Rodrigues, James A., Vasani, Naresh B., Ridouani, Fourat, Rosenberg, Jonathan E., Bajorin, Dean F., Teo, Min Yuen, Bochner, Bernard H., Berger, Michael F., Ostrovnaya, Irina, Pietzak, Eugene J., Iyer, Gopa, Gao, Sizhi Paul, Hu, Wenhuo, Al-Ahmadie, Hikmat A., and Solit, David B.

Published
2022
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12. Long-term Outcomes of Local and Metastatic Small Cell Carcinoma of the Urinary Bladder and Genomic Analysis of Patients Treated With Neoadjuvant Chemotherapy

Author

Teo, Min Yuen, Guercio, Brendan J., Arora, Arshi, Hao, Xueli, Regazzi, Ashley M., Donahue, Timothy, Herr, Harry W., Goh, Alvin C., Cha, Eugene K., Pietzak, Eugene, Donat, Sherri M., Dalbagni, Guido, Bochner, Bernard H., Olgac, Semra, Sarungbam, Judy, Sirintrapun, S. Joseph, Chen, Ying-Bei, Gopalan, Anuradha, Fine, Samson W., Tickoo, Satish K., Reuter, Victor E., Weigelt, Britta, Schultheis, Anne M., Funt, Samuel A., Bajorin, Dean F., Solit, David B., Iyer, Gopa, Ostrovnaya, Irina, Rosenberg, Jonathan E., and Al-Ahmadie, Hikmat

Published
2022
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13. Fundamental immune–oncogenicity trade-offs define driver mutation fitness

Author

Hoyos, David, Zappasodi, Roberta, Schulze, Isabell, Sethna, Zachary, de Andrade, Kelvin César, Bajorin, Dean F., Bandlamudi, Chaitanya, Callahan, Margaret K., Funt, Samuel A., Hadrup, Sine R., Holm, Jeppe S., Rosenberg, Jonathan E., Shah, Sohrab P., Vázquez-García, Ignacio, Weigelt, Britta, Wu, Michelle, Zamarin, Dmitriy, Campitelli, Laura F., Osborne, Edward J., Klinger, Mark, Robins, Harlan S., Khincha, Payal P., Savage, Sharon A., Balachandran, Vinod P., Wolchok, Jedd D., Hellmann, Matthew D., Merghoub, Taha, Levine, Arnold J., Łuksza, Marta, and Greenbaum, Benjamin D.

Published
2022
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16. Genomic characterization of metastatic patterns from prospective clinical sequencing of 25,000 patients

Author

Nguyen, Bastien, Fong, Christopher, Luthra, Anisha, Smith, Shaleigh A., DiNatale, Renzo G., Nandakumar, Subhiksha, Walch, Henry, Chatila, Walid K., Madupuri, Ramyasree, Kundra, Ritika, Bielski, Craig M., Mastrogiacomo, Brooke, Donoghue, Mark T.A., Boire, Adrienne, Chandarlapaty, Sarat, Ganesh, Karuna, Harding, James J., Iacobuzio-Donahue, Christine A., Razavi, Pedram, Reznik, Ed, Rudin, Charles M., Zamarin, Dmitriy, Abida, Wassim, Abou-Alfa, Ghassan K., Aghajanian, Carol, Cercek, Andrea, Chi, Ping, Feldman, Darren, Ho, Alan L., Iyer, Gopakumar, Janjigian, Yelena Y., Morris, Michael, Motzer, Robert J., O’Reilly, Eileen M., Postow, Michael A., Raj, Nitya P., Riely, Gregory J., Robson, Mark E., Rosenberg, Jonathan E., Safonov, Anton, Shoushtari, Alexander N., Tap, William, Teo, Min Yuen, Varghese, Anna M., Voss, Martin, Yaeger, Rona, Zauderer, Marjorie G., Abu-Rustum, Nadeem, Garcia-Aguilar, Julio, Bochner, Bernard, Hakimi, Abraham, Jarnagin, William R., Jones, David R., Molena, Daniela, Morris, Luc, Rios-Doria, Eric, Russo, Paul, Singer, Samuel, Strong, Vivian E., Chakravarty, Debyani, Ellenson, Lora H., Gopalan, Anuradha, Reis-Filho, Jorge S., Weigelt, Britta, Ladanyi, Marc, Gonen, Mithat, Shah, Sohrab P., Massague, Joan, Gao, Jianjiong, Zehir, Ahmet, Berger, Michael F., Solit, David B., Bakhoum, Samuel F., Sanchez-Vega, Francisco, and Schultz, Nikolaus

Published
2022
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18. TGFβ attenuates tumour response to PD-L1 blockade by contributing to exclusion of T cells.

Author

Mariathasan, Sanjeev, Turley, Shannon J, Nickles, Dorothee, Castiglioni, Alessandra, Yuen, Kobe, Wang, Yulei, Kadel, Edward E, Koeppen, Hartmut, Astarita, Jillian L, Cubas, Rafael, Jhunjhunwala, Suchit, Banchereau, Romain, Yang, Yagai, Guan, Yinghui, Chalouni, Cecile, Ziai, James, Şenbabaoğlu, Yasin, Santoro, Stephen, Sheinson, Daniel, Hung, Jeffrey, Giltnane, Jennifer M, Pierce, Andrew A, Mesh, Kathryn, Lianoglou, Steve, Riegler, Johannes, Carano, Richard AD, Eriksson, Pontus, Höglund, Mattias, Somarriba, Loan, Halligan, Daniel L, van der Heijden, Michiel S, Loriot, Yohann, Rosenberg, Jonathan E, Fong, Lawrence, Mellman, Ira, Chen, Daniel S, Green, Marjorie, Derleth, Christina, Fine, Gregg D, Hegde, Priti S, Bourgon, Richard, and Powles, Thomas

Subjects
Urothelium, CD8-Positive T-Lymphocytes, Fibroblasts, Animals, Humans, Mice, Urologic Neoplasms, Neoplasm Metastasis, Disease Models, Animal, Collagen, Transforming Growth Factor beta, Antibodies, Antibodies, Monoclonal, Antigens, Neoplasm, Treatment Outcome, Immunotherapy, Cohort Studies, Signal Transduction, Drug Resistance, Neoplasm, Phenotype, Mutation, Tumor Microenvironment, Antibodies, Monoclonal, Humanized, Cell Cycle Checkpoints, B7-H1 Antigen, Monoclonal, Humanized, Antigens, Neoplasm, Disease Models, Animal, Drug Resistance, General Science & Technology
Abstract

Therapeutic antibodies that block the programmed death-1 (PD-1)-programmed death-ligand 1 (PD-L1) pathway can induce robust and durable responses in patients with various cancers, including metastatic urothelial cancer. However, these responses only occur in a subset of patients. Elucidating the determinants of response and resistance is key to improving outcomes and developing new treatment strategies. Here we examined tumours from a large cohort of patients with metastatic urothelial cancer who were treated with an anti-PD-L1 agent (atezolizumab) and identified major determinants of clinical outcome. Response to treatment was associated with CD8+ T-effector cell phenotype and, to an even greater extent, high neoantigen or tumour mutation burden. Lack of response was associated with a signature of transforming growth factor β (TGFβ) signalling in fibroblasts. This occurred particularly in patients with tumours, which showed exclusion of CD8+ T cells from the tumour parenchyma that were instead found in the fibroblast- and collagen-rich peritumoural stroma; a common phenotype among patients with metastatic urothelial cancer. Using a mouse model that recapitulates this immune-excluded phenotype, we found that therapeutic co-administration of TGFβ-blocking and anti-PD-L1 antibodies reduced TGFβ signalling in stromal cells, facilitated T-cell penetration into the centre of tumours, and provoked vigorous anti-tumour immunity and tumour regression. Integration of these three independent biological features provides the best basis for understanding patient outcome in this setting and suggests that TGFβ shapes the tumour microenvironment to restrain anti-tumour immunity by restricting T-cell infiltration.

Published
2018

19. A multifactorial model of T cell expansion and durable clinical benefit in response to a PD-L1 inhibitor.

Author

Leiserson, Mark DM, Syrgkanis, Vasilis, Gilson, Amy, Dudik, Miroslav, Gillett, Sharon, Chayes, Jennifer, Borgs, Christian, Bajorin, Dean F, Rosenberg, Jonathan E, Funt, Samuel, Snyder, Alexandra, and Mackey, Lester

Subjects
T-Lymphocytes, Lymphocytes, Tumor-Infiltrating, Humans, Carcinoma, Transitional Cell, Antibodies, Monoclonal, Protein Kinase Inhibitors, Treatment Outcome, Immunotherapy, Models, Statistical, Risk Assessment, Cell Proliferation, Mutation, Adult, Female, Male, Urinary Bladder Neoplasms, Biomarkers, Pharmacological, Antibodies, Monoclonal, Humanized, Clonal Evolution, Biomarkers, Tumor, B7-H1 Antigen, Antibodies, Monoclonal, Humanized, Biomarkers, Pharmacological, Tumor, Carcinoma, Transitional Cell, Lymphocytes, Tumor-Infiltrating, Models, Statistical, General Science & Technology
Abstract

Checkpoint inhibitor immunotherapies have had major success in treating patients with late-stage cancers, yet the minority of patients benefit. Mutation load and PD-L1 staining are leading biomarkers associated with response, but each is an imperfect predictor. A key challenge to predicting response is modeling the interaction between the tumor and immune system. We begin to address this challenge with a multifactorial model for response to anti-PD-L1 therapy. We train a model to predict immune response in patients after treatment based on 36 clinical, tumor, and circulating features collected prior to treatment. We analyze data from 21 bladder cancer patients using the elastic net high-dimensional regression procedure and, as training set error is a biased and overly optimistic measure of prediction error, we use leave-one-out cross-validation to obtain unbiased estimates of accuracy on held-out patients. In held-out patients, the model explains 79% of the variance in T cell clonal expansion. This predicted immune response is multifactorial, as the variance explained is at most 23% if clinical, tumor, or circulating features are excluded. Moreover, if patients are triaged according to predicted expansion, only 38% of non-durable clinical benefit (DCB) patients need be treated to ensure that 100% of DCB patients are treated. In contrast, using mutation load or PD-L1 staining alone, one must treat at least 77% of non-DCB patients to ensure that all DCB patients receive treatment. Thus, integrative models of immune response may improve our ability to anticipate clinical benefit of immunotherapy.

Published
2018

20. Neoantigen-specific CD8 T cell responses in the peripheral blood following PD-L1 blockade might predict therapy outcome in metastatic urothelial carcinoma

Author

Holm, Jeppe Sejerø, Funt, Samuel A., Borch, Annie, Munk, Kamilla Kjærgaard, Bjerregaard, Anne-Mette, Reading, James L., Maher, Colleen, Regazzi, Ashley, Wong, Phillip, Al-Ahmadie, Hikmat, Iyer, Gopa, Tamhane, Tripti, Bentzen, Amalie Kai, Herschend, Nana Overgaard, De Wolf, Susan, Snyder, Alexandra, Merghoub, Taha, Wolchok, Jedd D., Nielsen, Morten, Rosenberg, Jonathan E., Bajorin, Dean F., and Hadrup, Sine Reker

Published
2022
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21. Author Correction: FOXA1 repression drives lineage plasticity and immune heterogeneity in bladder cancers with squamous differentiation

Author

Warrick, Joshua I., Hu, Wenhuo, Yamashita, Hironobu, Walter, Vonn, Shuman, Lauren, Craig, Jenna M., Gellert, Lan L., Castro, Mauro A. A., Robertson, A. Gordon, Kuo, Fengshen, Ostrovnaya, Irina, Sarungbam, Judy, Chen, Ying-bei, Gopalan, Anuradha, Sirintrapun, Sahussapont J., Fine, Samson W., Tickoo, Satish K., Kim, Kwanghee, Thomas, Jasmine, Karan, Nagar, Gao, Sizhi Paul, Clinton, Timothy N., Lenis, Andrew T., Chan, Timothy A., Chen, Ziyu, Rao, Manisha, Hollman, Travis J., Li, Yanyun, Socci, Nicholas D., Chavan, Shweta, Viale, Agnes, Mohibullah, Neeman, Bochner, Bernard H., Pietzak, Eugene J., Teo, Min Yuen, Iyer, Gopa, Rosenberg, Jonathan E., Bajorin, Dean F., Kaag, Matthew, Merrill, Suzanne B., Joshi, Monika, Adam, Rosalyn, Taylor, III, John A., Clark, Peter E., Raman, Jay D., Reuter, Victor E., Chen, Yu, Funt, Samuel A., Solit, David B., DeGraff, David J., and Al-Ahmadie, Hikmat A.

Published
2022
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22. FOXA1 repression drives lineage plasticity and immune heterogeneity in bladder cancers with squamous differentiation

Author

Warrick, Joshua I., Hu, Wenhuo, Yamashita, Hironobu, Walter, Vonn, Shuman, Lauren, Craig, Jenna M., Gellert, Lan L., Castro, Mauro A. A., Robertson, A. Gordon, Kuo, Fengshen, Ostrovnaya, Irina, Sarungbam, Judy, Chen, Ying-bei, Gopalan, Anuradha, Sirintrapun, Sahussapont J., Fine, Samson W., Tickoo, Satish K., Kim, Kwanghee, Thomas, Jasmine, Karan, Nagar, Gao, Sizhi Paul, Clinton, Timothy N., Lenis, Andrew T., Chan, Timothy A., Chen, Ziyu, Rao, Manisha, Hollman, Travis J., Li, Yanyun, Socci, Nicholas D., Chavan, Shweta, Viale, Agnes, Mohibullah, Neeman, Bochner, Bernard H., Pietzak, Eugene J., Teo, Min Yuen, Iyer, Gopa, Rosenberg, Jonathan E., Bajorin, Dean F., Kaag, Matthew, Merrill, Suzanne B., Joshi, Monika, Adam, Rosalyn, Taylor, III, John A., Clark, Peter E., Raman, Jay D., Reuter, Victor E., Chen, Yu, Funt, Samuel A., Solit, David B., DeGraff, David J., and Al-Ahmadie, Hikmat A.

Published
2022
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23. Impact of exposure on outcomes with enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer.

Author

Petrylak, Daniel P., primary, Chia, Yen Lin, additional, Yu, Evan Y., additional, Powles, Thomas, additional, Flaig, Thomas W., additional, Loriot, Yohann, additional, O'Donnell, Peter H., additional, Heath, Elisabeth I., additional, Kojima, Takahiro, additional, Park, Se Hoon, additional, Sonpavde, Guru P., additional, Picus, Joel, additional, Matsubara, Nobuaki, additional, Obara, Wataru, additional, Chudasama, Vaishali, additional, Poondru, Srinivasu, additional, Harrison, Michael, additional, Kim, Eric, additional, Brancato, Sam Joseph, additional, and Rosenberg, Jonathan E., additional

Published
2024
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24. A phase 2 trial of ADT interruption in patients responding exceptionally to AR-pathway inhibitor in metastatic hormone-sensitive prostate cancer (A-DREAM/Alliance A032101).

Author

Choudhury, Atish Dipankar, primary, Heller, Glenn, additional, Reimers, Melissa Andrea, additional, Laccetti, Andrew Leonard, additional, Smieliauskas, Fabrice, additional, Ravi, Praful, additional, Dooley, Katharine, additional, Mazza, Gina L., additional, Gartrell, Benjamin Adam, additional, Steen, Preston D., additional, Kroll, Kayla, additional, Baghaie, Shiva, additional, Ajmera, Archana, additional, Smith, Thomas J., additional, Beltran, Himisha, additional, Chen, Ronald C., additional, McKay, Rana R., additional, Galsky, Matt D., additional, Rosenberg, Jonathan E., additional, and Morris, Michael J., additional

Published
2024
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26. MP16-17 PHASE I STUDY OF INTRAVESICAL FC-OPTIMIZED ANTI-CD40 AGONIST ANTIBODY 2141-V11 FOR NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC) UNRESPONSIVE TO BACILLUS CALMETTE-GUERIN (BCG)

Author

Bochner, Bernard H., primary, Alam, Muneeb, additional, Osorio, Juan C., additional, Wong, Jeffrey L., additional, Knorr, David, additional, Blanchard, Lucas, additional, Angulo-Lozano, Juan, additional, Whiting, Karissa, additional, Seshan, Venkatraman E., additional, Donahue, Timothy, additional, Cha, Eugene, additional, Goh, Alvin, additional, Smith, Robert, additional, Dalbagni, Guido, additional, Hernandez, Christian, additional, McCarter, Melissa, additional, Pietzak, Eugene J., additional, Rosenberg, Jonathan E., additional, and Ravetch, Jeffrey V., additional

Published
2024
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27. Mismatch repair deficiency and microsatellite instability in urothelial carcinoma: a systematic review and meta-analysis

Author

Chandran, Elias B A, primary, Iannantuono, Giovanni Maria, additional, Atiq, Saad O, additional, Akbulut, Dilara, additional, Sinaii, Ninet, additional, Simon, Nicholas I, additional, Banday, Abdul Rouf, additional, Boudjadi, Salah, additional, Gurram, Sandeep, additional, Nassar, Amin H, additional, Rosenberg, Jonathan E, additional, Butera, Gisela, additional, Teo, Min Yuen, additional, Sonpavde, Guru, additional, Coleman, Jonathan A, additional, and Apolo, Andrea B, additional

Published
2024
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29. Partial Response and Stable Disease Correlate with Positive Outcomes in Atezolizumab-treated Patients with Advanced Urinary Tract Carcinoma

Author

Bedke, Jens, Merseburger, Axel S., Loriot, Yohann, Castellano, Daniel, Choy, Ernest, Duran, Ignacio, Rosenberg, Jonathan E., Petrylak, Daniel P., Dreicer, Robert, Perez-Gracia, Jose L., Hoffman-Censits, Jean H., Van Der Heijden, Michiel S., Pavlova, Julie, Thiebach, Lars, de Ducla, Sabine, Fear, Simon, Powles, Thomas, and Sternberg, Cora N.

Published
2021
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31. Enfortumab vedotin after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients with advanced urothelial carcinoma (EV‑201): a multicentre, single-arm, phase 2 trial

Author

Yu, Evan Y, Petrylak, Daniel P, O'Donnell, Peter H, Lee, Jae-Lyun, van der Heijden, Michiel S, Loriot, Yohann, Stein, Mark N, Necchi, Andrea, Kojima, Takahiro, Harrison, Michael R, Hoon Park, Se, Quinn, David I, Heath, Elisabeth I, Rosenberg, Jonathan E, Steinberg, Joyce, Liang, Shang-Ying, Trowbridge, Janet, Campbell, Mary, McGregor, Bradley, and Balar, Arjun V

Published
2021
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33. Adjuvant atezolizumab versus observation in muscle-invasive urothelial carcinoma (IMvigor010): a multicentre, open-label, randomised, phase 3 trial

Author

Bellmunt, Joaquim, Hussain, Maha, Gschwend, Jürgen E, Albers, Peter, Oudard, Stephane, Castellano, Daniel, Daneshmand, Siamak, Nishiyama, Hiroyuki, Majchrowicz, Martin, Degaonkar, Viraj, Shi, Yi, Mariathasan, Sanjeev, Grivas, Petros, Drakaki, Alexandra, O'Donnell, Peter H, Rosenberg, Jonathan E, Geynisman, Daniel M, Petrylak, Daniel P, Hoffman-Censits, Jean, Bedke, Jens, Kalebasty, Arash Rezazadeh, Zakharia, Yousef, van der Heijden, Michiel S, Sternberg, Cora N, Davarpanah, Nicole N, and Powles, Thomas

Published
2021
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34. Hyperphosphatemia Secondary to the Selective Fibroblast Growth Factor Receptor 1–3 Inhibitor Infigratinib (BGJ398) Is Associated with Antitumor Efficacy in Fibroblast Growth Factor Receptor 3–altered Advanced/Metastatic Urothelial Carcinoma

Author

Lyou, Yung, Grivas, Petros, Rosenberg, Jonathan E., Hoffman-Censits, Jean, Quinn, David I., P. Petrylak, Daniel, Galsky, Matthew, Vaishampayan, Ulka, De Giorgi, Ugo, Gupta, Sumati, Burris, Howard, Rearden, Jessica, Li, Ai, Wang, Hao, Reyes, Maribel, Moran, Susan, Daneshmand, Siamak, Bajorin, Dean, and Pal, Sumanta K.

Published
2020
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35. Fibroblast Growth Factor Receptor 3 Alteration Status is Associated with Differential Sensitivity to Platinum-based Chemotherapy in Locally Advanced and Metastatic Urothelial Carcinoma

Author

Teo, Min Yuen, Mota, Jose Mauricio, Whiting, Karissa A., Li, Han A., Funt, Samuel A., Lee, Chung-Han, Solit, David B., Al-Ahmadie, Hikmat, Milowsky, Matthew I., Balar, Arjun V., Pietzak, Eugene, Dalbagni, Guido, Bochner, Bernard H., Ostrovnaya, Irina, Bajorin, Dean F., Rosenberg, Jonathan E., and Iyer, Gopa

Published
2020
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37. Unfavorable Cancer-specific Survival After Neoadjuvant Chemotherapy and Radical Cystectomy in Patients With Bladder Cancer and Squamous Cell Variant: A Multi-institutional Study

Author

Bandini, Marco, Pederzoli, Filippo, Madison, Russell, Briganti, Alberto, Ross, Jeffrey S., Niegisch, Günter, Yu, Evan Y., Bamias, Aristotelis, Agarwal, Neeraj, Sridhar, Srikala S., Rosenberg, Jonathan E., Bellmunt, Joaquim, Pal, Sumanta Kumar, Galsky, Matthew D., Lucianò, Roberta, Gallina, Andrea, Salonia, Andrea, Montorsi, Francesco, Ali, Siraj M., Chung, Jon H., and Necchi, Andrea

Published
2020
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38. Efficacy of Surgery in the Primary Tumor Site for Metastatic Urothelial Cancer: Analysis of an International, Multicenter, Multidisciplinary Database

Author

Moschini, Marco, Xylinas, Evanguelos, Zamboni, Stefania, Mattei, Agostino, Niegisch, Günter, Yu, Evan Y., Bamias, Aristotelis, Agarwal, Neeraj, Sridhar, Srikala S., Sternberg, Cora N., Vaishampayan, Ulka N., Rosenberg, Jonathan E., Bellmunt, Joaquim, Galsky, Matthew D., Montorsi, Francesco, and Necchi, Andrea

Published
2020
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39. EAU-ESMO Consensus Statements on the Management of Advanced and Variant Bladder Cancer—An International Collaborative Multistakeholder Effort†: Under the Auspices of the EAU-ESMO Guidelines Committees

Author

Witjes, J. Alfred, Babjuk, Marek, Bellmunt, Joaquim, Bruins, H. Maxim, De Reijke, Theo M., De Santis, Maria, Gillessen, Silke, James, Nicholas, Maclennan, Steven, Palou, Juan, Powles, Tom, Ribal, Maria J., Shariat, Shahrokh F., Der Kwast, Theo Van, Xylinas, Evanguelos, Agarwal, Neeraj, Arends, Tom, Bamias, Aristotle, Birtle, Alison, Black, Peter C., Bochner, Bernard H., Bolla, Michel, Boormans, Joost L., Bossi, Alberto, Briganti, Alberto, Brummelhuis, Iris, Burger, Max, Castellano, Daniel, Cathomas, Richard, Chiti, Arturo, Choudhury, Ananya, Compérat, Eva, Crabb, Simon, Culine, Stephane, De Bari, Berardino, De Blok, Willem, J.L. De Visschere, Pieter, Decaestecker, Karel, Dimitropoulos, Konstantinos, Dominguez-Escrig, Jose L., Fanti, Stefano, Fonteyne, Valerie, Frydenberg, Mark, Futterer, Jurgen J., Gakis, Georgios, Geavlete, Bogdan, Gontero, Paolo, Grubmüller, Bernhard, Hafeez, Shaista, Hansel, Donna E., Hartmann, Arndt, Hayne, Dickon, Henry, Ann M., Hernandez, Virginia, Herr, Harry, Herrmann, Ken, Hoskin, Peter, Huguet, Jorge, Jereczek-Fossa, Barbara A., Jones, Rob, Kamat, Ashish M., Khoo, Vincent, Kiltie, Anne E., Krege, Susanne, Ladoire, Sylvain, Lara, Pedro C., Leliveld, Annemarie, Linares-Espinós, Estefania, Løgager, Vibeke, Lorch, Anja, Loriot, Yohann, Meijer, Richard, Mir, M. Carmen, Moschini, Marco, Mostafid, Hugh, Müller, Arndt-Christian, Müller, Christoph R., N'Dow, James, Necchi, Andrea, Neuzillet, Yann, Oddens, Jorg R., Oldenburg, Jan, Osanto, Susanne, J.G. Oyen, Wim, Pacheco-Figueiredo, Luís, Pappot, Helle, Patel, Manish I., Pieters, Bradley R., Plass, Karin, Remzi, Mesut, Retz, Margitta, Richenberg, Jonathan, Rink, Michael, Roghmann, Florian, Rosenberg, Jonathan E., Rouprêt, Morgan, Rouvière, Olivier, Salembier, Carl, Salminen, Antti, Sargos, Paul, Sengupta, Shomik, Sherif, Amir, Smeenk, Robert J., Smits, Anita, Stenzl, Arnulf, Thalmann, George N., Tombal, Bertrand, Turkbey, Baris, Lauridsen, Susanne Vahr, Valdagni, Riccardo, Van Der Heijden, Antoine G., Van Poppel, Hein, Vartolomei, Mihai D., Veskimäe, Erik, Vilaseca, Antoni, Rivera, Franklin A. Vives, Wiegel, Thomas, Wiklund, Peter, Williams, Andrew, Zigeuner, Richard, and Horwich, Alan

Published
2020
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40. Natural history, response to systemic therapy, and genomic landscape of plasmacytoid urothelial carcinoma

Author

Teo, Min Yuen, Al-Ahmadie, Hikmat, Seier, Kenneth, Tully, Christopher, Regazzi, Ashley M., Pietzak, Eugene, Solit, David B., Tickoo, Satish, Reuter, Victor, Cha, Eugene K., Herr, Harry, Donahue, Timothy, Donat, Sherri M., Dalbagni, Guido, Bochner, Bernard H., Funt, Samuel, Iyer, Gopakumar V., Bajorin, Dean F., Ostrovnaya, Irina, and Rosenberg, Jonathan E.

Published
2021
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42. Clinical and Genomic Characterization of Bladder Carcinomas With Glandular Phenotype

Author

Almassi, Nima, Whiting, Karissa, Toubaji, Antoun, Lenis, Andrew T., Jordan, Emmet J., Won, Helen, Regazzi, Ashley M., Chen, Ying-Bei, Gopalan, Anuradha, Sirintrapun, Sahussapont J., Fine, Samson W., Tickoo, Satish K., Ostrovnaya, Irina, Pietzak, Eugene J., Cha, Eugene K., Goh, Alvin C., Donahue, Timothy F., Herr, Harry W., Donat, S. Machele, Dalbagni, Guido, Bochner, Bernard H., Teo, Min Yuen, Funt, Samuel A., Rosenberg, Jonathan E., Reuter, Victor E., Bajorin, Dean F., Solit, David B., Al-Ahmadie, Hikmat, and Iyer, Gopa

Published
2022
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43. High systemic and tumor-associated IL-8 correlates with reduced clinical benefit of PD-L1 blockade

Author

Yuen, Kobe C., Liu, Li-Fen, Gupta, Vinita, Madireddi, Shravan, Keerthivasan, Shilpa, Li, Congfen, Rishipathak, Deepali, Williams, Patrick, Kadel, Edward E., III, Koeppen, Harmut, Chen, Ying-Jiun, Modrusan, Zora, Grogan, Jane L., Banchereau, Romain, Leng, Ning, Thastrom, Ann Christine, Shen, Xiadong, Hashimoto, Kenji, Tayama, Darren, van der Heijden, Michiel S., Rosenberg, Jonathan E., McDermott, David F., Powles, Thomas, Hegde, Priti S., Huseni, Mahrukh A., and Mariathasan, Sanjeev

Subjects
Interleukin-8 -- Health aspects, Metastasis -- Drug therapy -- Patient outcomes, Bladder cancer -- Drug therapy -- Patient outcomes, Apoptotic proteins -- Health aspects, Carcinoma, Renal cell -- Drug therapy -- Patient outcomes, Monoclonal antibodies -- Patient outcomes -- Health aspects, Biological sciences, Health
Abstract

Although elevated plasma interleukin-8 (pIL-8) has been associated with poor outcome to immune checkpoint blockade.sup.1, this has not been comprehensively evaluated in large randomized studies. Here we analyzed circulating pIL-8 and IL8 gene expression in peripheral blood mononuclear cells and tumors of patients treated with atezolizumab (anti-PD-L1 monoclonal antibody) from multiple randomized trials representing 1,445 patients with metastatic urothelial carcinoma (mUC) and metastatic renal cell carcinoma. High levels of IL-8 in plasma, peripheral blood mononuclear cells and tumors were associated with decreased efficacy of atezolizumab in patients with mUC and metastatic renal cell carcinoma, even in tumors that were classically CD8.sup.+ T cell inflamed. Low baseline pIL-8 in patients with mUC was associated with increased response to atezolizumab and chemotherapy. Patients with mUC who experienced on-treatment decreases in pIL-8 exhibited improved overall survival when treated with atezolizumab but not with chemotherapy. Single-cell RNA sequencing of the immune compartment showed that IL8 is primarily expressed in circulating and intratumoral myeloid cells and that high IL8 expression is associated with downregulation of the antigen-presentation machinery. Therapies that can reverse the impacts of IL-8-mediated myeloid inflammation will be essential for improving outcomes of patients treated with immune checkpoint inhibitors. In a retrospective analysis of data from three clinical trials, increased baseline peripheral and tumor IL-8 levels were associated with worse clinical outcomes in patients with metastatic urothelial carcinoma and metastatic renal cell carcinoma treated with anti-PD-L1 therapy., Author(s): Kobe C. Yuen [sup.1] , Li-Fen Liu [sup.1] , Vinita Gupta [sup.1] , Shravan Madireddi [sup.1] , Shilpa Keerthivasan [sup.1] , Congfen Li [sup.1] , Deepali Rishipathak [sup.1] , [...]

Published
2020
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44. Modeling 1-year Relapse-free Survival After Neoadjuvant Chemotherapy and Radical Cystectomy in Patients with Clinical T2–4N0M0 Urothelial Bladder Carcinoma: Endpoints for Phase 2 Trials

Author

Bandini, Marco, Briganti, Alberto, Plimack, Elizabeth R., Niegisch, Günter, Yu, Evan Y., Bamias, Aristotelis, Agarwal, Neeraj, Sridhar, Srikala S., Sternberg, Cora N., Vaishampayan, Ulka, Théodore, Christine, Rosenberg, Jonathan E., Bellmunt, Joaquim, Galsky, Matthew D., Montorsi, Francesco, and Necchi, Andrea

Published
2019
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46. Development of a Prediction Tool for Exclusive Locoregional Recurrence After Radical Cystectomy in Patients With Muscle-Invasive Bladder Cancer

Author

Necchi, Andrea, Pond, Gregory R., Moschini, Marco, Plimack, Elizabeth R., Niegisch, Gunter, Yu, Evan Y., Bamias, Aristotelis, Agarwal, Neeraj, Vaishampayan, Ulka, Theodore, Christine, Sridhar, Srikala S., Rosenberg, Jonathan E., Bellmunt, Joaquim, Gallina, Andrea, Colombo, Renzo, Montorsi, Francesco, Briganti, Alberto, and Galsky, Matthew D.

Published
2019
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47. Genomic Differences Between “Primary” and “Secondary” Muscle-invasive Bladder Cancer as a Basis for Disparate Outcomes to Cisplatin-based Neoadjuvant Chemotherapy

Author

Pietzak, Eugene J., Zabor, Emily C., Bagrodia, Aditya, Armenia, Joshua, Hu, Wenhuo, Zehir, Ahmet, Funt, Samuel, Audenet, Francois, Barron, David, Maamouri, Noelia, Li, Qiang, Teo, Min Yuen, Arcila, Maria E., Berger, Michael F., Schultz, Nikolaus, Dalbagni, Guido, Herr, Harry W., Bajorin, Dean F., Rosenberg, Jonathan E., Al-Ahmadie, Hikmat, Bochner, Bernard H., Solit, David B., and Iyer, Gopa

Published
2019
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48. A phase II trial of AS1411 (a novel nucleolin-targeted DNA aptamer) in metastatic renal cell carcinoma

Author

Rosenberg, Jonathan E, Bambury, Richard M, Van Allen, Eliezer M, Drabkin, Harry A, Lara, Primo N, Harzstark, Andrea L, Wagle, Nikhil, Figlin, Robert A, Smith, Gregory W, Garraway, Levi A, Choueiri, Toni, Erlandsson, Fredrik, and Laber, Damian A

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Kidney Disease, Cancer, Clinical Trials and Supportive Activities, Rare Diseases, Clinical Research, Biotechnology, Genetics, Evaluation of treatments and therapeutic interventions, 4.2 Evaluation of markers and technologies, 6.1 Pharmaceuticals, Detection, screening and diagnosis, 6.2 Cellular and gene therapies, Adult, Aged, Aged, 80 and over, Aptamers, Nucleotide, Carcinoma, Renal Cell, Demography, Exome, Female, Humans, INDEL Mutation, Infusions, Intravenous, Kidney Neoplasms, Male, Middle Aged, Models, Molecular, Neoplasm Metastasis, Oligodeoxyribonucleotides, Phosphoproteins, RNA-Binding Proteins, Sequence Analysis, DNA, Treatment Outcome, AS1411, Nucleolin, Renal cell carcinoma, Aptamer, Pharmacology and Pharmaceutical Sciences, Oncology & Carcinogenesis, Oncology and carcinogenesis, Pharmacology and pharmaceutical sciences
Abstract

BackgroundDNA aptamers represent a novel strategy in anti-cancer medicine. AS1411, a DNA aptamer targeting nucleolin (a protein which is overexpressed in many tumor types), was evaluated in patients with metastatic, clear-cell, renal cell carcinoma (RCC) who had failed treatment with ≥1 prior tyrosine kinase inhibitor.MethodsIn this phase II, single-arm study, AS1411 was administered at 40 mg/kg/day by continuous intravenous infusion on days 1-4 of a 28-day cycle, for two cycles. Primary endpoint was overall response rate; progression-free survival (PFS) and safety were secondary endpoints.Results35 patients were enrolled and treated. One patient (2.9 %) had a response to treatment. The response was dramatic (84 % reduction in tumor burden by RECIST 1.0 criteria) and durable (patient remains free of progression 2 years after completing therapy). Whole exome sequencing of this patient's tumor revealed missense mutations in the mTOR and FGFR2 genes which is of interest because nucleolin is known to upregulate mTOR pathway activity by enhancing AKT1 mRNA translation. No other responses were seen. Thirty-four percent of patients had an AS1411-related adverse event, all of which were mild or moderate.ConclusionsAS1411 appears to have minimal activity in unselected patients with metastatic RCC. However, rare, dramatic and durable responses can be observed and toxicity is low. One patient in this study had an excellent response and was found to have FGFR2 and mTOR mutations which will be of interest in future efforts to discover and validate predictive biomarkers of response to nucleolin targeted compounds. DNA aptamers represent a novel way to target cancer cells at a molecular level and continue to be developed with a view to improving treatment and imaging in cancer medicine.

Published
2014

49. A plain language summary exploring a new treatment combination for untreated locally advanced or metastatic urothelial cancer: enfortumab vedotin plus pembrolizumab

Author

Hoimes, Christopher J, primary, Flaig, Thomas W, additional, Milowsky, Matthew I, additional, Friedlander, Terence W, additional, Bilen, Mehmet Asim, additional, Gupta, Shilpa, additional, Srinivas, Sandy, additional, Merchan, Jaime R, additional, McKay, Rana R, additional, Petrylak, Daniel P, additional, Sasse, Carolyn, additional, Moreno, Blanca Homet, additional, Yu, Yao, additional, Carret, Anne-Sophie, additional, and Rosenberg, Jonathan E, additional

Published
2023
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50. Supplemental Tables 1 from Clinical and Genomic Landscape of FGFR3-Altered Urothelial Carcinoma and Treatment Outcomes with Erdafitinib: A Real-World Experience

Author

Guercio, Brendan J., primary, Sarfaty, Michal, primary, Teo, Min Yuen, primary, Ratna, Neha, primary, Duzgol, Cihan, primary, Funt, Samuel A., primary, Lee, Chung-Han, primary, Aggen, David H., primary, Regazzi, Ashley M., primary, Chen, Ziyu, primary, Lattanzi, Michael, primary, Al-Ahmadie, Hikmat A., primary, Brannon, A. Rose, primary, Shah, Ronak, primary, Chu, Carissa, primary, Lenis, Andrew T., primary, Pietzak, Eugene, primary, Bochner, Bernard H., primary, Berger, Michael F., primary, Solit, David B., primary, Rosenberg, Jonathan E., primary, Bajorin, Dean F., primary, and Iyer, Gopa, primary

Published
2023
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