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1. A phase 1/2 clinical trial of invariant natural killer T cell therapy in moderate-severe acute respiratory distress syndrome

Author

Hammond, Terese C., Purbhoo, Marco A., Kadel, Sapana, Ritz, Jerome, Nikiforow, Sarah, Daley, Heather, Shaw, Kit, van Besien, Koen, Gomez-Arteaga, Alexandra, Stevens, Don, Ortuzar, Waldo, Michelet, Xavier, Smith, Rachel, Moskowitz, Darrian, Masakayan, Reed, Yigit, Burcu, Boi, Shannon, Soh, Kah Teong, Chamberland, John, Song, Xin, Qin, Yu, Mishchenko, Ilya, Kirby, Maurice, Nasonenko, Valeriia, Buffa, Alexa, Buell, Jennifer S., Chand, Dhan, van Dijk, Marc, Stebbing, Justin, and Exley, Mark A.

Published
2024
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2. Omission of Radiotherapy in Primary Mediastinal B-Cell Lymphoma: IELSG37 Trial Results

Author

Martelli, Maurizio, Ceriani, Luca, Ciccone, Giovannino, Ricardi, Umberto, Kriachok, Iryna, Botto, Barbara, Balzarotti, Monica, Tucci, Alessandra, Usai, Sara Veronica, Zilioli, Vittorio Ruggero, Pennese, Elsa, Arcaini, Luca, Dabrowska-Iwanicka, Anna, Ferreri, Andrés J.M., Merli, Francesco, Zhao, Weili, Rigacci, Luigi, Cellini, Claudia, Hodgson, David, Ionescu, Codruta, Minoia, Carla, Lucchini, Elisa, Spina, Michele, Fosså, Alexander, Janikova, Andrea, Cwynarski, Kate, Mikhaeel, George, Jerkeman, Mats, Di Rocco, Alice, Stepanishyna, Yana, Vitolo, Umberto, Santoro, Armando, Re, Alessandro, Puccini, Benedetta, Olivieri, Jacopo, Petrucci, Luigi, Barrington, Sally F., Malkowski, Bogdan, Metser, Ur, Versari, Annibale, Chauvie, Stephane, Walewski, Jan, Trneny, Marek, Cavalli, Franco, Gospodarowicz, Mary, Johnson, Peter W.M., Davies, Andrew, Zucca, Emanuele, Gospodarowicz, Mary, Hodgson, David, Kuruvilla, John, Wang, Li, Zhao, Weili, Balada, David, Huettmann, Andreas, Angrilli, Francesco, Annibali, Ombretta, Arcaini, Luca, Bagni, Oreste, Balzarotti, Monica, Battistini, Roberta, Botto, Barbara, Cabras, Maria Giuseppina, Calimeri, Teresa, Catello, Califano, Cavallo, Federica, Cellini, Claudia, Ciammella, Patrizia, Consoli, Ugo, De Sanctis, Vitaliana, Di Renzo, Nicola, Di Rocco, Alice, Fabbri, Alberto, Ferrari, Angela, Ferreri, Andrés J.M., Flenghi, Leonardo, Gaidano, Gianluca, Gini, Guido, Gotti, Manuel, Guarini, Attilio, Liberati, Anna Marina, Lucchini, Elisa, Mannina, Donato, Martelli, Maurizio, Matrone, Fabio, Merli, Francesco, Minoia, Carla, Molinari, Anna Lia, Musuraca, Gerardo, Nassi, Luca, Olivieri, Jacopo, Passamonti, Francesco, Pastore, Domenico, Patti, Caterina, Pelliccia, Sabrina, Pennese, Elsa, Petrucci, Luigi, Piazza, Francesco, Pisani, Francesco, Pizzuti, Michele, Pozzi, Samantha, Puccini, Benedetta, Ravano, Emanuele, Re, Alessandro, Re, Francesca, Rigacci, Luigi, Santoro, Armando, Sassone, Marianna, Spina, Michele, Stefoni, Vittorio, Stelitano, Caterina, Tarantini, Giuseppe, Tarella, Corrado, Tucci, Alessandra, Usai, Sara Veronica, Vallisa, Daniele, Vitolo, Umberto, Zaja, Francesco, Zanni, Manuela, Zilioli, Vittorio Ruggero, Fagerli, Un Merete, Fosså, Alexander, Dabrowska-Iwanicka, Anna, Walewski, Jan, DaSilva, Maria Gomes, Jerkeman, Mats, Azinwi, Ngwa Che, Cavalli, Franco, Deantonio, Letizia, Hitz, Felicitas, Ionescu, Codruta, Mingrone, Walter, Moccia, Alden, Novak, Urban, Pirosa, Maria Cristina, Stathis, Anastasios, Zucca, Emanuele, Kriachok, Iryna, Stepanishyna, Yana, Cozens, Kelly, Cwynarski, Kate, Davies, Andrew, Fox, Christopher P., Illidge, Timothy, Johnson, Rod, McKay, Pam, Mikhaeel, George, Milne, Alison, Nimish, Shah, Osborne, Wendy, Paneesha, Shankara, Pettitt, Andrew, Stevens, Don Ambrose, Barrington, Sally F., Stephane Chauvie Bogdan Malkowski, Luca Ceriani, Metser, Ur, Versari, Annibale, Bonomini, Luisella, and Ielmini, Nicoletta

Published
2024
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4. Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results

Author

Lesokhin, Alexander M., Tomasson, Michael H., Arnulf, Bertrand, Bahlis, Nizar J., Miles Prince, H., Niesvizky, Ruben, Rodrίguez-Otero, Paula, Martinez-Lopez, Joaquin, Koehne, Guenther, Touzeau, Cyrille, Jethava, Yogesh, Quach, Hang, Depaus, Julien, Yokoyama, Hisayuki, Gabayan, Afshin Eli, Stevens, Don A., Nooka, Ajay K., Manier, Salomon, Raje, Noopur, Iida, Shinsuke, Raab, Marc-Steffen, Searle, Emma, Leip, Eric, Sullivan, Sharon T., Conte, Umberto, Elmeliegy, Mohamed, Czibere, Akos, Viqueira, Andrea, and Mohty, Mohamad

Published
2023
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7. Venetoclax combinations delay the time to deterioration of HRQoL in unfit patients with acute myeloid leukemia

Author

Pratz, Keith W, Panayiotidis, Panayiotis, Recher, Christian, Wei, Xudong, Jonas, Brian A, Montesinos, Pau, Ivanov, Vladimir, Schuh, Andre C, DiNardo, Courtney D, Novak, Jan, Pejsa, Vlatko, Stevens, Don, Yeh, Su-Peng, Kim, Inho, Turgut, Mehmet, Fracchiolla, Nicola, Yamamoto, Kazuhito, Ofran, Yishai, Wei, Andrew H, Bui, Cat N, Benjamin, Katy, Kamalakar, Rajesh, Potluri, Jalaja, Mendes, Wellington, Devine, Jacob, and Fiedler, Walter

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Clinical Research, Rare Diseases, Cancer, Antineoplastic Combined Chemotherapy Protocols, Bridged Bicyclo Compounds, Heterocyclic, Cytarabine, Fatigue, Humans, Leukemia, Myeloid, Acute, Quality of Life, Sulfonamides, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology, Oncology and carcinogenesis
Abstract

Phase 3 trials Viale-A and Viale-C evaluated health-related quality of life (HRQoL) in patients with AML unfit for intensive chemotherapy who received venetoclax (VEN) + (AZA) (Viale-A) or low-dose cytarabine (LDAC) (Viale-C) or placebo (PBO) + AZA or LDAC. Patient-reported outcomes included: EORTC QLQ-C30 global health status (GHS/QoL) and physical functioning (PF), PROMIS Cancer Fatigue Short Form 7a (Fatigue), and EQ-5D-5L health status visual analog scale (HS-VAS). Time to deterioration (TTD), defined as worsening from baseline in meaningful change thresholds (MCT) of ≥10, 5, or 7 points for GHS/QoL or PF, fatigue, and HS-VAS, respectively, was assessed; differences between groups were analyzed using Kaplan-Meier and unadjusted log-rank analyses. VEN + AZA vs PBO + AZA patients had longer TTD in GHS/QoL (P = 0.066) and fatigue (P = 0.189), and significantly longer TTD in PF (P = 0.028) and HS-VAS (P MCT in GHS/QoL. Overall, VEN may positively impact HRQoL in patients with AML ineligible for intensive chemotherapy, leading to longer preservation of functioning and overall health status.

Published
2022

8. Selinexor, bortezomib, and dexamethasone versus bortezomib and dexamethasone in previously treated multiple myeloma: Outcomes by cytogenetic risk.

Author

Richard, Shambavi, Chari, Ajai, Delimpasi, Sosana, Simonova, Maryana, Spicka, Ivan, Pour, Ludek, Kriachok, Iryna, Dimopoulos, Meletios, Pylypenko, Halyna, Auner, Holger, Leleu, Xavier, Usenko, Ganna, Hajek, Roman, Benjamin, Reuben, Dolai, Tuphan, Sinha, Dinesh, Venner, Christopher, Garg, Mamta, Stevens, Don, Quach, Hang, Jagannath, Sundar, Moreau, Phillipe, Levy, Moshe, Badros, Ashraf, Anderson, Larry, Bahlis, Nizar, Facon, Thierry, Mateos, Maria, Cavo, Michele, Chang, Hua, Landesman, Yosef, Chai, Yi, Arazy, Melina, Shah, Jatin, Shacham, Sharon, Kauffman, Michael, Grosicki, Sebastian, and Richardson, Paul

Subjects
Adult, Aged, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Bortezomib, Cytogenetic Analysis, Dexamethasone, Female, Humans, Hydrazines, Male, Middle Aged, Multiple Myeloma, Progression-Free Survival, Treatment Outcome, Triazoles, Young Adult
Abstract

In the phase 3 BOSTON study, patients with multiple myeloma (MM) after 1-3 prior regimens were randomized to once-weekly selinexor (an oral inhibitor of exportin 1 [XPO1]) plus bortezomib-dexamethasone (XVd) or twice-weekly bortezomib-dexamethasone (Vd). Compared with Vd, XVd was associated with significant improvements in median progression-free survival (PFS), overall response rate (ORR), and lower rates of peripheral neuropathy, with trends in overall survival (OS) favoring XVd. In BOSTON, 141 (35.1%) patients had MM with high-risk (presence of del[17p], t[4;14], t[14;16], or ≥4 copies of amp1q21) cytogenetics (XVd, n = 70; Vd, n = 71), and 261 (64.9%) exhibited standard-risk cytogenetics (XVd, n = 125; Vd, n = 136). Among patients with high-risk MM, median PFS was 12.91 months for XVd and 8.61 months for Vd (HR, 0.73 [95% CI, (0.4673, 1.1406)], p = 0.082), and ORRs were 78.6% and 57.7%, respectively (OR 2.68; p = 0.004). In the standard-risk subgroup, median PFS was 16.62 months for XVd and 9.46 months for Vd (HR 0.61; p = 0.004), and ORRs were 75.2% and 64.7%, respectively (OR 1.65; p = 0.033). The safety profiles of XVd and Vd in both subgroups were consistent with the overall population. These data suggest that selinexor can confer benefits to patients with MM regardless of cytogenetic risk. ClinicalTrials.gov identifier: NCT03110562.

Published
2021

10. Safety and efficacy of tafasitamab with or without lenalidomide added to first-line R-CHOP for DLBCL: the phase 1b First-MIND study

Author

Belada, David, Kopeckova, Katerina, Bergua Burgues, Juan Miguel, Stevens, Don, André, Marc, Persona, Ernesto Perez, Pichler, Petra, Staber, Philipp B., Trneny, Marek, Duell, Johannes, Waldron-Lynch, Maeve, Wagner, Steve, Mukhopadhyay, Amitava, Dirnberger-Hertweck, Maren, Burke, John M., and Nowakowski, Grzegorz S.

Published
2023
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11. Addition of elotuzumab to lenalidomide and dexamethasone for patients with newly diagnosed, transplantation ineligible multiple myeloma (ELOQUENT-1): an open-label, multicentre, randomised, phase 3 trial

Author

Dimopoulos, Meletios A, Richardson, Paul G, Bahlis, Nizar J, Grosicki, Sebastian, Cavo, Michele, Beksaç, Meral, Legieć, Wojciech, Liberati, Anna M, Goldschmidt, Hartmut, Belch, Andrew, Magen, Hila, Larocca, Alessandra, Laubach, Jacob P, Petrucci, Maria T, Reece, Donna, White, Darrell, Mateos, María-Victoria, Špička, Ivan, Lazaroiu, Mihaela, Berdeja, Jesús, Kaufman, Jonathan L, Jou, Ying-Ming, Ganetsky, Alex, Popa McKiver, Mihaela, Lonial, Sagar, Weisel, Katja, Sandhu, Irwindeep, Podhorecka, Monika, Palumbo, Antonio, Shacham-Abulafia, Adi, Vaxman, Iuliana, Shpilberg, Ofer, Besemer, Britta, Martelli, Maurizio, Foà, Roberto, De Fabritiis, Paolo, Caravita di Toritto, Tommaso, Gheorghita, Emanuil, Oriol, Albert, Rowlings, Philip, Emanuele, Angelucci, Carella, Angelo M, Offidani, Massimo, Bladé, Joan, Casado, Luis F, Oakervee, Heather, Panelli, Victoria, Meza, Luis, Kühr, Thomas, Granell, Miguel, Benson, Don, Nair, Rajesh, Holden, Viran, Reeves, James, Jr., Eek, Richard W, Walker, Patricia A, Catalano, John, Rosta, András, Lech-Marańda, Ewa, Samaras, Christy, Reiman, Anthony, Weaver, Robert, Acs, Peter, Grigg, Andrew, De Prijck, Bernard, Louzada, Martha, Minuk, Leonard, Sebag, Michael, Klausmann, Martine, Welslau, Manfred, Hellmann, Andrzej, Danaila, Catalin, Becker, Pamela, Bensinger, William, Porterfield, Bruce, Modiano, Manuel, Schultz, Stephen M, Manges, Robert, Lee, Huey-Shin Cindy, Gray, James X, Wright, Matthew P, Vekemans, Marie-Christine, Hamed, Aryan, Gasztonyi, Zoltán, Mikala, Gábor, Masszi, Tamás, Gamberi, Barbara, Kuliczkowski, Kazimierz, Usnarska-Zubkiewicz, Lidia, Bengoechea, Enrique, Gutiérrez, María AE, García, Miguel TH, San-Miguel, Jesús, Driessen, Christoph, Behl, Rajesh, Brenner, Warren, Gray, Carl, Hansen, Vincent, Moezi, Mehdi, Cortes, Hector V, Yen, Charles, Gressot, Laurent, Horvath, Noemi, D'Rozario, James M, Latimer, Maya, Kyrtsonis, Maria-Christine, Chubar, Evgeni, Mittelman, Moshe, Baldini, Luca, Tosi, Patrizia, Vacca, Angelo, Jędrzejczak, Wiesław W, Robak, Tadeusz, Lahuerta, Juan J, Carney, Jennifer, Chen, Franklin, Hirsch, Robert, Ruiz, Marco, Alencar, Alvaro, Jagasia, Madan, Kasbari, Samer, Kuriakose, Philip, Mahmood, Aftab, Chaudhry, Madhu, Cohen, Gary, Noga, Stephen, Roa, Sch, Jakubowiak, Andrzej, Rosenbaum, Cara, Delforge, Michel, Delrieu, Vanessa, Doyen, Chantal, Dries, Deeren, Demuynck, Hilde, Schots, Rik, Maisnar, Vladimir, Blau, Igor W, Dürk, Heinz A, Kerkhoff, Andrea, Kropff, Martin, Munder, Markus, Röllig, Christoph, Scheid, Christof, Symeonidis, Argiris S, Illés, Árpád, Coyne, Mark, O'Gorman, Peter, Hayden, Patrick, O'Dwyer, Michael, Ben-Yehuda, Dina, Braester, Andrei, Nemets, Anatoly, Lugassy, Gilles, Cohen, Yossi, Rahimi-Levene, Naomi, Bosi, Alberto, Pezzatti, Sara, Rossini, Fausto, Pogliani, Enrico M, Pinto, Antonello, Komarnicki, Mieczysław, Borsaru, Gabriela, Stoia, Razvan, Afanasyev, Boris, Goñi, María A, Carboneras, Ana V, Ali, Sarah, Rubenstein, S. Eric, Caputto, Salvador, Cosgriff, Thomas, Fanning, Suzanne, Khojasteh, Ali, Liman, Andrew, Malcolm, Albert, Vrindavanam, Nandagopal, Patel, Ravindranath, Belani, Rajesh, Shieh, Marie, Stockerl-Goldstein, Keith, Strnad, Charles, Stuart, Robert, Chhabra, Saurabh, Costa, Luciano, Jhangiani, Haresh, Augustson, Bradley, Filshie, Robin, Johnston, Amanda, Hertzberg, Mark S, Mineur, Philippe, Fox, Susan, Kotb, Rami, Dao, Vi, LeBlanc, Richard, Gregora, Evzen, Brioli, Annamaria, Mügge, Lars-Olof, Hänel, Mathias, Langer, Christian, Kapsali, Eleni, Briasoulis, Evangelos, Kyriakou, Despoina, Hardan, Izhar, Horowitz, Netanel A, Clotilde, Cangialosi, Fabbiano, Francesco, Castagnari, Barbara, Ciceri, Fabio, Musuraca, Gerardo, Deptała, Andrzej, Kłoczko, Janusz, Balea, Marius, Vladareanu, Ana-Maria, Rossiev, Victor, Alegre, Adrián, Encinas, Cristina, Gayoso, Jorge, Pabst, Thomas, Rabin, Neil, Arledge, Sherri, Cabanillas, Fernando, Catlett, Joseph, Chidiac, Tarek, Clarkson, David, Dhodapkar, Madhav, Geils, George, Jr., Khan, Cyrus MA, Sahovic, Entezam, Khasawneh, Mohamad, Sehgal, Rajesh, Ballester, Oscar, Levy, Moshe, Fay, Joseph, Liem, Kiem, Lunning, Matthew, Vose, Julie, Faber, Edward, Jr., MacFarlane, Donald, Hohl, Raymond, Mahmood, Tariq, Bhaskar, Birbal, Mims, Martha, Oliff, Ira, Paner, Agne, Maciejewski, John, Padmanabhan, Arvinda, Richard, Robert, Sanyal, Amit, Schiller, Gary, Staszewski, Harry, Stevens, Don, Vaughn, Christopher, and Windsor, Kevin

Published
2022
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14. Melflufen or pomalidomide plus dexamethasone for patients with multiple myeloma refractory to lenalidomide (OCEAN): a randomised, head-to-head, open-label, phase 3 study

Author

Schjesvold, Fredrik, Delimpasi, Sosana, Robak, Pawel, Coriu, Daniel, Nikolayeva, Anna, Tomczak, Waldemar, Pour, Ludek, Spicka, Ivan, Dimopoulos, Meletios-Athanasios, Masszi, Tamas, Doronin, Vadim, Minarik, Jiri, Salogub, Galina, Alekseeva, Yulia, Maisnar, Vladimir, Mikala, Gabor, Rosinol, Laura, Konstantinova, Tatiana, Lazzaro, Antonio, Liberati, Anna Marina, Symeonidis, Anargyros, Gatt, Moshe, Illes, Arpad, Abdulhaq, Haifaa, Dungarwalla, Moez, Grosicki, Sebastian, Hajek, Roman, Leleu, Xavier, Myasnikov, Alexander, Richardson, Paul G., Avivi, Irit, Deeren, Dries, Gironella, Mercedes, Hernandez-Garcia, Miguel Teodoro, Martinez Lopez, Joaquin, Newinger-Porte, Muriel, Ribas, Paz, Samoilova, Olga, Voog, Eric, Arnao-Herraiz, Mario, Carrillo-Cruz, Estrella, Corradini, Paolo, Dodlapati, Jyothi, Granell Gorrochategui, Miquel, Huang, Shang-Yi, Jenner, Matthew, Karlin, Lionel, Kim, Jin Seok, Kopacz, Agnieszka, Medvedeva, Nadezhda, Min, Chang-Ki, Mina, Roberto, Palk, Katrin, Shin, Ho-Jin, Sohn, Sang Kyun, Sonneveld, Pieter, Tache, Jason, Anagnostopoulos, Achilles, Arguiñano, Jose-Maria, Cavo, Michele, Filicko, Joanne, Garnes, Margaret, Halka, Janusz, Herzog-Tzarfati, Kathrin, Ipatova, Natalia, Kim, Kihyun, Krauth, Maria-Theresa, Kryuchkova, Irina, Lazaroiu, Mihaela Cornelia, Luppi, Mario, Proydakov, Andrei, Rambaldi, Alessandro, Rudzianskiene, Milda, Yeh, Su-Peng, Alcalá-Peña, Maria Magdalena, Alegre Amor, Adrian, Alizadeh, Hussain, Bendandi, Maurizio, Brearton, Gillian, Brown, Randall, Cavet, Jim, Dally, Najib, Egyed, Miklos, Hernández-Rivas, José Ángel, Kaare, Ain, Karsenti, Jean-Michel, Kloczko, Janusz, Kreisle, William, Lee, Je-Jung, Legiec, Wojciech, Machherndl-Spandl, Sigrid, Manda, Sudhir, Mateos, Maria-Victoria, Moiseev, Ivan, Moreb, Jan, Nagy, Zsolt, Nair, Santosh, Oriol-Rocafiguera, Albert, Osswald, Michael, Otero-Rodriguez, Paula, Peceliunas, Valdas, Plesner, Torben, Rey, Philippe, Rossi, Giuseppe, Stevens, Don, Suriu, Celia, Tarella, Corrado, Verlinden, Anke, Zannetti, Alain, Schjesvold, Fredrik H, Pour, Luděk, Špička, Ivan, Mikala, Gábor, Rosiñol, Laura, Symeonidis, Argiris, Moody, Victoria, Thuresson, Marcus, Byrne, Catriona, Harmenberg, Johan, Bakker, Nicolaas A, Hájek, Roman, and Richardson, Paul G

Published
2022
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16. Single-agent ibrutinib versus chemoimmunotherapy regimens for treatment-naïve patients with chronic lymphocytic leukemia: A cross-trial comparison of phase 3 studies.

Author

Robak, Tadeusz, Burger, Jan A, Tedeschi, Alessandra, Barr, Paul M, Owen, Carolyn, Bairey, Osnat, Hillmen, Peter, Simpson, David, Grosicki, Sebastian, Devereux, Stephen, McCarthy, Helen, Coutre, Steven E, Quach, Hang, Gaidano, Gianluca, Maslyak, Zvenyslava, Stevens, Don A, Moreno, Carol, Gill, Devinder S, Flinn, Ian W, Gribben, John G, Mokatrin, Ahmad, Cheng, Mei, Styles, Lori, James, Danelle F, Kipps, Thomas J, and Ghia, Paolo

Subjects
Humans, Pyrazoles, Pyrimidines, Antineoplastic Combined Chemotherapy Protocols, Treatment Outcome, Immunotherapy, Survival Analysis, Retrospective Studies, Aged, Middle Aged, Female, Male, Clinical Trials as Topic, Leukemia, Lymphocytic, Chronic, B-Cell, Cancer, Clinical Trials and Supportive Activities, Lymphoma, Rare Diseases, Clinical Research, Hematology, 6.1 Pharmaceuticals, Immunology, Cardiorespiratory Medicine and Haematology
Abstract

Chemoimmunotherapy (CIT) and targeted therapy with single-agent ibrutinib are both recommended first-line treatments for chronic lymphocytic leukemia (CLL), although their outcomes have not been directly compared. Using ibrutinib data from the RESONATE-2 (PCYC-1115/1116) study conducted in patients ≥65 years without del(17p), we performed a cross-trial comparison with CIT data from published phase 3 studies in first-line treatment of CLL. Progression-free survival (PFS), overall survival (OS), and safety data for ibrutinib (median follow-up 35.7 months) were evaluated alongside available CIT data. CIT regimens included: fludarabine + cyclophosphamide + rituximab (CLL8, CLL10), bendamustine + rituximab (CLL10), obinutuzumab + chlorambucil and rituximab + chlorambucil (CLL11), and ofatumumab + chlorambucil (COMPLEMENT-1). Median age across studies was 61-74 years, with older populations receiving ibrutinib, obinutuzumab + chlorambucil, or rituximab + chlorambucil. Median follow-up varied across studies/regimens (range 14.5-37.4 months). Among all patients, PFS appeared longer with ibrutinib relative to CIT and OS appeared comparable. Relative to CIT studies that similarly excluded patients with del(17p) (CLL10) or enrolled older/less-fit patients (CLL11), PFS appeared favorable for ibrutinib in high-risk subgroups, including advanced disease, bulky lymph nodes, unmutated IGHV status, and presence of del(11q). Grade ≥ 3 infections ranged from 9% (ofatumumab + chlorambucil) to 40% (fludarabine + cyclophosphamide + rituximab), and was 25% with ibrutinib. Grade ≥ 3 neutropenia was 12% for ibrutinib and 26%-84% for CIT. Although definitive conclusions cannot be made due to inherent limitations of cross-trial comparisons, this report suggests that ibrutinib has a favorable benefit/risk profile and may potentially eliminate the need for chemotherapy in some patients. Randomized, comparative studies are needed to support these findings.

Published
2018

17. Durable complete response and overall survival in patients with heavily pretreated, poor-prognosis non-Hodgkin lymphoma to immunoactivating AVM0703 with few and mild drug-related adverse effects.

Author

Budde, Lihua Elizabeth, primary, Deisher, Theresa, additional, Stevens, Don A., additional, Schiller, Gary J., additional, Tarantolo, Stefano R., additional, Ramaekers, Ryan C., additional, Jarzyna, Peter, additional, Sawas, Spencer, additional, and Mittal, Sandeep, additional

Published
2024
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24. Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, phase 3 trial

Author

Grosicki, Sebastian, Simonova, Maryana, Spicka, Ivan, Pour, Ludek, Kriachok, Iryrna, Gavriatopoulou, Maria, Pylypenko, Halyna, Auner, Holger W, Leleu, Xavier, Doronin, Vadim, Usenko, Ganna, Bahlis, Nizar J, Hajek, Roman, Benjamin, Reuben, Dolai, Tuphan K, Sinha, Dinesh K, Venner, Christopher P, Garg, Mamta, Gironella, Mercedes, Jurczyszyn, Artur, Robak, Pawel, Galli, Monica, Wallington-Beddoe, Craig, Radinoff, Atanas, Salogub, Galina, Stevens, Don A, Basu, Supratik, Liberati, Anna M, Quach, Hang, Goranova-Marinova, Vesselina S, Bila, Jelena, Katodritou, Eirini, Oliynyk, Hanna, Korenkova, Sybiryna, Kumar, Jeevan, Jagannath, Sundar, Moreau, Phillipe, Levy, Moshe, White, Darrell, Gatt, Moshe E, Facon, Thierry, Mateos, Maria V, Cavo, Michele, Reece, Donna, Anderson, Larry D, Jr, Saint-Martin, Jean-Richard, Jeha, Jacqueline, Joshi, Anita A, Chai, Yi, Li, Lingling, Peddagali, Vishnuvardhan, Arazy, Melina, Shah, Jatin, Shacham, Sharon, Kauffman, Michael G, Dimopoulos, Meletios A, Richardson, Paul G, and Delimpasi, Sosana

Published
2020
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25. Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: a phase 3 randomized placebo-controlled trial

Author

Wei, Andrew H., Montesinos, Pau, Ivanov, Vladimir, DiNardo, Courtney D., Novak, Jan, Laribi, Kamel, Kim, Inho, Stevens, Don A., Fiedler, Walter, Pagoni, Maria, Samoilova, Olga, Hu, Yu, Anagnostopoulos, Achilles, Bergeron, Julie, Hou, Jing-Zhou, Murthy, Vidhya, Yamauchi, Takahiro, McDonald, Andrew, Chyla, Brenda, Gopalakrishnan, Sathej, Jiang, Qi, Mendes, Wellington, Hayslip, John, and Panayiotidis, Panayiotis

Published
2020
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26. Selinexor-Based Triplet Regimens in Patients With Multiple Myeloma Previously Treated With Anti-CD38 Monoclonal Antibodies

Author

Schiller, Gary J., Lipe, Brea C., Bahlis, Nizar J., Tuchman, Sascha A., Bensinger, William I., Sutherland, Heather J., Lentzsch, Suzanne, Baljevic, Muhamed, White, Darrell, Kotb, Rami, Chen, Christine I., Rossi, Adriana, Biran, Noa, LeBlanc, Richard, Grosicki, Sebastian, Martelli, Maurizio, Gunsilius, Eberhard, Špička, Ivan, Stevens, Don Ambrose, Facon, Thierry, Mesa, Mercedes Gironella, Zhang, Chris, Van Domelen, Dane R., Bentur, Ohad S., and Gasparetto, Cristina

Published
2023
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27. Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia

Author

Burger, Jan A, Tedeschi, Alessandra, Barr, Paul M, Robak, Tadeusz, Owen, Carolyn, Ghia, Paolo, Bairey, Osnat, Hillmen, Peter, Bartlett, Nancy L, Li, Jianyong, Simpson, David, Grosicki, Sebastian, Devereux, Stephen, McCarthy, Helen, Coutre, Steven, Quach, Hang, Gaidano, Gianluca, Maslyak, Zvenyslava, Stevens, Don A, Janssens, Ann, Offner, Fritz, Mayer, Jiří, O'Dwyer, Michael, Hellmann, Andrzej, Schuh, Anna, Siddiqi, Tanya, Polliack, Aaron, Tam, Constantine S, Suri, Deepali, Cheng, Mei, Clow, Fong, Styles, Lori, James, Danelle F, and Kipps, Thomas J

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Clinical Research, Lymphoma, Hematology, Orphan Drug, Cancer, Rare Diseases, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adenine, Aged, Antineoplastic Agents, Chlorambucil, Diarrhea, Disease-Free Survival, Fatigue, Female, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Male, Neutropenia, Piperidines, Pyrazoles, Pyrimidines, Survival Analysis, RESONATE-2 Investigators, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundChronic lymphocytic leukemia (CLL) primarily affects older persons who often have coexisting conditions in addition to disease-related immunosuppression and myelosuppression. We conducted an international, open-label, randomized phase 3 trial to compare two oral agents, ibrutinib and chlorambucil, in previously untreated older patients with CLL or small lymphocytic lymphoma.MethodsWe randomly assigned 269 previously untreated patients who were 65 years of age or older and had CLL or small lymphocytic lymphoma to receive ibrutinib or chlorambucil. The primary end point was progression-free survival as assessed by an independent review committee.ResultsThe median age of the patients was 73 years. During a median follow-up period of 18.4 months, ibrutinib resulted in significantly longer progression-free survival than did chlorambucil (median, not reached vs. 18.9 months), with a risk of progression or death that was 84% lower with ibrutinib than that with chlorambucil (hazard ratio, 0.16; P

Published
2015

28. Effect of prior treatments on selinexor, bortezomib, and dexamethasone in previously treated multiple myeloma

Author

Mateos, Maria V., Gavriatopoulou, Maria, Facon, Thierry, Auner, Holger W., Leleu, Xavier, Hájek, Roman, Dimopoulos, Meletios A., Delimpasi, Sosana, Simonova, Maryana, Špička, Ivan, Pour, Ludĕk, Kriachok, Iryna, Pylypenko, Halyna, Doronin, Vadim, Usenko, Ganna, Benjamin, Reuben, Dolai, Tuphan K., Sinha, Dinesh K., Venner, Christopher P., Garg, Mamta, Stevens, Don A., Quach, Hang, Jagannath, Sundar, Moreau, Philippe, Levy, Moshe, Badros, Ashraf Z., Anderson, Jr., Larry D., Bahlis, Nizar J., Cavo, Michele, Chai, Yi, Jeha, Jacqueline, Arazy, Melina, Shah, Jatin, Shacham, Sharon, Kauffman, Michael G., Richardson, Paul G., and Grosicki, Sebastian

Published
2021
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29. Author Correction: 6-month follow-up of VIALE-C demonstrates improved and durable efficacy in patients with untreated AML ineligible for intensive chemotherapy

Author

Wei, Andrew H., Panayiotidis, Panayiotis, Montesinos, Pau, Laribi, Kamel, Ivanov, Vladimir, Kim, Inho, Novak, Jan, Stevens, Don A., Fiedler, Walter, Pagoni, Maria, Bergeron, Julie, Ting, Stephen B., Hou, Jing-Zhou, Anagnostopoulos, Achilles, McDonald, Andrew, Murthy, Vidhya, Yamauchi, Takahiro, Wang, Jianxiang, Chyla, Brenda, Sun, Yan, Jiang, Qi, Mendes, Wellington, Hayslip, John, and DiNardo, Courtney D.

Published
2021
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30. 6-month follow-up of VIALE-C demonstrates improved and durable efficacy in patients with untreated AML ineligible for intensive chemotherapy

Author

Wei, Andrew H., Panayiotidis, Panayiotis, Montesinos, Pau, Laribi, Kamel, Ivanov, Vladimir, Kim, Inho, Novak, Jan, Stevens, Don A., Fiedler, Walter, Pagoni, Maria, Bergeron, Julie, Ting, Stephen B., Hou, Jing-Zhou, Anagnostopoulos, Achilles, McDonald, Andrew, Murthy, Vidhya, Yamauchi, Takahiro, Wang, Jianxiang, Chyla, Brenda, Sun, Yan, Jiang, Qi, Mendes, Wellington, Hayslip, John, and DiNardo, Courtney D.

Published
2021
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31. Pembrolizumab plus lenalidomide and dexamethasone for patients with treatment-naive multiple myeloma (KEYNOTE-185): a randomised, open-label, phase 3 trial

Author

Lim, Andrew, Grigoriadis, George, Walker, Trish, Nicol, Andrew, LeBlanc, Richard, Reece, Donna, Elemary, Mohamed, Boudreault Pedneault, Jean Samuel, Karlin, Lionel, Facon, Thierry, Attal, Michel, Weisel, Katja, Engelhardt, Monika, Mackensen, Andreas, Quinn, John, Avivi, Irit, Cohen, Amos, Magen-Nativ, Hila, Benyamini, Noam, Cavo, Michele, Larocca, Alessandra, Takezako, Naoki, Suzuki, Kenshi, Kosugi, Hiroshi, Matsumoto, Morio, Iida, Shinsuke, Ishikawa, Takayuki, Kondo, Yukio, Sunami, Kazutaka, Ando, Kiyoshi, Teshima, Takanori, Chou, Takaaki, Iwasaki, Hiromi, Miki, Hirokazu, Matsumura, Itaru, Onishi, Yasushi, Izutsu, Koji, Kizaki, Masahiro, George, Anupkumar, Blacklock, Hillary, Simpson, David, Schjesvold, Fredrik, Waage, Anders, Samoilova, Olga, Nikitin, Evgeniy, Chagorova, Tatiana, McDonald, Andrew, Patel, Moosa, Oriol Rocafiguera, Albert, San Miguel Izquierdo, Jesus, Mateos, Maria, Streetly, Matthew, Forsyth, Peter, Jackson, Graham, Jenkins, Stephen, Rifkin, Robert, Yimer, Habte, McCroskey, Robert, Martincic, Danko, Tarantolo, Stefano, Larson, Sarah, Faroun, Yacoub, Vaughn, Jennifer, Baz, Rachid, Saylors, Gene, Neppalli, Amarendra, Raptis, Anastasios, Fung, Henry, Janosky, Maxwell, Stevens, Don, Coleman, Morton, Costa, Dennis, Cross, Scott, Fanning, Suzanne, Berges, Daniel Farray, Harris, Thomas, Zackon, Ira, Atanackovic, Djordje, Lee, Kelvin, Oliff, Ira, Lee, Wes, Bensinger, William, Lutzky, Jose, Baron, Ari, Hayek, Fadi, Kirschner, Eli, Bharany, Neeraj, Overton, Lindsay, Mannem, Siva, Harroff, Allyson, Jain, Sharad, Roque, Tammy, McIntyre, Kristi, Yasencha, Christopher K, Houck, William, Usmani, Saad Zafar, Oriol, Albert, Rifkin, Robert M, Yimer, Habte Aragaw, McCroskey, Robert Donald, Lim, Andrew Boon Ming, Jagannath, Sundar, Lonial, Sagar, Ghori, Razi Uddin, Farooqui, Mohammed Z H, Marinello, Patricia, and San-Miguel, Jesus

Published
2019
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33. Reasons to Be Skeptical about Sentience and Pain in Fishes and Aquatic Invertebrates

Author

Diggles, Benjamin K., primary, Arlinghaus, Robert, additional, Browman, Howard I., additional, Cooke, Steven J., additional, Cooper, Robin L., additional, Cowx, Ian G., additional, Derby, Charles D., additional, Derbyshire, Stuart W., additional, Hart, Paul JB, additional, Jones, Brian, additional, Kasumyan, Alexander O., additional, Key, Brian, additional, Pepperell, Julian G., additional, Rogers, D Christopher, additional, Rose, James D., additional, Schwab, Alex, additional, Skiftesvik, Anne B., additional, Stevens, Don, additional, Shields, Jeffrey D., additional, and Watson, Craig, additional

Published
2023
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35. CLL-106 First Prospective Data on Minimal Residual Disease Outcomes After Fixed-Duration Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for First-Line Treatment of CLL in Older Adult or Unfit Patients: The GLOW Study

Author

Munir, Talha, Moreno, Carol, Owen, Carolyn, Follows, George, Benjamini, Ohad, Janssens, Ann, Levin, Mark-David, Osterborg, Anders, Robak, Tadeusz, Simkovic, Martin, Stevens, Don, Voloshin, Sergey, Vorobyev, Vladimir, Yagci, Munci, Ysebaert, Loic, Qi, Qianya, Steele, Andrew, Schuier, Natasha, Baeten, Kurt, Caces, Donne Bennett, Niemann, Carsten, and Kater, Arnon

Published
2022
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36. MM-364 Elranatamab, a B-Cell Maturation Antigen (BCMA)-CD3 Bispecific Antibody, for Patients With Relapsed/Refractory Multiple Myeloma (RRMM): Extended Follow-Up and Biweekly Administration From the MagnetisMM-3 Study

Author

Mohty, Mohamad, primary, Tomasson, Michael H., additional, Arnulf, Bertrand, additional, Bahlis, Nizar J., additional, Prince, H. Miles, additional, Niesvizky, Ruben, additional, Rodrίguez-Otero, Paula, additional, Martinez-Lopez, Joaquin, additional, Koehne, Guenther, additional, Jethava, Yogesh, additional, Gabayan, Afshin E., additional, Stevens, Don A., additional, Nooka, Ajay K., additional, Raje, Noopur, additional, Iida, Shinsuke, additional, Leip, Eric, additional, Conte, Umberto, additional, Czibere, Akos, additional, Viqueira, Andrea, additional, and Lesokhin, Alexander M., additional

Published
2023
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37. POSTER: MM-364 Elranatamab, a B-Cell Maturation Antigen (BCMA)-CD3 Bispecific Antibody, for Patients With Relapsed/Refractory Multiple Myeloma (RRMM): Extended Follow-Up and Biweekly Administration From the MagnetisMM-3 Study

Author

Mohty, Mohamad, primary, Tomasson, Michael H., additional, Arnulf, Bertrand, additional, Bahlis, Nizar J., additional, Prince, H. Miles, additional, Niesvizky, Ruben, additional, Rodrίguez-Otero, Paula, additional, Martinez-Lopez, Joaquin, additional, Koehne, Guenther, additional, Jethava, Yogesh, additional, Gabayan, Afshin E., additional, Stevens, Don A., additional, Nooka, Ajay K., additional, Raje, Noopur, additional, Iida, Shinsuke, additional, Leip, Eric, additional, Conte, Umberto, additional, Czibere, Akos, additional, Viqueira, Andrea, additional, and Lesokhin, Alexander M., additional

Published
2023
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38. S101: OMISSION OF RADIOTHERAPY IN PRIMARY MEDIASTINAL B-CELL LYMPHOMA PATIENTS FOLLOWING COMPLETE METABOLIC RESPONSE TO STANDARD IMMUNOCHEMOTHERAPY: RESULTS OF THE IELSG37 RANDOMISED TRIAL (NCT01599559)

Author

Martelli, Maurizio, primary, Ceriani, Luca, additional, Zucca, Emanuele, additional, Kryachok, Irina, additional, Ciccone, Giovannino, additional, Ricardi, Umberto, additional, Botto, Barbara, additional, Balzarotti, Monica, additional, Tucci, Alessandra, additional, Veronica Usai, Sara, additional, Pennese, Elsa, additional, Arcaini, Luca, additional, Dabrowska-Iwanicka, Anna, additional, José María Ferreri, Andrés, additional, Marli, Francesco, additional, Zhao, Weili, additional, Hodgson, David, additional, Ionescu, Codruta, additional, Rigacci, Luigi, additional, Cellini, Claudia, additional, Stelitano, Caterina, additional, Zaja, Francesco, additional, Guarini, Attilio, additional, Spina, Michele, additional, Fossa, Alexander, additional, Cwynarski, Kate, additional, Mikhaeel, N. George, additional, Jerkeman, Mats, additional, Janíková, Andrea, additional, Huettmann, Andreas, additional, Silva, Maria Gomes Da, additional, Stevens, Don, additional, Petrucci, Luigi, additional, Barrington, Sally, additional, Malkowski, Bogdan, additional, Metser, Ur, additional, Versari, Annibale, additional, Bagni, Oreste, additional, Chauvie, Stephane, additional, Cozens, Kelly, additional, Perticone, Sonia, additional, Ielmini, Nicoletta, additional, Cavalli, Franco, additional, Gosodarowicz, Mary, additional, Johnson, Peter W., additional, and Davies, Andrew, additional

Published
2023
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39. P1125: DURABLES RESPONSES ACHIEVED WITH ANTI-CD19 ALLOGENEIC CAR T ALLO-501/501A IN PHASE 1 TRIALS OF AUTOLOGOUS CAR T-NAÏVE PATIENTS WITH RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA (R/R LBCL)

Author

Munoz, Javier, primary, Locke, Frederick, additional, Lekakis, Lazaros, additional, Eradat, Herbert, additional, Tees, Michael, additional, de Vos, Sven, additional, Nath, Rajneesh, additional, Stevens, Don, additional, Malik, Shahbaz, additional, Popplewell, Leslie, additional, Hamadani, Mehdi, additional, Oluwole, Olalekan, additional, Perales, Miguel-Angel, additional, Miklos, David, additional, Fisher, Paul, additional, Goyal, Lovely, additional, Navale, Lynn, additional, Kaufman, Gregory, additional, Kai, Kazuharu, additional, Balakumaran, Arun, additional, and Neelapu, Sattva, additional

Published
2023
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40. P1094: SAFETY AND EFFICACY OF ACALABRUTINIB, BENDAMUSTINE, AND RITUXIMAB IN PATIENTS WITH TREATMENT-NAIVE OR RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA: PHASE IB TRIAL

Author

Phillips, Tycel, primary, Wang, Michael, additional, Robak, Tadeusz, additional, Gallinson, David, additional, Stevens, Don, additional, Patel, Krish, additional, Ramadan, Safaa, additional, Wun, Chuan-Chaun, additional, Jurczak, Wojciech, additional, and Smith, Stephen D., additional

Published
2023
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41. P644: IBRUTINIB DOSE MODIFICATIONS FOR MANAGEMENT OF CARDIAC ADVERSE EVENTS IN PATIENTS WITH B-CELL MALIGNANCIES: POOLED ANALYSIS OF 10 CLINICAL TRIALS

Author

Stephens, Deborah, primary, R. Brown, Jennifer, additional, MA, Shuo, additional, Wang, Michael, additional, Moreno, Carol, additional, Robak, Tadeusz, additional, Stevens, Don, additional, Lee, Shane, additional, Saifan, Chadi, additional, Hsu, Emily, additional, Patel, Sima, additional, and Burger, Jan, additional

Published
2023
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42. S224: HIGH COMPLETE RESPONSE RATE WITH TNB-486, A NOVEL CD19XCD3 T-CELL ENGAGER, IN RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA: INTERIM RESULTS FROM AN ONGOING PHASE 1 STUDY

Author

Jacobs, Ryan, primary, Nair, Ranjit, additional, Cho, Seok-Goo, additional, Devata, Sumana, additional, Gaballa, Sameh, additional, Yoon, Dok Hyun, additional, Stevens, Don, additional, Kim, Jin Seok, additional, Shah, Nirav N, additional, Brennan, Denise Marie, additional, Law, Jason, additional, Lesley, Robin, additional, Chen, Rob, additional, Forcina, Alessandra, additional, Buelow, Ben, additional, and Hou, Jing-Zhou, additional

Published
2023
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43. Impact of Minimal Residual Disease on Progression-Free Survival Outcomes After Fixed-Duration Ibrutinib-Venetoclax Versus Chlorambucil-Obinutuzumab in the GLOW Study

Author

Munir, Talha, primary, Moreno, Carol, additional, Owen, Carolyn, additional, Follows, George, additional, Benjamini, Ohad, additional, Janssens, Ann, additional, Levin, Mark-David, additional, Osterborg, Anders, additional, Robak, Tadeusz, additional, Simkovic, Martin, additional, Stevens, Don, additional, Voloshin, Sergey, additional, Vorobyev, Vladimir, additional, Yagci, Munci, additional, Ysebaert, Loic, additional, Qi, Keqin, additional, Qi, Qianya, additional, Parisi, Lori, additional, Srinivasan, Srimathi, additional, Schuier, Natasha, additional, Baeten, Kurt, additional, Howes, Angela, additional, Caces, Donne Bennett, additional, Niemann, Carsten U., additional, and Kater, Arnon P., additional

Published
2023
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47. Reasons to Be Skeptical about Sentience and Pain in Fishes and Aquatic Invertebrates.

Author

Diggles, Benjamin K., Arlinghaus, Robert, Browman, Howard I., Cooke, Steven J., Cooper, Robin L., Cowx, Ian G., Derby, Charles D., Derbyshire, Stuart W., Hart, Paul JB, Jones, Brian, Kasumyan, Alexander O., Key, Brian, Pepperell, Julian G., Rogers, D Christopher, Rose, James D., Schwab, Alex, Skiftesvik, Anne B., Stevens, Don, Shields, Jeffrey D., and Watson, Craig

Subjects
AQUATIC invertebrates, ANIMAL welfare, AQUATIC animals, AQUATIC organisms, FOOD security
Abstract

The welfare of fishes and aquatic invertebrates is important, and several jurisdictions have included these taxa under welfare regulation in recent years. Regulation of welfare requires use of scientifically validated welfare criteria. This is why applying Mertonian skepticism toward claims for sentience and pain in fishes and aquatic invertebrates is scientifically sound and prudent, particularly when those claims are used to justify legislation regulating the welfare of these taxa. Enacting welfare legislation for these taxa without strong scientific evidence is a societal and political choice that risks creating scientific and interpretational problems as well as major policy challenges, including the potential to generate significant unintended consequences. In contrast, a more rigorous science-based approach to the welfare of aquatic organisms that is based on verified, validated and measurable endpoints is more likely to result in "win-win" scenarios that minimize the risk of unintended negative impacts for all stakeholders, including fish and aquatic invertebrates. The authors identify as supporters of animal welfare, and emphasize that this issue is not about choosing between welfare and no welfare for fish and aquatic invertebrates, but rather to ensure that important decisions about their welfare are based on scientifically robust evidence. These ten reasons are delivered in the spirit of organized skepticism to orient legislators, decision makers and the scientific community, and alert them to the need to maintain a high scientific evidential bar for any operational welfare indicators used for aquatic animals, particularly those mandated by legislation. Moving forward, maintaining the highest scientific standards is vitally important, in order to protect not only aquatic animal welfare, but also global food security and the welfare of humans. [ABSTRACT FROM AUTHOR]

Published
2024
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48. Ibrutinib dose modifications for management of cardiac adverse events in patients with B-cell malignancies: Pooled analysis of 10 clinical trials.

Author

Stephens, Deborah Marie, primary, Brown, Jennifer R., additional, Ma, Shuo, additional, Wang, Michael, additional, Moreno, Carolina D., additional, Robak, Tadeusz, additional, Stevens, Don A., additional, Li (Lee), Xin (Shane), additional, Saifan, Chadi, additional, Hsu, Emily, additional, Patel, Sima, additional, and Burger, Jan Andreas, additional

Published
2023
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49. Impact of Minimal Residual Disease on Progression-Free Survival Outcomes after Fixed-Duration Ibrutinib-Venetoclax Versus Chlorambucil-Obinutuzumab in the GLOW Study

Author

Munir, Talha, Moreno, Carol, Owen, Carolyn, Follows, George, Benjamini, Ohad, Janssens, Ann, Levin, Mark David, Osterborg, Anders, Robak, Tadeusz, Simkovic, Martin, Stevens, Don, Voloshin, Sergey, Vorobyev, Vladimir, Yagci, Munci, Ysebaert, Loic, Qi, Keqin, Qi, Qianya, Parisi, Lori, Srinivasan, Srimathi, Schuier, Natasha, Baeten, Kurt, Howes, Angela, Caces, Donne Bennett, Niemann, Carsten U., Kater, Arnon P., Munir, Talha, Moreno, Carol, Owen, Carolyn, Follows, George, Benjamini, Ohad, Janssens, Ann, Levin, Mark David, Osterborg, Anders, Robak, Tadeusz, Simkovic, Martin, Stevens, Don, Voloshin, Sergey, Vorobyev, Vladimir, Yagci, Munci, Ysebaert, Loic, Qi, Keqin, Qi, Qianya, Parisi, Lori, Srinivasan, Srimathi, Schuier, Natasha, Baeten, Kurt, Howes, Angela, Caces, Donne Bennett, Niemann, Carsten U., and Kater, Arnon P.

Abstract

PURPOSE In GLOW, fixed-duration ibrutinib + venetoclax showed superior progression-free survival (PFS) versus chlorambucil + obinutuzumab in older/comorbid patients with previously untreated chronic lymphocytic leukemia (CLL). The current analysis describes minimal residual disease (MRD) kinetics and any potential predictive value for PFS, as it has not yet been evaluated for ibrutinib + venetoclax treatment. METHODS Undetectable MRD (uMRD) was assessed by next-generation sequencing at <1 CLL cell per 10,000 (<10−4) and <1 CLL cell per 100,000 (<10−5) leukocytes. PFS was analyzed by MRD status at 3 months after treatment (EOT+3). RESULTS Ibrutinib + venetoclax achieved deeper uMRD (<10−5) rates in bone marrow (BM) and peripheral blood (PB), respectively, in 40.6% and 43.4% of patients at EOT+3 versus 7.6% and 18.1% of patients receiving chlorambucil + obinutuzumab. Of these patients, uMRD (<10−5) in PB was sustained during the first year post-treatment (EOT+12) in 80.4% of patients receiving ibrutinib + venetoclax and 26.3% receiving chlorambucil + obinutuzumab. Patients with detectable MRD (dMRD; ≥10−4) in PB at EOT+3 were more likely to sustain MRD levels through EOT+12 with ibrutinib + venetoclax versus chlorambucil + obinutuzumab. PFS rates at EOT+12 were high among patients treated with ibrutinib + venetoclax regardless of MRD status at EOT+3: 96.3% and 93.3% in patients with uMRD (<10−4) and dMRD (≥10−4) in BM, respectively, versus 83.3% and 58.7% for patients receiving chlorambucil + obinutuzumab. PFS rates at EOT+12 also remained high in patients with unmutated immunoglobulin heavy-chain variable region (IGHV) receiving ibrutinib + venetoclax, independent of MRD status in BM. CONCLUSION Molecular and clinical relapses were less frequent during the first year post-treatment with ibrutinib + venetoclax versus chlorambucil + obinutuzumab regardless of MRD status at EOT+3 and IGHV status. Even for p, PURPOSEIn GLOW, fixed-duration ibrutinib + venetoclax showed superior progression-free survival (PFS) versus chlorambucil + obinutuzumab in older/comorbid patients with previously untreated chronic lymphocytic leukemia (CLL). The current analysis describes minimal residual disease (MRD) kinetics and any potential predictive value for PFS, as it has not yet been evaluated for ibrutinib + venetoclax treatment.METHODSUndetectable MRD (uMRD) was assessed by next-generation sequencing at <1 CLL cell per 10,000 (<10-4) and <1 CLL cell per 100,000 (<10-5) leukocytes. PFS was analyzed by MRD status at 3 months after treatment (EOT+3).RESULTSIbrutinib + venetoclax achieved deeper uMRD (<10-5) rates in bone marrow (BM) and peripheral blood (PB), respectively, in 40.6% and 43.4% of patients at EOT+3 versus 7.6% and 18.1% of patients receiving chlorambucil + obinutuzumab. Of these patients, uMRD (<10-5) in PB was sustained during the first year post-treatment (EOT+12) in 80.4% of patients receiving ibrutinib + venetoclax and 26.3% receiving chlorambucil + obinutuzumab. Patients with detectable MRD (dMRD; ≥10-4) in PB at EOT+3 were more likely to sustain MRD levels through EOT+12 with ibrutinib + venetoclax versus chlorambucil + obinutuzumab. PFS rates at EOT+12 were high among patients treated with ibrutinib + venetoclax regardless of MRD status at EOT+3: 96.3% and 93.3% in patients with uMRD (<10-4) and dMRD (≥10-4) in BM, respectively, versus 83.3% and 58.7% for patients receiving chlorambucil + obinutuzumab. PFS rates at EOT+12 also remained high in patients with unmutated immunoglobulin heavy-chain variable region (IGHV) receiving ibrutinib + venetoclax, independent of MRD status in BM.CONCLUSIONMolecular and clinical relapses were less frequent during the first year post-treatment with ibrutinib + venetoclax versus chlorambucil + obinutuzumab regardless of MRD status at EOT+3 and IGHV status. Even for patients not achieving uMRD (<10-4), PFS rate

Published
2023

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