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51. A phase II trial of nivolumab followed by ipilimumab and nivolumab in advanced non‐clear‐cell renal cell carcinoma.

Author

Conduit, Ciara, Davis, Ian D., Goh, Jeffrey C., Kichenadasse, Ganessan, Gurney, Howard, Harris, Carole A., Pook, David, Krieger, Laurence, Parnis, Francis, Underhill, Craig, Adams, Diana, Roncolato, Felicia, Joshua, Anthony, Ferguson, Tom, Prithviraj, Prashanth, Morris, Michelle, Harrison, Michelle, Begbie, Stephen, Hovey, Elizabeth, and George, Mathew

Abstract

Objective: To evaluate the efficacy of sequential treatment with ipilimumab and nivolumab following progression on nivolumab monotherapy in individuals with advanced, non‐clear‐cell renal cell carcinoma (nccRCC). Materials and Methods: UNISoN (ANZUP1602; NCT03177239) was an open‐label, single‐arm, phase 2 clinical trial that recruited adults with immunotherapy‐naïve, advanced nccRCC. Participants received nivolumab 240 mg i.v. two‐weekly for up to 12 months (Part 1), followed by sequential addition of ipilimumab 1 mg/kg three‐weekly for four doses to nivolumab if disease progression occurred during treatment (Part 2). The primary endpoint was objective tumour response rate (OTRR) and secondary endpoints included duration of response (DOR), progression‐free (PFS) and overall survival (OS), and toxicity (treatment‐related adverse events). Results: A total of 83 participants were eligible for Part 1, including people with papillary (37/83, 45%), chromophobe (15/83, 18%) and other nccRCC subtypes (31/83, 37%); 41 participants enrolled in Part 2. The median (range) follow‐up was 22 (16–30) months. In Part 1, the OTRR was 16.9% (95% confidence interval [CI] 9.5–26.7), the median DOR was 20.7 months (95% CI 3.7‐not reached) and the median PFS was 4.0 months (95% CI 3.6–7.4). Treatment‐related adverse events were reported in 71% of participants; 19% were grade 3 or 4. For participants who enrolled in Part 2, the OTRR was 10%; the median DOR was 13.5 months (95% CI 4.8–19.7) and the median PFS 2.6 months (95% CI 2.2–3.8). Treatment‐related adverse events occurred in 80% of these participants; 49% had grade 3, 4 or 5. The median OS was 24 months (95% CI 16–28) from time of enrolment in Part 1. Conclusions: Nivolumab monotherapy had a modest effect overall, with a few participants experiencing a long DOR. Sequential combination immunotherapy by addition of ipilimumab in the context of disease progression to nivolumab in nccRCC is not supported by this study, with only a minority of participants benefiting from this strategy. [ABSTRACT FROM AUTHOR]

Published
2024
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53. Plain language summary of results from the JAVELIN Bladder 100 study: avelumab maintenance treatment for advanced urothelial cancer

Author

Powles Thomas, Park Se Hoon, Voog Eric, Caserta Claudia, Valderrama Begona P., Gurney Howard, Kalofonas Haralabos, Radulović Siniša, Demey Wim, Ullen Anders, Loriot Yohann, Sridhar Srikala S., Tsuchiya Norihiko, Kopyltsov Evgeny, Sternberg Cora N., Bellmunt Joaquim, Aragon-Ching, Jeanny B, Petrylak Daniel P, Laliberte Robert J., Huang Bo, Costa Nuno, Blake-Haskins John A., and Grivas Petros

Subjects
Carcinoma, Transitional Cell, Avelumab, Cancer Research, maintenance treatment, Drug-Related Side Effects and Adverse Reactions, treatment, Urinary Bladder, General Medicine, lay summary, Antibodies, Monoclonal, Humanized, JAVELIN bladder 100, Urinary Bladder Neoplasms, urothelial cancer, Oncology, JAVELIN Bladder 100, Quality of Life, Humans, bladder cancer, avelumab, immunotherapy, plain language summary, Language
Abstract

What is this summary about? This is a plain language summary of an article originally published in The New England Journal of Medicine. It is about initial results (collected in October 2019) from the JAVELIN Bladder 100 study (a clinical trial), which looked at avelumab maintenance treatment in people with advanced urothelial cancer. Urothelial cancer is the most common type of bladder cancer. People with advanced urothelial cancer often receive chemotherapy. If this is the first treatment people with advanced disease are given, it is called first-line treatment. If the cancer stops growing or shrinks with first-line chemotherapy, people can be given different treatment to try to prevent the cancer from growing again. This is called maintenance treatment. It may help people live longer. What happened in the JAVELIN Bladder 100 study? In the JAVELIN Bladder 100 study, researchers wanted to find out if maintenance treatment with avelumab would help people with advanced urothelial cancer live longer. Avelumab is a type of medicine called immunotherapy. Immunotherapy helps the body's immune system fight cancer. 700 people took part in the study. To take part, they must have already been treated with first-line chemotherapy. Also, their cancer must have shrunk or not grown with this treatment. They were then treated with either avelumab maintenance treatment plus best supportive care or best supportive care alone. Best supportive care means treatments that help improve symptoms and quality of life. These treatments do not affect the cancer directly and can include medicines to relieve pain. What were the results? Researchers found that people treated with avelumab maintenance treatment plus best supportive care lived, on average, 7 months longer than people who received best supportive care alone. People treated with avelumab had more side effects than those not treated with avelumab, but most were not severe. Common side effects with avelumab included persistent tiredness, itchy skin, urinary tract infection, and diarrhea. What do the results of the study mean? Results from the JAVELIN Bladder 100 study support the use of avelumab as maintenance treatment for people with advanced urothelial cancer whose cancer has shrunk or not grown with first-line chemotherapy. ClinicalTrials.gov NCT number: NCT02603432

Published
2022
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54. Avelumab first-line maintenance plus best supportive care (BSC) vs. BSC alone for advanced urothelial carcinoma: JAVELIN Bladder 100 Asian subgroup analysis

Author

Lee, Jae-Lyun, primary, Desai, Chirag, additional, Park, Se Hoon, additional, Tsuchiya, Norihiko, additional, Su, Po-Jung, additional, Chan, Timothy Tim Wai, additional, Gurney, Howard, additional, Gao, Seasea, additional, Wang, Jing, additional, Sandner, Robin, additional, di Pietro, Alessandra, additional, and Eto, Masatoshi, additional

Published
2023
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55. Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma: Results From the JAVELIN Bladder 100 Trial After ≥2 Years of Follow-Up

Author

Powles, Thomas, primary, Park, Se Hoon, additional, Caserta, Claudia, additional, Valderrama, Begoña P., additional, Gurney, Howard, additional, Ullén, Anders, additional, Loriot, Yohann, additional, Sridhar, Srikala S., additional, Sternberg, Cora N., additional, Bellmunt, Joaquim, additional, Aragon-Ching, Jeanny B., additional, Wang, Jing, additional, Huang, Bo, additional, Laliberte, Robert J., additional, di Pietro, Alessandra, additional, and Grivas, Petros, additional

Published
2023
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57. Supplemental figure 1 legend from Dose Escalation of Tamoxifen in Patients with Low Endoxifen Level: Evidence for Therapeutic Drug Monitoring—The TADE Study

Author

Fox, Peter, primary, Balleine, Rosemary L., primary, Lee, Clara, primary, Gao, Bo, primary, Balakrishnar, Bavanthi, primary, Menzies, Alexander M., primary, Yeap, Shang Heng, primary, Ali, Sayed Sahanawaz, primary, Gebski, Val, primary, Provan, Pamela, primary, Coulter, Sally, primary, Liddle, Christopher, primary, Hui, Rina, primary, Kefford, Richard, primary, Lynch, Jodi, primary, Wong, Mark, primary, Wilcken, Nicholas, primary, and Gurney, Howard, primary

Published
2023
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58. Supplemental figure 1 from Dose Escalation of Tamoxifen in Patients with Low Endoxifen Level: Evidence for Therapeutic Drug Monitoring—The TADE Study

Author

Fox, Peter, primary, Balleine, Rosemary L., primary, Lee, Clara, primary, Gao, Bo, primary, Balakrishnar, Bavanthi, primary, Menzies, Alexander M., primary, Yeap, Shang Heng, primary, Ali, Sayed Sahanawaz, primary, Gebski, Val, primary, Provan, Pamela, primary, Coulter, Sally, primary, Liddle, Christopher, primary, Hui, Rina, primary, Kefford, Richard, primary, Lynch, Jodi, primary, Wong, Mark, primary, Wilcken, Nicholas, primary, and Gurney, Howard, primary

Published
2023
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59. Data from Putative Biomarkers of Clinical Benefit With Pembrolizumab in Advanced Urothelial Cancer: Results from the KEYNOTE-045 and KEYNOTE-052 Landmark Trials

Author

Bellmunt, Joaquim, primary, de Wit, Ronald, primary, Fradet, Yves, primary, Climent, Miguel A., primary, Petrylak, Daniel P., primary, Lee, Jae-Lyun, primary, Fong, Lawrence, primary, Necchi, Andrea, primary, Sternberg, Cora N., primary, O'Donnell, Peter H., primary, Powles, Thomas, primary, Plimack, Elizabeth R., primary, Bajorin, Dean F., primary, Balar, Arjun V., primary, Castellano, Daniel, primary, Choueiri, Toni K., primary, Culine, Stephane, primary, Gerritsen, Winald, primary, Gurney, Howard, primary, Quinn, David I., primary, Vuky, Jacqueline, primary, Vogelzang, Nicholas J., primary, Cristescu, Razvan, primary, Lunceford, Jared, primary, Saadatpour, Assieh, primary, Loboda, Andrey, primary, Ma, Junshui, primary, Rajasagi, Mohini, primary, Godwin, James Luke, primary, Homet Moreno, Blanca, primary, and Grivas, Petros, primary

Published
2023
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60. Supplemental table S3 from Dose Escalation of Tamoxifen in Patients with Low Endoxifen Level: Evidence for Therapeutic Drug Monitoring—The TADE Study

Author

Fox, Peter, primary, Balleine, Rosemary L., primary, Lee, Clara, primary, Gao, Bo, primary, Balakrishnar, Bavanthi, primary, Menzies, Alexander M., primary, Yeap, Shang Heng, primary, Ali, Sayed Sahanawaz, primary, Gebski, Val, primary, Provan, Pamela, primary, Coulter, Sally, primary, Liddle, Christopher, primary, Hui, Rina, primary, Kefford, Richard, primary, Lynch, Jodi, primary, Wong, Mark, primary, Wilcken, Nicholas, primary, and Gurney, Howard, primary

Published
2023
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61. Supplementary Data from Putative Biomarkers of Clinical Benefit With Pembrolizumab in Advanced Urothelial Cancer: Results from the KEYNOTE-045 and KEYNOTE-052 Landmark Trials

Author

Bellmunt, Joaquim, primary, de Wit, Ronald, primary, Fradet, Yves, primary, Climent, Miguel A., primary, Petrylak, Daniel P., primary, Lee, Jae-Lyun, primary, Fong, Lawrence, primary, Necchi, Andrea, primary, Sternberg, Cora N., primary, O'Donnell, Peter H., primary, Powles, Thomas, primary, Plimack, Elizabeth R., primary, Bajorin, Dean F., primary, Balar, Arjun V., primary, Castellano, Daniel, primary, Choueiri, Toni K., primary, Culine, Stephane, primary, Gerritsen, Winald, primary, Gurney, Howard, primary, Quinn, David I., primary, Vuky, Jacqueline, primary, Vogelzang, Nicholas J., primary, Cristescu, Razvan, primary, Lunceford, Jared, primary, Saadatpour, Assieh, primary, Loboda, Andrey, primary, Ma, Junshui, primary, Rajasagi, Mohini, primary, Godwin, James Luke, primary, Homet Moreno, Blanca, primary, and Grivas, Petros, primary

Published
2023
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62. Corrigendum to “Pembrolizumab plus Olaparib in Patients with Metastatic Castration-resistant Prostate Cancer: Long-term Results from the Phase 1b/2 KEYNOTE-365 Cohort A Study” [Eur Urol 83 (2023) 15–26]

Author

Yu, Evan Y., primary, Piulats, Josep M., additional, Gravis, Gwenaelle, additional, Fong, Peter C.C., additional, Todenhöfer, Tilman, additional, Laguerre, Brigitte, additional, Arranz, Jose A., additional, Oudard, Stephane, additional, Massard, Christophe, additional, Heinzelbecker, Julia, additional, Nordquist, Luke T., additional, Carles, Joan, additional, Kolinsky, Michael P., additional, Augustin, Marinela, additional, Gurney, Howard, additional, Tafreshi, Ali, additional, Li, Xin Tong, additional, Qiu, Ping, additional, Poehlein, Christian H., additional, Schloss, Charles, additional, and de Bono, Johann S., additional

Published
2023
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64. Systemic treatment of advanced and metastatic urothelial cancer: The landscape in Australia

Author

Gurney, Howard, Clay, Timothy D., Oliveira, Niara, Wong, Shirley, Tran, Ben, Harris, Carole, Gurney, Howard, Clay, Timothy D., Oliveira, Niara, Wong, Shirley, Tran, Ben, and Harris, Carole

Abstract

The 5-year survival rate of metastatic urothelial carcinoma (mUC) is estimated to be as low as 5%. Currently, systemic platinum-based chemotherapy followed by avelumab maintenance therapy is the only first-line treatment for mUC that has an overall survival benefit. Cisplatin-based chemotherapy (usually in combination with gemcitabine) is the preferred treatment but carboplatin is substituted where contraindications to cisplatin exist. Treatment with immune checkpoint inhibitors, antibody-drug conjugates, and kinase inhibitors has not yet demonstrated superiority to chemotherapy as first-line therapy and remains investigational in this setting. A recent media release indicates that chemotherapy plus nivolumab gives an OS advantage as first-line treatment but results of this study have not yet been made public. Pembrolizumab remains an option in those having primary progression on first-line chemotherapy or within 12 months of neoadjuvant chemotherapy. The antibody-drug conjugate, enfortumab vedotin has TGA approval for patients whose cancer has progressed following chemotherapy and immunotherapy and has just received a positive Pharmaceutical Benefits Scheme recommendation. The use of molecular screens for somatic genetic mutations, gene amplifications, and protein expression is expanding as drugs that target such abnormalities show promise. However, despite these advances, a substantial proportion of patients with mUC have significant barriers to receiving any treatment, including advancing age, frailty, and comorbidities, and less toxic, effective therapies are needed.

Published
2023

66. Pembrolizumab versus placebo as post-nephrectomy adjuvant therapy for clear cell renal cell carcinoma (KEYNOTE-564): 30-month follow-up analysis of a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Author

Powles, Thomas, primary, Tomczak, Piotr, additional, Park, Se Hoon, additional, Venugopal, Balaji, additional, Ferguson, Thomas, additional, Symeonides, Stefan N, additional, Hajek, Jaroslav, additional, Gurney, Howard, additional, Chang, Yen-Hwa, additional, Lee, Jae Lyun, additional, Sarwar, Naveed, additional, Thiery-Vuillemin, Antoine, additional, Gross-Goupil, Marine, additional, Mahave, Mauricio, additional, Haas, Naomi B, additional, Sawrycki, Piotr, additional, Burgents, Joseph E, additional, Xu, Lei, additional, Imai, Kentaro, additional, Quinn, David I, additional, Choueiri, Toni K, additional, Choueiri, Toni, additional, Ferguson, Thomas R., additional, Lin, Tzu-Ping, additional, Symeonides, Stefan N., additional, Haas, Naomi B., additional, Gurney, Howard P., additional, Chevreau, Christine, additional, Burke, John M., additional, Doshi, Gurjyot, additional, Melichar, Bohuslav, additional, Topart, Delphine, additional, Oudard, Stephane, additional, Kopyltsov, Evgeniy, additional, Hammers, Hans-Joerg, additional, Quinn, David I., additional, Alva, Ajjai, additional, Menezes, Juliana de Janoski, additional, Silva, Adriano Goncalves e, additional, Winquist, Eric W., additional, Hamzaj, Alketa, additional, Procopio, Giuseppe, additional, Karaszewska, Boguslawa, additional, Nowakowska-Zajdel, Ewa M., additional, Alekseev, Boris Y., additional, Gafanov, Rustem A., additional, Izmailov, Adel, additional, Semenov, Andrey, additional, Afanasyev, Sergey G., additional, Lipatov, Oleg N., additional, Powles, Thomas B., additional, Srinivas, Sandy, additional, McDermott, David, additional, Kochuparambil, Samith T., additional, Davis, Ian D., additional, Peltola, Katriina, additional, Sabbatini, Roberto, additional, Chung, Jinsoo, additional, Shkolnik, Michail I., additional, Matveev, Vsevolod B., additional, Gajate Borau, Pablo, additional, McCune, Steven, additional, Hutson, Thomas E., additional, Dri, Alejandro, additional, Sales, Silvio Correia, additional, Yeung, Carrie, additional, Alcala Castro, Carmen Marcela, additional, Bostrom, Peter, additional, Laguerre, Brigitte, additional, Buttigliero, Consuelo, additional, de Giorgi, Ugo, additional, Fomin, Eugeniy A., additional, Zakharia, Yousef, additional, Hwang, Clara, additional, Singer, Eric A., additional, Yorio, Jeffrey T., additional, Waterhouse, David, additional, Kowalyszyn, Ruben Dario, additional, Alfie, Margarita Sonia, additional, Yanez Ruiz, Eduardo, additional, Buchler, Tomas, additional, Kankaanranta, Krista, additional, Ferretti, Gianluigi, additional, Kimura, Go, additional, Nishimura, Kazuo, additional, Masumori, Naoya, additional, Tamada, Satoshi, additional, Kato, Haruaki, additional, Kitamura, Hiroshi, additional, Danielewicz, Iwona, additional, Wojcik-Tomaszewska, Joanna, additional, Sala Gonzalez, Nuria, additional, Chiu, Kun-Yuan, additional, Atkins, Michael B., additional, Heath, Elisabeth, additional, Rojas-Uribe, Gustavo Adolfo, additional, Gonzalez Fernandez, Manuel Enrique, additional, Feyerabend, Susan, additional, Pignata, Sandro, additional, Numakura, Kazuyuki, additional, Cybulska Stopa, Bozena, additional, Zukov, Ruslan, additional, Climent Duran, Miguel Angel, additional, Maroto Rey, Pablo Jose, additional, Montesa Pino, Alvaro, additional, Chang, Chao-Hsiang, additional, Vengalil, Salil, additional, Waddell, Tom S., additional, Cobb, Patrick W., additional, Hauke, Ralph, additional, Anderson, Daniel M., additional, Sarantopoulos, John, additional, Gourdin, Theodore, additional, Zhang, Tian, additional, Jayram, Gautam, additional, Fein, Luis Enrique, additional, Harris, Carole, additional, Beato, Patricia Medeiros Milhomem, additional, Flores, Francisco, additional, Estay, Angela, additional, Rubiano, Juan Andres, additional, Bedke, Jens, additional, Hauser, Stefan, additional, Neisius, Andreas, additional, Busch, Jonas, additional, Anai, Satoshi, additional, Tsunemori, Hiroyuki, additional, Sawka, Dariusz, additional, Sikora-Kupis, Bozena, additional, Arranz, Jose Angel, additional, Delgado, Ignacio, additional, Chen, Chung-Hsin, additional, Gunderson, Elizabeth, additional, Tykodi, Scott, additional, Koletsky, Alan, additional, Chen, Kevin, additional, Agrawal, Manish, additional, Kaen, Diego Lucas, additional, Sade, Juan Pablo, additional, Tatangelo, Marcelo Daniel, additional, Parnis, Francis, additional, Barbosa, Fernando Maciel, additional, Faucher, Genevieve, additional, Iqbal, Nayyer, additional, Marceau, Daniele, additional, Paradis, Jean-Benoit, additional, Hanna, Nawar, additional, Acevedo, Alejandro, additional, Ibanez, Carolina, additional, Villanueva, Luis, additional, Galaz, Pedro Pablo, additional, Durango, Isabel Cristina, additional, Manneh, Ray, additional, Kral, Zdenek -, additional, Holeckova, Petra, additional, Hakkarainen, Heikki, additional, Ronkainen, Hanna, additional, Abadie-Lacourtoisie, Sophie, additional, Tartas, Sophie, additional, Goebell, Peter J., additional, Grimm, Marc-Oliver, additional, Hoefner, Thomas, additional, Wirth, Manfred, additional, Panic, Andrej, additional, Schultze-Seemann, Wolfgang, additional, Yokomizo, Akira, additional, Mizuno, Ryuichi, additional, Uemura, Hirotsugu, additional, Eto, Masatoshi, additional, Tsujihata, Masao, additional, Matsukawa, Yoshihisa, additional, Murakami, Yoji, additional, Kim, Miso, additional, Hamberg, Paul, additional, Marczewska-Skrodzka, Malgorzata, additional, Szczylik, Cezary, additional, Humphreys, Alison C., additional, Jiang, Peter, additional, Kumar, Birendra, additional, Lu, Gary, additional, Desai, Arpita, additional, Karam, Jose Antonio, additional, Keogh, George, additional, Fleming, Mark, additional, Zarba, Juan Jose, additional, Leiva, Viviana E., additional, Mendez, Guillermo Ariel, additional, Harris, Samuel J., additional, Brown, Stephen J., additional, Antonio Junior, Joao Neif, additional, Costamilan, Rita de Cassia, additional, Rocha, Roberto Odebrecht, additional, Muniz, David, additional, Brust, Leandro, additional, Lalani, Aly-Khan, additional, Graham, Jeffrey, additional, Levesque, Michael, additional, Orlandi, Francisco, additional, Kotasek, Rostislav, additional, Deville, Jean L., additional, Borchiellini, Delphine, additional, Merseburger, Axel, additional, Rink, Michael, additional, Roos, Frederik, additional, McDermott, Ray, additional, Oyama, Masafumi, additional, Yamamoto, Yoshiaki, additional, Tomita, Yoshihiko, additional, Miura, Yuji, additional, Ioritani, Naomasa, additional, Westgeest, Hans, additional, Kubiatowski, Tomasz, additional, Bal, Wieslaw, additional, Girones Sarrio, Regina, additional, Rowe, Julie, additional, Prow, Debra M., additional, Senecal, Francis, additional, Hashemi-Sadraei, Neda, additional, Cole, Scott W., additional, Kendall, Stephan D., additional, Richards, Donald A., additional, Schnadig, Ian D., additional, and Gupta, Mukul, additional

Published
2022
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69. Efficacy and safety of lenvatinib plus pembrolizumab vs sunitinib in the East Asian subset of patients with advanced renal cell carcinoma from the CLEAR trial.

Author

Rha, Sun Young, Choueiri, Toni K., Matveev, Vsevolod B., Alyasova, Anna, Hong, Sung‐Hoo, Gordoa, Teresa Alonso, Gurney, Howard, Bjarnason, Georg A., Buchler, Tomas, Pedrazzoli, Paolo, Takagi, Toshio, Park, Se Hoon, Lee, Jae Lyun, Perini, Rodolfo F., He, Cixin S., McKenzie, Jodi A., and Eto, Masatoshi

Subjects
SUNITINIB, HAND-foot syndrome, RENAL cell carcinoma, PEMBROLIZUMAB, PROTEIN-tyrosine kinase inhibitors, PLATELET count, PATIENT safety
Abstract

In the CLEAR trial, lenvatinib plus pembrolizumab met study endpoints of superiority vs sunitinib in the first‐line treatment of patients with advanced renal cell carcinoma. We report the efficacy and safety results of the East Asian subset (ie, patients in Japan and the Republic of Korea) from the CLEAR trial. Of 1069 patients randomly assigned to receive either lenvatinib plus pembrolizumab, lenvatinib plus everolimus or sunitinib, 213 (20.0%) were from East Asia. Baseline characteristics of patients in the East Asian subset were generally comparable with those of the global trial population. In the East Asian subset, progression‐free survival was considerably longer with lenvatinib plus pembrolizumab vs sunitinib (median 22.1 vs 11.1 months; HR 0.38; 95% CI: 0.23‐0.62). The HR for overall survival comparing lenvatinib plus pembrolizumab vs sunitinib was 0.71; 95% CI: 0.30‐1.71. The objective response rate was higher with lenvatinib plus pembrolizumab vs sunitinib (65.3% vs 49.2%; odds ratio 2.14; 95% CI: 1.07‐4.28). Dose reductions due to treatment‐emergent adverse events (TEAEs) commonly associated with tyrosine kinase inhibitors occurred more frequently than in the global population. Hand‐foot syndrome was the most frequent any‐grade TEAE with lenvatinib plus pembrolizumab (66.7%) and sunitinib (57.8%), a higher incidence compared to the global population (28.7% and 37.4%, respectively). The most common grade 3 to 5 TEAEs were hypertension with lenvatinib plus pembrolizumab (20%) and decreased platelet count with sunitinib (21.9%). Efficacy and safety for patients in the East Asian subset were generally similar to those of the global population, except as noted. [ABSTRACT FROM AUTHOR]

Published
2023
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70. Pembrolizumab plus docetaxel for patients with metastatic castration-resistant prostate cancer (mCRPC): Randomized, double-blind, phase 3 KEYNOTE-921 study.

Author

Petrylak, Daniel P., primary, Ratta, Raffaele, additional, Matsubara, Nobuaki, additional, Korbenfeld, Ernesto Pablo, additional, Gafanov, Rustem, additional, Mourey, Loic, additional, Todenhöfer, Tilman, additional, Gurney, Howard, additional, Kramer, Gero, additional, Bergman, Andre M., additional, Zalewski, Pawel, additional, De Santis, Maria, additional, Armstrong, Andrew J., additional, Gerritsen, Winald R., additional, Pachynski, Russell Kent, additional, Byun, Seok-Soo, additional, Li, Xin Tong, additional, Schloss, Charles, additional, Poehlein, Christian Heinrich, additional, and Fizazi, Karim, additional

Published
2023
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71. Nivolumab plus cabozantinib vs sunitinib for first-line treatment of advanced renal cell carcinoma (aRCC): 3-year follow-up from the phase 3 CheckMate 9ER trial.

Author

Burotto, Mauricio, primary, Powles, Thomas, additional, Escudier, Bernard, additional, Apolo, Andrea B., additional, Bourlon, Maria Teresa, additional, Shah, Amishi Yogesh, additional, Suárez, Cristina, additional, Porta, Camillo, additional, Barrios, Carlos H., additional, Richardet, Martin, additional, Gurney, Howard, additional, Kessler, Elizabeth R, additional, Tomita, Yoshihiko, additional, Bedke, Jens, additional, George, Saby, additional, Scheffold, Christian, additional, Wang, Peter, additional, Fedorov, Viktor, additional, Motzer, Robert J., additional, and Choueiri, Toni K., additional

Published
2023
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72. Niraparib (NIRA) with abiraterone acetate and prednisone (AAP) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alterations: Second interim analysis (IA2) of MAGNITUDE.

Author

Efstathiou, Eleni, primary, Smith, Matthew Raymond, additional, Sandhu, Shahneen, additional, Attard, Gerhardt, additional, Saad, Marniza, additional, Olmos, David, additional, Castro, Elena, additional, Roubaud, Guilhem, additional, Gomes, Andrea Juliana, additional, Small, Eric Jay, additional, Rathkopf, Dana E., additional, Gurney, Howard, additional, Jung, Wonho, additional, Mason, Gary, additional, Francis, Peter St. John, additional, Wang, George C., additional, Wu, Daphne, additional, Diorio, Brooke, additional, Lopez- Gitlitz, Angela Mennicke, additional, and Chi, Kim N., additional

Published
2023
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74. Outcomes by IMDC risk in the COSMIC-313 phase 3 trial evaluating cabozantinib (C) plus nivolumab (N) and ipilimumab (I) in first-line advanced RCC (aRCC) of IMDC intermediate or poor risk.

Author

Powles, Thomas, primary, Motzer, Robert J., additional, Albiges, Laurence, additional, Suárez, Cristina, additional, Schutz, Fabio A. B., additional, Heng, Daniel Yick Chin, additional, Chevreau, Christine, additional, Kanesvaran, Ravindran, additional, Gurney, Howard, additional, Wang, Fong, additional, Mataveli, Fabio, additional, Chang, Yu-Lin, additional, van Kooten Losio, Maximiliano, additional, and Choueiri, Toni K., additional

Published
2023
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75. Patient-reported outcomes (PROs) in KEYNOTE-921: Pembrolizumab (pembro) plus docetaxel for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).

Author

Petrylak, Daniel P., primary, Ratta, Raffaele, additional, Matsubara, Nobuaki, additional, Korbenfeld, Ernesto Pablo, additional, Gafanov, Rustem, additional, Mourey, Loic, additional, Todenhöfer, Tilman, additional, Gurney, Howard, additional, Kramer, Gero, additional, Bergman, Andre M., additional, Zalewski, Pawel, additional, De Santis, Maria, additional, Armstrong, Andrew J., additional, Gerritsen, Winald R., additional, Pachynski, Russell Kent, additional, Saretsky, Todd L., additional, Ghate, Sameer R., additional, Li, Xin Tong, additional, Schloss, Charles, additional, and Fizazi, Karim, additional

Published
2023
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77. FORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1/3 mRNA Expression

Author

Sternberg, Cora N., primary, Petrylak, Daniel P., additional, Bellmunt, Joaquim, additional, Nishiyama, Hiroyuki, additional, Necchi, Andrea, additional, Gurney, Howard, additional, Lee, Jae-Lyun, additional, van der Heijden, Michiel S., additional, Rosenbaum, Eli, additional, Penel, Nicolas, additional, Pang, See-Tong, additional, Li, Jian-Ri, additional, García del Muro, Xavier, additional, Joly, Florence, additional, Pápai, Zsuzsanna, additional, Bao, Weichao, additional, Ellinghaus, Peter, additional, Lu, Chengxing, additional, Sierecki, Mitchell, additional, Coppieters, Sabine, additional, Nakajima, Keiko, additional, Ishida, Tatiane Cristine, additional, and Quinn, David I., additional

Published
2023
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78. French of the JAVELIN Bladder 100 study: avelumab maintenance treatment for advanced urothelial cancer

Author

Powles, Thomas, Hoon Park, Se, Voog, Eric, Caserta, Claudia, Valderrama, Begoña P., Gurney, Howard, Kalofonos, Haralabos, Radulovic, Sinisa, Demey, Wim, Ullén, Anders, Loriot, Yohann, Sridhar, Srikala S., Tsuchiya, Norihiko, Kopyltsov, Evgeny, Sternberg, Cora N., Bellmunt, Joaquim, Aragon-Ching, Jeanny B., Petrylak, Daniel P., Laliberte, Robert J., Huang, Bo, Costa, Nuno, Blake-Haskins, John A., and Grivas, Petros

Subjects
Cancer therapy (excl. chemotherapy and radiation therapy)
Abstract

French Translation

Published
2023
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81. Modulation of Plasma Lipidomic Profiles in Metastatic Castration-Resistant Prostate Cancer by Simvastatin

Author

Mak, Blossom, primary, Lin, Hui-Ming, additional, Duong, Thy, additional, Mahon, Kate L., additional, Joshua, Anthony M., additional, Stockler, Martin R., additional, Gurney, Howard, additional, Parnis, Francis, additional, Zhang, Alison, additional, Scheinberg, Tahlia, additional, Wittert, Gary, additional, Butler, Lisa M., additional, Sullivan, David, additional, Hoy, Andrew J., additional, Meikle, Peter J., additional, and Horvath, Lisa G., additional

Published
2022
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85. Characterising men experiencing cognitive side-effects from hormone therapy: a systematic scoping review

Author

Huang, Lorna, Sherman, Kerry, Francis, Heather, Dhillon, Haryana, and Gurney, Howard

Subjects
hormone therapy, cognitive problems, Medicine and Health Sciences, Androgen deprivation therapy, prostate cancer, cognitive impairment
Abstract

A scoping review was conducted in order to systematically map the research surrounding hormone therapy and cognition, as well as to identify any existing gaps in knowledge. The following research question was formulated: what is known from the literature about the characteristics of men with prostate cancer experiencing cognitive side-effects from hormone therapy? The characteristics extracted from the literature were analysed using the biopsychosocial approach to identify the sociodemographic, medical, interpersonal and intrapersonal factors.

Published
2022
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87. Long-term outcomes in patients with advanced urothelial carcinoma (UC) who received avelumab first-line (1L) maintenance with or without second-line (2L) treatment: Exploratory analyses from JAVELIN Bladder 100.

Author

Bellmunt, Joaquim, primary, Powles, Thomas, additional, Climent Duran, Miguel Angel, additional, Sridhar, Srikala S., additional, Gurney, Howard, additional, Costa, Nuno, additional, Di Pietro, Alessandra, additional, Huang, Bo, additional, Gupta, Shilpa, additional, and Grivas, Petros, additional

Published
2022
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88. Patient-reported Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Harboring DNA Damage Response Alterations Treated with Talazoparib: Results from TALAPRO-1

Author

Saad, Fred, primary, de Bono, Johann, additional, Barthélémy, Philippe, additional, Dorff, Tanya, additional, Mehra, Niven, additional, Scagliotti, Giorgio, additional, Stirling, Adam, additional, Machiels, Jean-Pascal, additional, Renard, Vincent, additional, Maruzzo, Marco, additional, Higano, Celestia S., additional, Gurney, Howard, additional, Healy, Cynthia, additional, Bhattacharyya, Helen, additional, Arondekar, Bhakti, additional, Niyazov, Alexander, additional, and Fizazi, Karim, additional

Published
2022
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89. Adjuvant pembrolizumab for postnephrectomy renal cell carcinoma (RCC): Expanded efficacy analyses from KEYNOTE-564.

Author

Choueiri, Toni K., primary, Tomczak, Piotr, additional, Park, Se Hoon, additional, Venugopal, Balaji, additional, Ferguson, Tom, additional, Symeonides, Stefan N., additional, Hajek, Jaroslav, additional, Chang, Yen-Hwa, additional, Lee, Jae-Lyun, additional, Sarwar, Naveed, additional, Thiery-Vuillemin, Antoine, additional, Gross-Goupil, Marine, additional, Mahave, Mauricio, additional, Haas, Naomi B., additional, Sawrycki, Piotr, additional, Gurney, Howard, additional, Xu, Lei, additional, Imai, Kentaro, additional, Rogerio, Jackie, additional, and Powles, Thomas, additional

Published
2022
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91. Patient-reported Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Harboring DNA Damage Response Alterations Treated with Talazoparib: Results from TALAPRO-1.

Author

UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Centre du cancer, UCL - (SLuc) Unité d'oncologie médicale, UCL - (SLuc) Service d'oto-rhino-laryngologie, Saad, Fred, de Bono, Johann, Barthélémy, Philippe, Dorff, Tanya, Mehra, Niven, Scagliotti, Giorgio, Stirling, Adam, Machiels, Jean-Pascal, Renard, Vincent, Maruzzo, Marco, Higano, Celestia S, Gurney, Howard, Healy, Cynthia, Bhattacharyya, Helen, Arondekar, Bhakti, Niyazov, Alexander, Fizazi, Karim, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Centre du cancer, UCL - (SLuc) Unité d'oncologie médicale, UCL - (SLuc) Service d'oto-rhino-laryngologie, Saad, Fred, de Bono, Johann, Barthélémy, Philippe, Dorff, Tanya, Mehra, Niven, Scagliotti, Giorgio, Stirling, Adam, Machiels, Jean-Pascal, Renard, Vincent, Maruzzo, Marco, Higano, Celestia S, Gurney, Howard, Healy, Cynthia, Bhattacharyya, Helen, Arondekar, Bhakti, Niyazov, Alexander, and Fizazi, Karim

Abstract

Talazoparib has shown antitumor activity with a manageable safety profile in men with metastatic castration-resistant prostate cancer (mCRPC) and DNA damage response (DDR)/homologous recombination repair (HRR) alterations. To evaluate patient-reported health-related quality of life (HRQoL) and pain in patients who received talazoparib in the TALAPRO-1 study, with a special interest in patients harboring breast cancer susceptibility gene 1 or 2 (BRCA1/2) mutations. TALAPRO-1 is a single-arm, phase 2 study in men with mCRPC DDR alterations either directly or indirectly involved in HRR, who previously received one to two taxane-based chemotherapy regimens for advanced prostate cancer and whose mCRPC progressed on one or more novel hormonal agents. Men completed the European Quality-of-life Five-dimension Five-level scale (EQ-5D-5L), EQ-5D visual analog scale (VAS), and Brief Pain Inventory-Short Form at predefined time points during the study. The patient-reported outcome (PRO) population included men who completed a baseline and one or more postbaseline assessments before study end. Longitudinal mixed-effect models assuming an unstructured covariance matrix were used to estimate the mean (95% confidence interval [CI]) change from baseline for pain and general health status measurements among all patients and patients with BRCA1/2 mutations. In the 97 men in the PRO population treated with talazoparib (BRCA1/2, n = 56), the mean (95% CI) EQ-5D-5L Index improved (all patients, 0.05 [0.01, 0.08]; BRCA1/2 subset, 0.07 [0.03, 0.10]), as did the EQ-5D VAS scores (all patients, 5.42 [2.65, 8.18]; BRCA1/2 subset, 4.74 [1.07, 8.41]). Improvements in the estimated overall change from baseline (95% CI) in the mean worst pain were observed in all patients (-1.08 [-1.52, -0.65]) and the BRCA1/2 subset (-1.15 [-1.67, -0.62]). The probability of not having had experienced deterioration of worst pain by month 12 was 84% for all patients and 83% for the BRCA1/2 subset. In heavily pret

Published
2022

93. Five‐year survival and clinical correlates among patients with advanced non‐small cell lung cancer, melanoma and renal cell carcinoma treated with immune check‐point inhibitors in Australian tertiary oncology centres.

Author

Brown, Lauren J, da Silva, Ines Pires, Moujaber, Tania, Gao, Bo, Hui, Rina, Gurney, Howard, Carlino, Matteo, and Nagrial, Adnan

Subjects
NON-small-cell lung carcinoma, IMMUNE checkpoint inhibitors, RENAL cell carcinoma, DRUG side effects, IPILIMUMAB, ONCOLOGY
Abstract

Aims: There is robust trial evidence for improved overall survival (OS) with immunotherapy in advanced solid organ malignancies. The real‐world long‐term survival data and the predictive variables are not yet known. Our aim was to evaluate factors associated with 3‐year and 5‐year OS for patients treated with immune checkpoint inhibitors (ICIs). Methods: We performed a retrospective study of patients who received ICIs as management of advanced solid organ malignancies in two tertiary Australian oncology centres from 2012–2017. Data pertaining to clinical characteristics, metastatic disease burden, immune‐related adverse events (IRAEs) and tumour responses were collected and their relationship to survival examined. Results: In this analysis of 264 patients, 202 (76.5%) had melanoma, 46 (17.4%) had non‐small cell lung cancer (NSCLC), 12 (4.5%) had renal cell carcinoma (RCC) and 4 (1.5%) had mesothelioma. The 5‐year OS rates were 42.1% in patients with melanoma, 19.6% with NSCLC, 75% with RCC, and none of the mesothelioma patients were alive at 5 years. In multivariate analysis, an ECOG score of 0 (Hazard ratio [HR] 0.39; 95% confidence interval [CI] 0.23–0.66; p < 0.001) and the occurrence of IRAE's of any grade (HR 0.61; 95% CI 0.37–0.95; p = 0.05) were associated with better 5‐year survival. The presence of bone metastases (HR 1.62; 95% CI 1.03–2.82; p = 0.05) and liver metastases (HR 1.76; 95% CI 1.07–2.89; p = 0.03) were associated with worse 5‐year survival. Conclusions: These results support the long‐term benefits of immunotherapy that in some patients, extend to at least 5 years. ECOG performance status of 0 and the occurrence of irAEs are associated with better long‐term survival. Survival is significantly influenced by metastatic site and cancer type. These predictive clinical correlates aid discussions and planning in the delivery of ICIs to patients. [ABSTRACT FROM AUTHOR]

Published
2023
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94. PD10-02 AVELUMAB FIRST-LINE MAINTENANCE FOR ADVANCED UROTHELIAL CARCINOMA: LONG-TERM FOLLOW-UP RESULTS FROM THE JAVELIN BLADDER 100 TRIAL

Author

Grivas, Petros, primary, Bellmunt, Joaquim, additional, Park, Se Hoon, additional, Voog, Eric, additional, Caserta, Claudia, additional, Valderrama, Begoña P., additional, Gurney, Howard, additional, Loriot, Yohann, additional, Sridhar, Srikala S., additional, Tsuchiya, Norihiko, additional, Sternberg, Cora N., additional, Aragon-Ching, Jeanny B., additional, Petrylak, Daniel P., additional, Blake-Haskins, John A., additional, Laliberte, Robert J., additional, Wang, Jing, additional, Costa, Nuno, additional, and Powles, Thomas, additional

Published
2022
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95. Conditional survival and long‐term efficacy with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma

Author

Motzer, Robert J., primary, McDermott, David F., additional, Escudier, Bernard, additional, Burotto, Mauricio, additional, Choueiri, Toni K., additional, Hammers, Hans J., additional, Barthélémy, Philippe, additional, Plimack, Elizabeth R., additional, Porta, Camillo, additional, George, Saby, additional, Powles, Thomas, additional, Donskov, Frede, additional, Gurney, Howard, additional, Kollmannsberger, Christian K., additional, Grimm, Marc‐Oliver, additional, Barrios, Carlos, additional, Tomita, Yoshihiko, additional, Castellano, Daniel, additional, Grünwald, Viktor, additional, Rini, Brian I., additional, McHenry, M. Brent, additional, Lee, Chung‐Wei, additional, McCarthy, Jennifer, additional, Ejzykowicz, Flavia, additional, and Tannir, Nizar M., additional

Published
2022
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97. Putative Biomarkers of Clinical Benefit With Pembrolizumab in Advanced Urothelial Cancer: Results from the KEYNOTE-045 and KEYNOTE-052 Landmark Trials

Author

Bellmunt, Joaquim, primary, de Wit, Ronald, additional, Fradet, Yves, additional, Climent, Miguel A., additional, Petrylak, Daniel P., additional, Lee, Jae-Lyun, additional, Fong, Lawrence, additional, Necchi, Andrea, additional, Sternberg, Cora N., additional, O'Donnell, Peter H., additional, Powles, Thomas, additional, Plimack, Elizabeth R., additional, Bajorin, Dean F., additional, Balar, Arjun V., additional, Castellano, Daniel, additional, Choueiri, Toni K., additional, Culine, Stephane, additional, Gerritsen, Winald, additional, Gurney, Howard, additional, Quinn, David I., additional, Vuky, Jacqueline, additional, Vogelzang, Nicholas J., additional, Cristescu, Razvan, additional, Lunceford, Jared, additional, Saadatpour, Assieh, additional, Loboda, Andrey, additional, Ma, Junshui, additional, Rajasagi, Mohini, additional, Godwin, James Luke, additional, Homet Moreno, Blanca, additional, and Grivas, Petros, additional

Published
2022
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99. First-line Nivolumab plus Ipilimumab Versus Sunitinib in Patients Without Nephrectomy and With an Evaluable Primary Renal Tumor in the CheckMate 214 Trial

Author

Albiges, Laurence, primary, Tannir, Nizar M., additional, Burotto, Mauricio, additional, McDermott, David, additional, Plimack, Elizabeth R., additional, Barthélémy, Philippe, additional, Porta, Camillo, additional, Powles, Thomas, additional, Donskov, Frede, additional, George, Saby, additional, Kollmannsberger, Christian K., additional, Gurney, Howard, additional, Grimm, Marc-Oliver, additional, Tomita, Yoshihiko, additional, Castellano, Daniel, additional, Rini, Brian I., additional, Choueiri, Toni K., additional, Leung, David, additional, Saggi, Shruti Shally, additional, Lee, Chung-Wei, additional, McHenry, M. Brent, additional, and Motzer, Robert J., additional

Published
2022
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100. Niraparib in patients with metastatic castration-resistant prostate cancer and DNA repair gene defects (GALAHAD): a multicentre, open-label, phase 2 trial

Author

Smith, Matthew R, primary, Scher, Howard I, additional, Sandhu, Shahneen, additional, Efstathiou, Eleni, additional, Lara, Primo N, additional, Yu, Evan Y, additional, George, Daniel J, additional, Chi, Kim N, additional, Saad, Fred, additional, Ståhl, Olof, additional, Olmos, David, additional, Danila, Daniel C, additional, Mason, Gary E, additional, Espina, Byron M, additional, Zhao, Xin, additional, Urtishak, Karen A, additional, Francis, Peter, additional, Lopez-Gitlitz, Angela, additional, Fizazi, Karim, additional, Parnis, Francis, additional, Joshua, Anthony M., additional, Horvath, Lisa G., additional, Steer, Christopher, additional, Marx, Gavin, additional, Gurney, Howard, additional, Ferguson, Thomas, additional, Van Bruwaene, Siska, additional, Luyten, Daisy, additional, Schatteman, Peter, additional, Lumen, Nicolaas, additional, Dirix, Luc, additional, Goeminne, Jean-Charles, additional, Gil, Thierry, additional, Seront, Emmanuel, additional, Vulsteke, Christof, additional, Kussumoto, Celio, additional, Franke, Fabio A., additional, Martinelli de Oliveira, Fabricio Augusto, additional, Pereira de Santana Gomes, Andrea Juliana, additional, Pinczowski, Hélio, additional, Preto, Daniel D'Almeida, additional, Zucca, Luis Eduardo, additional, Borges, Giuliano Santos, additional, Murad, Andre M., additional, Chi, Kim N., additional, Fradet, Yves, additional, Fleshner, Neil E., additional, Emmenegger, Urban, additional, Brasso, Klaus, additional, Culine, Stephane, additional, Thiery-Vuillemin, Antoine, additional, Joly, Florence, additional, Fléchon, Aude, additional, Hilgers, Werner, additional, Eymard, Jean-Christophe, additional, Borchiellini, Delphine, additional, Barthélémy, Philippe, additional, Berger, Raanan, additional, Leibowitz-Amit, Raya, additional, Mermershtain, Wilmosh, additional, Rouvinov, Keren, additional, Peer, Avivit, additional, Kovel, Svetlana, additional, Sella, Avishay, additional, Lolkema, Martijn P., additional, van den Eertwegh, Alfonsus J.M., additional, Voortman, Johannes, additional, Aarts, Maureen J., additional, Gietema, Jourik A., additional, Kim, Choung-Soo, additional, Choi, Young-Deuk, additional, Chung, Byung-Ha, additional, Gafanov, Rustem A., additional, Kopyltsov, Evgeniy, additional, Usynin, Evgeny A., additional, Carles, Joan, additional, Mellado, Begoña, additional, Maroto, José Pablo, additional, García-Donás, Jesús, additional, Rodríguez Moreno, Juan Francisco, additional, Durán, Ignacio, additional, Pérez-Valderrama, Begoña, additional, Castro, Elena, additional, Méndez-Vidal, María José, additional, Estellés, David Lorente, additional, Sarrió, Regina Gironés, additional, Muñoz-Langa, José, additional, Herranz, Urbano Anido, additional, Puente Vázquez, Javier, additional, Castellanos, Enrique, additional, Hellström, Martin, additional, Widmark, Anders, additional, Lissbrant, Ingela Franck, additional, Jellvert, Åsa, additional, Külich, Cecilia, additional, Blom, René, additional, Chiang, Po-Hui, additional, Kang, Chih-Hsiung, additional, Ou, Yen-Chuan, additional, Wang, Shian-Shiang, additional, Wu, Hsi-Chin, additional, Lu, Yu-Chuan, additional, Attard, Gerhardt, additional, Khoo, Vincent, additional, Bahl, Amit, additional, Kellati, Prasad, additional, Parikh, Omi, additional, Srinivasan, Rajaguru, additional, Lester, Jason F., additional, Staffurth, John N., additional, Cheng, Heather H., additional, Pilié, Patrick G., additional, George, Daniel J., additional, Karsh, Lawrence I., additional, Kelly, W. Kevin, additional, Danila, Daniel C., additional, Sieber, Paul R., additional, Smith, Matthew R., additional, Heath, Elisabeth I., additional, Vaishampayan, Ulka N., additional, Flaig, Thomas W., additional, Emamekhoo, Hamid, additional, Pinski, Jacek K., additional, Kalebasty, Arash Rezazadeh, additional, Maly, Joseph J., additional, and Moon, Helen, additional

Published
2022
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