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2. 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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3. Dual CTLA‐4 and PD‐1 checkpoint blockade using CS1002 and CS1003 (nofazinlimab) in patients with advanced solid tumors: A first‐in‐human, dose‐escalation, and dose‐expansion study.

Author

Bishnoi, Sarwan, Kotasek, Dusan, Aghmesheh, Morteza, Yau, Thomas, Cosman, Rasha, Prawira, Amy, Moore, Maggie, Chan, Stephen L., Mant, Andrew, Eek, Richard, Zielinski, Robert, Su, Rila, Pan, Zhaoxuan, Ma, Yiding, Li, Fei, Li, Peiqi, and Tse, Archie N.

Subjects
CYTOTOXIC T lymphocyte-associated molecule-4, PROGRAMMED cell death 1 receptors, HEREDITARY nonpolyposis colorectal cancer, ADVERSE health care events, MONOCLONAL antibodies, TUMORS
Abstract

Background: This study investigated the safety and efficacy of an anti–CTLA‐4 monoclonal antibody (CS1002) as monotherapy and in combination with an anti–PD‐1 monoclonal antibody (CS1003) in patients with advanced/metastatic solid tumors. Methods: The phase 1 study involved phase 1a monotherapy dose‐escalation (part 1) and phase 1b combination therapy dose escalation (part 2) and expansion (part 3). Various dosing schedules of CS1002 (0.3, 1, or 3 mg/kg every 3 weeks, or 3 mg/kg every 9 weeks) were evaluated with 200 mg CS1003 every 3 weeks in part 3. Results: Parts 1, 2, and 3 included a total of 13, 18, and 61 patients, respectively. No dose‐limiting toxicities or maximum tolerated doses were observed. Treatment‐related adverse events (TRAEs) were reported in 30.8%, 83.3%, and 75.0% of patients in parts 1, 2, and 3, respectively. Grade ≥3 TRAEs were experienced by 15.4%, 50.0%, and 18.3% of patients in each part. Of 61 patients evaluable for efficacy, 23 (37.7%) achieved objective responses in multiple tumor types. Higher objective response rates were observed with conventional and high‐dose CS1002 regimens (1 mg/kg every 3 weeks or 3 mg/kg every 9 weeks) compared to low‐dose CS1002 (0.3 mg/kg every 3 weeks) in microsatellite instability‐high/mismatch repair‐deficient tumors, melanoma, and hepatocellular carcinoma (50.0% vs. 58.8%, 14.3% vs. 42.9%, and 0% vs. 16.7%). Conclusion: CS1002, as monotherapy, and in combination with CS1003, had a manageable safety profile across a broad dosing range. Promising antitumor activities were observed in patients with immune oncology (IO)‐naive and IO‐refractory tumors across CS1002 dose levels when combined with CS1003, supporting further evaluation of this treatment combination for solid tumors. Plain Language Summary: CS1002 is a human immunoglobulin (Ig) G1 monoclonal antibody that blocks the interaction of CTLA‐4 with its ligands and increases T‐cell activation/proliferation. CS1003, now named nofazinlimab, is a humanized, recombinant IgG4 monoclonal antibody that blocks the interaction between human PD‐1 and its ligands.In this original article, we determined the safety profile of CS1002 as monotherapy and in combination with CS1003. Furthermore, we explored the antitumor activity of the combination in anti–programmed cell death protein (ligand)‐1 (PD‐[L]1)‐naive microsatellite instability‐high/mismatch repair‐deficient (MSI‐H/dMMR) pan tumors, and anti–PD‐(L)1‐refractory melanoma and hepatocellular carcinoma (HCC).CS1002 in combination with CS1003 had manageable safety profile across a broad dosing range and showed promising antitumor activities across CS1002 dose levels when combined with CS1003. This supports further assessment of CS1002 in combination with CS1003 for the treatment of solid tumors. This was a phase 1a/1b, dose‐escalation and dose‐expansion study evaluating the safety and efficacy of an anti–CTLA‐4 monoclonal antibody (CS1002) as monotherapy and in combination with an anti–PD‐1 monoclonal antibody (CS1003/nofazinlimab), in patients with advanced/metastatic solid tumors. Promising antitumor activities were observed in heavily pretreated patients with immune oncology (IO)‐naive and IO‐refractory tumors across CS1002 dose levels when combined with CS1003, which supports further assessment of CS1002 in combination with CS1003 for the treatment of solid tumors. [ABSTRACT FROM AUTHOR]

Published
2024
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5. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis

Author

Acar, Kadir, Afanasyev, Boris, Alonso Alonso, Aránzazu, Anttila, Veli-Jukka, Barba Suñol, Pere, Blesing, Norbert, Comeau, Terrance, del Campo, Teresa, Disperati, Patricia, Eek, Richard, Eom, HyeonSeok, Gaidano, Gianluca, Grosicki, Sebastian, Guillaume, Thierry, Homenda, Wojciech, Hwang, William, Ilyin, Nikolay, Johnston, Anna, Kim, Seok Jin, Kuo, Ching-Yuan, Kuvshinov, Aleksey, Lee, Dong-Gun, Lee, Jae Hoon, Lee, Je-Jung, Lepretre, Stephane, Lie, Albert Kwok-Wai, Lucchesi, Alessandro, Masood, Ahmed, Mir, Naheed, Miranda Castillo, Anna Carolina, Mullane, Kathleen, Myasnikov, Alexandr, Oña Navarrete, Raquel, Pauksens, Karlis, Peniket, Andrew, Perez de Oteyza, Jaime, Pohlreich, David, Pullon, Humphrey, Quittet, Philippe, Rodon, Philippe, Rombo, Lars, Samoylova, Olga, Sanmartin Berglund, Johan, Schattner, Ariah, Selleslag, Dominik, Sinisalo, Marjatta, Sultan, Faisal, Theunissen, Koen, Turner, Paul, Wang, Po-Nan, Yáñez San Segundo, Lucrecia, Young, Jo-Anne, Zachee, Pierre, Zaja, Francesco, Dagnew, Alemnew F, Ilhan, Osman, Lee, Won-Sik, Woszczyk, Dariusz, Kwak, Jae-Yong, Bowcock, Stella, Sohn, Sang Kyun, Rodriguez Macías, Gabriela, Chiou, Tzeon-Jye, Quiel, Dimas, Aoun, Mickael, Navarro Matilla, Maria Belen, de la Serna, Javier, Milliken, Samuel, Murphy, John, McNeil, Shelly A, Salaun, Bruno, Di Paolo, Emmanuel, Campora, Laura, López-Fauqued, Marta, El Idrissi, Mohamed, Schuind, Anne, Heineman, Thomas C, Van den Steen, Peter, and Oostvogels, Lidia

Published
2019
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6. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial

Author

Wang, Michael, Rule, Simon, Zinzani, Pier Luigi, Goy, Andre, Casasnovas, Olivier, Smith, Stephen D, Damaj, Gandhi, Doorduijn, Jeanette, Lamy, Thierry, Morschhauser, Franck, Panizo, Carlos, Shah, Bijal, Davies, Andrew, Eek, Richard, Dupuis, Jehan, Jacobsen, Eric, Kater, Arnon P, Le Gouill, Steven, Oberic, Lucie, Robak, Taduesz, Covey, Todd, Dua, Richa, Hamdy, Ahmed, Huang, Xin, Izumi, Raquel, Patel, Priti, Rothbaum, Wayne, Slatter, J Greg, and Jurczak, Wojciech

Published
2018
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8. Multi-Institutional Randomized Phase II Trial of Gefitinib for Previously Treated Patients With Advanced Non–Small-Cell Lung Cancer.

Author

Fukuoka, Masahiro, Yano, Seiji, Giaccone, Giuseppe, Tamura, Tomohide, Nakagawa, Kazuhiko, Douillard, Jean-Yves, Nishiwaki, Yutaka, Vansteenkiste, Johan, Kudoh, Shinzoh, Rischin, Danny, Eek, Richard, Horai, Takeshi, Noda, Kazumasa, Takata, Ichiro, Smit, Egbert, Averbuch, Steven, Macleod, Angela, Feyereislova, Andrea, Dong, Rui-Ping, and Baselga, José

Published
2023
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10. Multi-Institutional Randomized Phase II Trial of Gefitinib for Previously Treated Patients With Advanced Non–Small-Cell Lung Cancer

Author

Fukuoka, Masahiro, Yano, Seiji, Giaccone, Giuseppe, Tamura, Tomohide, Nakagawa, Kazuhiko, Douillard, Jean-Yves, Nishiwaki, Yutaka, Vansteenkiste, Johan, Kudoh, Shinzoh, Rischin, Danny, Eek, Richard, Horai, Takeshi, Noda, Kazumasa, Takata, Ichiro, Smit, Egbert, Averbuch, Steven, Macleod, Angela, Feyereislova, Andrea, Dong, Rui-Ping, and Baselga, José

Published
2003

11. Awareness, preferences, and experiences of thrombosis and thromboprophylaxis in adults commencing systemic anticancer therapies: TARGET-TP trial.

Author

Alexander, Marliese, Harris, Samuel John, Torres, Javier, Underhill, Craig, Sharma, Sharad, Lee, Nora, Wong, Hui-Li, Eek, Richard Wilhelm, Michael, Michael, Tie, Jeanne, Rogers, Jennifer, Patrick, Rachael, Heriot, Alexander Graham, Ball, David, MacManus, Michael Patrick, Wolfe, Rory, Solomon, Benjamin J., and Burbury, Kate

Published
2023
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12. Updated Outcomes and Impact of Age With Lenalidomide and Low-Dose Dexamethasone or Melphalan, Prednisone, and Thalidomide in the Randomized, Phase III FIRST Trial.

Author

Hulin, Cyrille, Belch, Andrew, Shustik, Chaim, Petrucci, Maria Teresa, Dührsen, Ulrich, Jin Lu, Song, Kevin, Rodon, Philippe, Pégourié, Brigitte, Garderet, Laurent, Hunter, Hannah, Azais, Isabelle, Eek, Richard, Gisslinger, Heinz, Macro, Margaret, Dakhil, Shaker, Goncalves, Cristina, LeBlanc, Richard, Romeril, Ken, and Royer, Bruno

Published
2016
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14. Carfilzomib, Thalidomide and Dexamethasone (KTd) is safe and effective in RRMM: interim analysis of the single arm, multicentre phase II ALLG MM018/AMN002 study.

Author

Ninkovic, Slavisa, Chng, Wee Joo, Harrison, Simon J., Murphy, Nick, Lee, Jae Hoon, Estell, Jane, Horvath, Noemi, Eek, Richard, Augustson, Bradley, Kalro, Akash, Rajagopal, Rajeev, Kim, Kihyun, Bang, Soo-Mee, Huang, Shang-Yi, Butcher, Belinda, Durie, Brian, Mollee, Peter, and Quach, Hang

Published
2019
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16. Patients’ and health care professionals’ evaluation of health-related quality of life issues in bone metastases

Author

Harris, Kristin, Chow, Edward, Zhang, Liying, Velikova, Galina, Bezjak, Andrea, Wu, Jackson, Barton, Michael, Sezer, Orhan, Eek, Richard, Shafiq, Jesmin, Yee, Albert, Clemons, Mark, Brundage, Michael, Hoskin, Peter, van der Linden, Yvette, Johnson, Colin D., and Bottomley, Andrew

Subjects
*PHYSICIAN-patient relations, *QUALITY of life, *BONE metastasis, *CANCER patients, *PATIENTS, *HEALTH self-care, *PSYCHOSOCIAL factors, *QUESTIONNAIRES
Abstract

Abstract: The objective of this study was to examine the agreement between health care professionals’ (HCPs) and patients’ evaluation of health-related quality of life (HRQOL) issues for cancer patients with bone metastases. A total of 413 patients and 152 HCPs were interviewed across five centres worldwide. Mean scores were almost always higher for HCPs than for patients. Patients and HCPs agreed that four issues affect HRQOL of bone metastases patients profoundly: ‘long-term (chronic) pain’, ‘difficulty in carrying out usual daily tasks’, ‘able to perform self-care’ and ‘able to perform role functioning’. A substantial difference was found with respect to the perceived importance of psychosocial and somatic issues. Patients emphasised psychosocial issues with a particular focus on ‘worry’ about loss of mobility, dependence on others and disease progression, HCPs however rated ‘symptom’ issues as more important, specifically those related to ‘pain’. In conclusion, patients and HCPs agreed that pain and physical/role functioning are important to the HRQOL of cancer patients with bone metastases, but patients also emphasized the importance of psychosocial issues to HRQOL. This information has been an important component in the development of a health-related quality of life questionnaire for patients with bone metastases (EORTC QLQ-BM 22). [Copyright &y& Elsevier]

Published
2009
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