98 results on '"Andric Z"'
Search Results
2. TTFields (Tumor Treating Fields) associés au traitement standard dans les cancers du poumon non à petites cellules métastatiques en progression après platine : étude internationale, randomisée de phase 3 LUNAR
- Author
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Leal, T., primary, Kotecha, R., additional, Ramlau, R., additional, Zhang, L., additional, Milanowski, J., additional, Cobo, M., additional, Roubec, J., additional, Petruzelka, L., additional, Havel, L., additional, Kalmadi, S., additional, Ward, J., additional, Andric, Z., additional, Berghmans, T., additional, Gerber, D.E., additional, Kloecker, G., additional, Panikkar, R., additional, Aerts, J., additional, Delmonte, A., additional, Pless, M., additional, and Langer, C., additional
- Published
- 2024
- Full Text
- View/download PDF
3. OA01.04 Five-Year Survival in Patients with ES-SCLC Treated with Atezolizumab in IMpower133: Imbrella a Extension Study Results
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Liu, S.V., primary, Dziadziuszko, R., additional, Sugawara, S., additional, Kao, S., additional, Hochmair, M., additional, Huemer, F., additional, Castro, G., additional, Havel, L., additional, Caro, R.B., additional, Losonczy, G., additional, Lee, J.-S., additional, Kowalski, D., additional, Andric, Z., additional, Califano, R., additional, Veatch, A., additional, Gerstner, G., additional, Batus, M., additional, Morris, S., additional, Kaul, M., additional, Siddiqui, M., additional, Li, H., additional, Zhang, W., additional, Nabet, B., additional, and Reck, M., additional
- Published
- 2023
- Full Text
- View/download PDF
4. OA22.05 TTFields and Immune-Checkpoint Inhibitor in Metastatic Non-Small Cell Lung Cancer: PD-L1 Subgroups in the Phase 3 LUNAR Study
- Author
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Leal, T., primary, Kotecha, R., additional, Ramlau, R., additional, Zhang, L., additional, Milanowski, J., additional, Cobo, M., additional, Roubec, J., additional, Petruzelka, L., additional, Havel, L., additional, Kalmadi, S., additional, Ward, J., additional, Andric, Z., additional, Berghmans, T., additional, Gerber, D.E., additional, Kloecker, G., additional, Panikkar, R., additional, Aerts, J., additional, Delmonte, A., additional, Pless, M., additional, Greil, R., additional, Rolfo, C., additional, Akerley, W., additional, Eaton, M., additional, Iqbal, M., additional, and Langer, C., additional
- Published
- 2023
- Full Text
- View/download PDF
5. A randomized phase II study of ganetespib, a heat shock protein 90 inhibitor, in combination with docetaxel in second-line therapy of advanced non-small cell lung cancer (GALAXY-1)
- Author
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Ramalingam, S., Goss, G., Rosell, R., Schmid-Bindert, G., Zaric, B., Andric, Z., Bondarenko, I., Komov, D., Ceric, T., Khuri, F., Samarzija, M., Felip, E., Ciuleanu, T., Hirsh, V., Wehler, T., Spicer, J., Salgia, R., Shapiro, G., Sheldon, E., Teofilovici, F., Vukovic, V., and Fennell, D.
- Published
- 2015
- Full Text
- View/download PDF
6. Long-term (180-day) outcomes in critically ill patients with COVID-19 in the REMAP-CAP randomized clinical trial
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Florescu, S, Stanciu, D, Zaharia, M, Kosa, A, Codreanu, D, Kidwai, A, Masood, S, Kaye, C, Coutts, A, MacKay, L, Summers, C, Polgarova, P, Farahi, N, Fox, E, McWilliam, S, Hawcutt, D, Rad, L, O’Malley, L, Whitbread, J, Jones, D, Dore, R, Saunderson, P, Kelsall, O, Cowley, N, Wild, L, Thrush, J, Wood, H, Austin, K, Bélteczki, J, Magyar, I, Fazekas, Á, Kovács, S, Szőke, V, Donnelly, A, Kelly, M, Smyth, N, O’Kane, S, McClintock, D, Warnock, M, Campbell, R, McCallion, E, Azaiz, A, Charron, C, Godement, M, Geri, G, Vieillard-Baron, A, Johnson, P, McKenna, S, Hanley, J, Currie, A, Allen, B, McGoldrick, C, McMaster, M, Mani, A, Mathew, M, Kandeepan, R, Vignesh, C, TV, B, Ramakrishnan, N, James, A, Elvira, E, Jayakumar, D, Pratheema, R, Babu, S, Ebenezer, R, Krishnaoorthy, S, Ranganathan, L, Ganesan, M, Shree, M, Guilder, E, Butler, M, Cowdrey, K-A, Robertson, M, Ali, F, McMahon, E, Duffy, E, Chen, Y, Simmonds, C, McConnochie, R, O’Connor, C, El-Khawas, K, Richardson, A, Hill, D, Commons, R, Abdelkharim, H, Saxena, M, Muteithia, M, Dobell-Brown, K, Jha, R, Kalogirou, M, Ellis, C, Krishnamurthy, V, O’Connor, A, Thurairatnam, S, Mukherjee, D, Kaliappan, A, Vertue, M, Nicholson, A, Riches, J, Maloney, G, Kittridge, L, Solesbury, A, Ramos, A, Collins, D, Brickell, K, Reid, L, Smyth, M, Breen, P, Spain, S, Curley, G, McEvoy, N, Geoghegan, P, Clarke, J, Silversides, J, McGuigan, P, Ward, K, O’Neill, A, Finn, S, Wright, C, Green, J, Collins, É, Knott, C, Smith, J, Boschert, C, Slieker, K, Ewalds, E, Sanders, A, Wittenberg, W, Geurts, H, Poojara, L, Sara, T, Nand, K, Reeve, B, Dechert, W, Phillips, B, Oritz-Ruiz de Gordoa, L, Affleck, J, Shaikh, A, Murray, A, Ramanan, M, Frakking, T, Pinnell, J, Robinson, M, Gledhill, L, Wood, T, Sanghavi, R, Bhonagiri, D, Ford, M, Parikh, HG, Avard, B, Nourse, M, McDonald, B, Edmunds, N, Hoiting, O, Peters, M, Rengers, E, Evers, M, Prinssen, A, Morgan, M, Cole, J, Hill, H, Davies, M, Williams, A, Thomas, E, Davies, R, Wise, M, Grimm, P, Soukup, J, Wetzold, R, Löbel, M, Starke, L, Lellouche, F, Lizotte, P, Declerq, P, Antoine, M, Stephanie, G, Jean-Pierre, E, François, B, Marion, B, Philippe, R, Pourcine, F, Monchi, M, Luis, D, Mercier, R, Sagnier, A, Verrier, N, Caplin, C, Richecoeu, J, Combaux, D, Siami, S, Aparicio, C, Vautier, S, Jeblaoui, A, Lemaire-Brunel, D, D'Aragon, F, Carbonneau, E, Leblond, J, Plantefeve, G, Leparco, C, Contou, D, Fartoukh, M, Courtin, L, Labbe, V, Voiriot, G, Salhi, S, Chassé, M, Carrier, F, Boumahni, D, Benettaib, F, Ghamraoui, A, Sement, A, Gachet, A, Hanisch, A, Haffiane, A, Boivin, A-H, Barreau, A, Guerineau, E, Poupblanc, S, Egreteau, P, Lefevre, M, Bocher, S, Le Loup, G, Le Guen, L, Carn, V, Bertel, M, Antcliffe, D, Templeton, M, Rojo, R, Coghlan, P, Smee, J, Barker, G, Finn, A, Kreb, G, Hoff, U, Hinrichs, C, Nee, J, Mackay, E, Cort, J, Whileman, A, Spencer, T, Spittle, N, Beavis, S, Padmakumar, A, Dale, K, Hawes, J, Moakes, E, Gascoyne, R, Pritchard, K, Stevenson, L, Cooke, J, Nemeth-Roszpopa, K, Gauli, B, Bastola, S, Muller, G, Nay, M-A, Kamel, T, Benzekri, D, Jacquier, S, Runge, I, Mathonnet, A, Barbier, F, Bretagnol, A, Carter, J, Van Der Heyden, K, Mehrtens, J, Morris, A, Morgan, S, Burke, T, Mercier, E, Chartier, D, Salmon, C, Dequin, P-F, Garot, D, Bellemare, D, Cloutier, È, Daher, R, Costerousse, O, Boulanger, M-C, Couillard-Chénard, É, Lauzier, F, Francoeur, C, Francois, B, Gay, A, Anne-Laure, F, Ramali, M, HC, O, Ghosh, A, Osagie, R, Arachchige, M, Hartley, M, Cheung, W, Wong, H, Seigne, P, Eustace, J, O'Callaghan, A-M, O'Brien, F, Bamford, P, Reid, A, Cawley, K, Faulkner, M, Pickering, C, Raj, A, Tsinaslanidis, G, Khade, R, Agha, G, Sekiwala, R, Smith, T, Brewer, C, Gregory, J, Limb, J, Cowton, A, O’Brien, J, Postlethwaite, K, Malakouti, S, Music, E, Ricketts, D, King, A, Clermont, G, Bart, R, Mayr, F, Schoenling, A, Andreae, M, Shetty, V, Brant, E, Malley, B, Donadee, C, Sackrowitz, R, Weissman, A, Yealy, D, Barton, D, Talia, N, Nikitas, N, Wells, C, Lankester, L, McMillan, H, Van den Oever, H, Kruisdijk-Gerritsen, A, Haidar, G, Bain, W, Barbash, I, Fitzpatrick, M, Franz, C, Kitsios, G, Moghbeli, K, Rosborough, B, Shah, F, Suber, T, Pulletz, M, Williams, P, Birch, J, Wiseman, S, Horton, S, Alegria, A, Turki, S, Elsefi, T, Crisp, N, Allen, L, Truman, N, Smith, M, Chukkambotla, S, Goddard, W, Duberley, S, Khan, M, Kazi, A, Simpson, J, Duke, G, Chan, P, Carter, B, Hunter, S, Voigt, I, Schueler, R, Blank, E, Hüning, V, Steffen, M, Goralski, P, Litton, E, Regli, A, Pellicano, S, Palermo, A, Eroglu, E, Bihari, S, Laver, RD, Jin, X, Brown, J, McIntyre, J, French, C, Bates, S, Towns, M, Yang, Y, McGain, F, McCullagh, I, Cairns, T, Hanson, H, Patel, B, Clement, I, Evetts, G, Touma, O, Holland, S, Hodge, C, Taylor, H, Alderman, M, Barnes, N, Da Rocha, J, Smith, C, Brooks, N, Weerasinghe, T, Sinclair, J-A, Abusamra, Y, Doherty, R, Cudlipp, J, Singh, R, Yu, H, Daebis, A, Ng, C, Kendrick, S, Saran, A, Makky, A, Greener, D, Rowe-Leete, L, Edwards, A, Bland, Y, Dolman, R, Foster, T, Laffey, J, McNicholas, B, Scully, M, Casey, S, Kernan, M, Brennan, A, Rangan, R, Tully, R, Corbett, S, McCarthy, A, Duffy, O, Burke, D, Linnett, V, Sanderson, A, Ritzema, J, Wild, H, Lucas, R, Marriott, Y, Andric, Z, Cviljevic, S, Br, R, Zapalac, M, Mirković, G, Khare, D, Pinder, M, Gopinath, A, Kannan, T, Dean, S, Vanmali, P, Depuydt, P, De Waele, J, De Bus, L, Fierens, J, Bracke, S, Vermassen, J, Vermeiren, D, Pugh, R, Lean, R, Qiu, X, Scanlan, J, Evans, A, Davies, G, Lewis, J, Plesnikova, Y, Khoud, A, Coetzee, S, Puxty, K, Cathcart, S, Rimmer, D, Bagot, C, Scott, K, Martin, L, Yusuff, H, Isgro, G, Brightling, C, Bourne, M, Craner, M, Boyles, R, Alexander, B, Roberts, T, Nelli, A, Rosenstein-Sisson, R, Speyer, R, Pech, Y, McCullough, J, Tallott, M, Vazquez-Grande, G, Marten, N, Liu, T, Siddiqui, A, Khanal, S, Amatya, S, Szakmany, T, Cherian, S, Williams, G, James, C, Waters, A, Prout, R, Stedman, R, Davies, L, Pegler, S, Kyeremeh, L, Moorhouse, L, Arbane, G, Marotti, M, Bociek, A, Campos, S, Van Nieuwkoop, K, Ottens, T, Visser, Y, Van den Berg, L, Van der Kraan-Donker, A, Brett, S, Arias, S, Hall, R, Paneru, H, Koirala, S, Paudel, P, Wilson, M, Vaara, S, Pettilä, L, Heinonen, J, Pettilä, V, Jain, S, Gupta, A, Holbrook, C, Antoine, P, Meziani, F, Allam, H, Cattelan, J, Clere-Jehl, R, Helms, J, Kummerlen, C, Merdji, H, Monnier, A, Rahmani, H, Studer, A, Schneider, F, Castelain, V, Morel, G, L’Hotellier, S, Ochin, E, Vanjak, C, Rouge, P, Bendjemar, L, Albert, M, Serri, K, Cavayas, A, Duplaix, M, Williams, V, Catorze, NJTADS, Pereira, TNAL, Ferreira, RMC, Bastos, JMPS, Batista, TMO, Badie, J, Berdaguer, F, Malfroy, S, Mezher, C, Bourgoin, C, Moneger, G, Bouvier, E, Muñoz-Bermúdez, R, Marin-Corral, J, Degracia, A, Gómez, F, López, M, Aceto, R, Aghemo, A, Badalamenti, S, Brunetta, E, Cecconi, M, Ciccarelli, M, Constantini, E, Greco, M, Folci, M, Selmi, C, Voza, A, Henning, J, Bonner, S, Hugill, K, Cirstea, E, Wilkinson, D, Jones, J, Altomy, M, Karlikowski, M, Sutherland, H, Wilhelmsen, E, Woods, J, North, J, Pletz, M, Hagel, S, Ankert, J, Kolanos, S, Bloos, F, Simons, K, Van Zuylen, T, Bouman, A, Kumar, N, Panwar, R, Poulter, A-L, Sunkara, K, Szigligeti, G, Leszkoven, J, Rochwerg, B, Karachi, T, Oczkowski, S, Centofanti, J, Millen, T, Sundaran, D, Hollos, L, Turns, M, Walsh, J, Al Qasim, E, Alswaidan, L, Hegazy, M, Arishi, H, Al Amri, A, AlQahtani, S, Naidu, B, Tlayjeh, H, Hussain, S, Al Enezi, F, Abdukahil, SA, Hopkins, P, Noble, H, O’Reilly, K, Mehta, R, Wong, O, Makanju, E, Rao, D, Sikondari, N, Saha, S, Corcoran, E, Pappa, E, Cockrell, M, Donegan, C, Balaie, M, Nickoleit-Bitzenberger, D, Schaaf, B, Meermeier, W, Prebeg, K, Azzaui, H, Hower, M, Brieger, K-G, Elender, C, Sabelhaus, T, Riepe, A, Akamp, C, Kremling, J, Klein, D, Landsiedel-Mechenbier, E, Laha, S, Verlander, M, Jha, A, Megarbane, B, Voicu, S, Deye, N, Malissin, I, Sutterlin, L, Mrad, A, Lehalleur, A, Naim, G, Nguyen, P, Ekhérian, J-M, Boué, Y, Sidéris, G, Vodovar, D, Guérin, E, Grant, C, Brain, M, Mineall, S, Paramasivam, E, Wilby, E, Ogg, B, Howcroft, C, Aspinwall, A, Charlton, S, Gould, R, Mistry, D, Awan, S, Bedford, C, Carr-Wilkinson, J, Hall, A, Gardiner-Hill, C, Maloney, C, Brunskill, N, Watchorn, O, Hardy, C, Qureshi, H, Flint, N, Nicholson, S, Southin, S, Ghattaoraya, A, Harding, D, O’Halloran, S, Collins, A, Smith, E, Trues, E, Borgatta, B, Turner-Bone, I, Reddy, A, Wilding, L, Wilson, C, Surti, Z, Aneman, A, Miller, J, White, H, Estensen, K, Morrison, L, Sutton, J, Cooper, M, Warnapura, L, Agno, R, Sathianathan, P, Shaw, D, Ijaz, N, Spong, A, Sabaretnam, S, Burns, D, Lang, E, Tate, M, Fischer, R, Biradar, V, Soar, N, Golden, D, Davey, M, Seaman, R, Osborne, A, Bannard-Smith, J, Clark, R, Birchall, K, Henry, J, Pomeroy, F, Quayle, R, Wylie, K, Sukuraman, A, John, M, Sibin, S, Leditschke, A, Finnis, M, Jongebloed, K, Khwaja, K, Campisi, J, Van Vonderen, M, Pietersma, M, Vrolijk, L, Kampschreur, L, Van Gulik, L, Makowski, A, Misztal, B, Haider, S, Liao, A, Squires, R, Oborska, A, Kayani, A, Kalchko-Veyssal, S, Prabakaran, R, Hadebe, B, KalchkoVeyssal, S, Williams, T, Song, R, Morpeth, S, Lai, V, Habraken, H, Stewart, R, Mwaura, E, Mew, L, Wren, L, Willams, F, Sutherland, S-B, Rebello, R, Shehabi, Y, Al-Bassam, W, Hulley, A, Kadam, U, Sathianathan, K, Innes, R, Doble, P, Graham, L, Shovelton, C, Dean, T, Salahuddin, N, Aryal, D, Koirala, K, Rai, N, Luitel, S, Seppelt, I, Whitehead, C, Lowrey, J, Gresham, R, Masters, K, Hamlyn, V, Hawkins, N, Roynon-Reed, A, Cutler, S, Lewis, S, Lazaro, J, Newman, T, Aravindan, L, Asghar, A, Bartholomew, J, Bayne, M, Beddows, S, Birch, C, Brend, M, Byrne, R, Campbell, D, Campbell, H, Chambers, E, Clinton, A, Collins, J, Crawshaw, S, Dawson, LA, Donaldson, K, Drake, C, Dyas, S, Ellis, Y, Gilmour, K, Goodwin, J, Halden, S, Hall, AS, Hanson, J, Harper, H, Harrison, S, Hayes, A, Hodgson, H, Hurford, S-A, Jackson, S, Levett, C, Lock, S, Lockett, T, Logan, M, Lomme, K, Luo, J, Marsh, E, Mguni, N, Monaghan, H, Murphy, S, Muzengi, N, Naz, M, O'Kell, E, Oliver, A, O'Reilly, J, Pearson, K, Porter, D, Potter, A, Rook, C, Rounds, C, Sheffield, J, Shirley, K, Siewersk, C, Skinner, T, Speight, H, Sutu, M, Unsworth, A, Van’t Hoff, W, Walker, S, Williams, H, Williamson, D, Williamson, JD, Duan, E, Tsang, J, Patterson, L, Austin, P, Chapman, S, Cabrelli, L, Fletcher, S, Nortje, J, Fottrell-Gould, D, Randell, G, Stammers, K, Healey, G, Pinto, M, Borrill, Z, Duncan, T, Ustianowski, A, Uriel, A, Eltayeb, A, Alfonso, J, Hey, S, Shaw, J, Fox, C, Lindergard, G, Charles, B, Blackledge, B, Connolly, K, Harris, J, Cuesta, J, Xavier, K, Purohit, D, Elhassan, M, Haldeos, A, Vincent, R, Abdelrazik, M, Jenkins, S, Ganesan, A, Kumar, R, Carter, D, Bakthavatsalam, D, Frater, A, Saleem, M, Everitt, R, Hacking, D, Zaman, M, Elmahi, E, Jones, A, Hall, K, Phillips, M, Terrill, L, Mills, G, Raithatha, A, Bauchmuller, K, Ryalls, K, Harrington, K, Bowler, H, Sall, J, Bourne, R, Gross, J, Massey, N, Adebambo, O, Long, M, Tony, K, Juffermans, N, Koopmans, M, Dujardin, R, Alderink, B, Rowland, M, Hutton, P, Bashyal, A, Davidson, N, Hird, C, Chhablani, M, Phalod, G, Kirkby, A, Archer, S, Netherton, K, Reschreiter, H, Camsooksai, J, Patch, S, Humphrey, C, Flynn, G, Harrington, C, Kruger, P, Walsham, J, Meyer, J, Harward, M, Jones, C, Sathe, S, Roche, L, Davies, E, Skinner, D, Gaylard, J, Newman, J, Pogson, D, Rose, S, Daly, Z, Brimfield, L, Nown, A, Parekh, D, Bergin, C, Bates, M, McGhee, C, Lynch, D, Bhandal, K, Tsakiridou, K, Bamford, A, Cooper, L, Whitehouse, T, Veenith, T, Forster, E, O'Connell, M, Sim, M, Hay, S, Henderson, S, Nygren, M, Valentine, E, Katary, A, Bell, G, Wilcox, L, Mataliotakis, M, Smith, P, Ali, M, Isguzar, A, Phull, M-K, Zaidi, A, Pogreban, T, Rosaroso, L, Harvey, D, Lowe, B, Meredith, M, Ryan, L, Schouten, J, Pickkers, P, Roovers, N, Klop-Riehl, M, Van der Eng, H, Sloots-Cuppen, S, Preijers, L, Van Oosten, N, Moine, P, Heming, N, Maxime, V, Bossard, I, Nicholier, T, Clair, B, Orlikowski, D, Bounab, R, Abdeladim, L, Baker, S, Duroux, M, Ratcliffe, M, Sy, E, Mailman, J, Lee, S, Gupta, C, Kassir, S, López, R, Rodríguez-Gómez, J, Cárcel, S, Carmona, R, De la Fuente, C, Rodriguez, M, Jan Hassing, R, Greven, F, Huijbens, D, Roebers, L, Verheij, H, Miles, H, Attokaran, A, Buehner, U, Williams, E, Chapman, M, O’Connor, S, Glasby, K, Rivett, J, Brown, N, Kutsogiannis, D, Thompson, P, Rooney, K, Rodden, N, Thomson, N, McGlynn, D, Abel, L, Gemmell, L, Sundaram, R, Hornsby, J, Walden, A, Keating, L, Frise, M, Rai, S, Bartley, S, Schuster-Bruce, M, Pitts, S, Miln, R, Purandare, L, Vamplew, L, Dempster, D, Gummadi, M, Dormand, N, Wang, S, Spivey, M, Bean, S, Burt, K, Moore, L, Hammonds, F, Richards, C, Campbell, L, Smyth, K, Day, C, Zitter, L, Benyon, S, Singh, J, Lynch, C, Mikusek, J, Deacon, B, Turner, K, Baker, E, Hickey, J, Champanerkar, S, Aitken, L, LewisProsser, L, Ahmad, N, Wiles, M, Willson, J, Grecu, I, Martin, J, Wrey Brown, C, Arias, A-M, Bevan, E, Westlake, S, Craven, T, Hope, D, Singleton, J, Clark, S, McCulloch, C, Biddie, S, Welters, I, Hamilton, D, Williams, K, Waugh, V, Mulla, S, Waite, A, Roman, J, Martinez, M, Johnston, B, Puthucheary, Z, Martin, T, Santos, F, Uddin, R, Fernandez, M, Seidu, F, Somerville, A, Pakats, M-L, Begum, S, Shahid, T, Presneill, J, Barge, D, Byrne, K, Janin, P, Yarad, E, Bass, F, Hammond, N, Vuylsteke, A, Chan, C, Victor, S, Waterson, S, McNamara, R, Boardman, M, Gattas, D, Buhr, H, Coles, J, Matsa, R, Gellamucho, M, Creagh-Brown, B, Marriot, C, Salberg, A, Zouita, L, Stone, S, Michalak, N, Donlon, S, Mtuwa, S, Mayangao, I, Verula, J, Burda, D, Harris, C, Jones, E, Bradley, P, Tarr, E, Harden, L, Piercy, C, Nolan, J, Kerslake, I, Cook, T, Simpson, T, Dalton, J, Demetriou, C, Mitchard, S, Ramos, L, White, K, Johnson, T, Headdon, W, Spencer, S, White, A, Howie, L, Reay, M, Watts, A, Traverse, E, Jennings, S, Anumakonda, V, Tuckwell, C, Harrow, K, Matthews, J, McGarry, K, Moore, V, Smith, L, Summerfield, A, Dark, P, Harvey, A, Doonan, R, McMorrow, L, Knowles, K, Pendlebury, J, Perez, J, Marsden, T, Taylor, M, Michael, A, Collis, M, Claxton, A, Habeichi, W, Horner, D, Slaughter, M, Thomas, V, Proudfoot, N, Keatley, C, Donnison, P, Casey, R, Irving, B, Matimba-Mupaya, W, Reed, C, Anthony, A, Trim, F, Cambalova, L, Robertson, D, Wilson, A, Hulme, J, Kannan, S, Kinney, F, Senya, H, Ratnam, V, Gill, M, Kirk, J, Shelton, S, Schweikert, S, Wibrow, B, Anstey, M, Rauniyar, R, Khoso, N, Asif, N, Taqdees, H, Frey, C, Scano, R, McKee, M, Murphy, P, Thomas, M, Worner, R, Faulkner, B, Gendall, E, Hayes, K, Blakemore, H, Borislavova, B, Deshpande, K, Van Haren, F, Konecny, P, Inskip, D, Tung, R, Hayes, L, Murphy, L, Neill, A, Reidy, B, O’Dwyer, M, Ryan, D, Ainscough, K, Hamilton-Davies, C, Mfuko, C, Abbass, H, Mandadapu, V, Leaver, S, Patel, K, Farnell-Ward, S, Saluzzio, R, Rawlins, S, Sicat, C, De Keulenaer, B, Ferrier, J, Fysh, E, Davda, A, Mevavala, B, Cook, D, Clarke, F, Banach, D, Fernández de Pinedo Artaraz, Z, Cabreros, L, Latham, V, Kruisselbrink, R, Brochard, L, Burns, K, Sandhu, G, Khalid, I, White, I, Croft, M, Holland, N, Pereira, R, Nair, P, Buscher, H, Reynolds, C, Newman, S, Santamaria, J, Barbazza, L, Homes, J, Smith, R, Zaki, A, Johnson, D, Garrard, H, Juhaz, V, Brown, L, Pemberton, A, Roy, A, Rostron, A, Woods, L, Cornell, S, Fowler, R, Adhikari, N, Kamra, M, Marinoff, N, Garrett, P, Murray, L, Brailsford, J, Fennessy, G, Mulder, J, Morgan, R, Pillai, S, Harford, R, Ivatt, H, Evans, D, Richards, S, Roberts, E, Bowen, J, Ainsworth, J, Kuitunen, A, Karlsson, S, Vahtera, A, Kiiski, H, Ristimäki, S, Albrett, J, Jackson, C, Kirkham, S, Tamme, K, Reinhard, V, Ellervee, A, Põldots, L, Rennit, P, Svitškar, N, Browne, T, Grimwade, K, Goodson, J, Keet, O, Callender, O, Udy, A, McCracken, P, Young, M, Board, J, Martin, E, Kasipandian, V, Patel, A, Allibone, S, Mary-Genetu, R, English, S, Watpool, I, Porteous, R, Miezitis, S, McIntyre, L, Brady, K, Vale, C, Shekar, K, Lavana, J, Parmar, D, Peake, S, Kurenda, C, Hormis, A, Walker, R, Collier, D, Kimpton, S, Oakley, S, Bhagani, S, De Neef, M, Garcia, S, Maharajh, A, Nandani, A, Dobson, J, Fernando, G, Eastgate, C, Gomez, K, Abdi, Z, Tatham, K, Jhanji, S, Black, E, Dela Rosa, A, Howle, R, Baikady, R, Drummond, A, Dearden, J, Philbin, J, Munt, S, Gopal, S, Pooni, J-S, Ganguly, S, Smallwood, A, Metherell, S, Naeem, A, Fagan, L, Ryan, E, Mariappa, V, Foulds, A, Revill, A, Bhattarai, B, De Jonge, E, Wigbers, J, Del Prado, M, Cremer, O, Mulier, J, Peters, A, Romberg, B, Schutgens, R, Troeman, D, Van Opdorp, M, Besten, H, Brakké, K, Barber, R, Hilldrith, A, Kluge, S, Nierhaus, A, Jarczak, D, Roedl, K, Kochanek, M, Rueß-Paterno, G, Mc-Kenzie, J, Eichenauer, D, Shimabukuro-Vornhagen, A, Wilcox, E, Del Sorbo, L, Abdelhady, H, Romagnuolo, T, Simpson, S, Maiden, M, Horton, M, Trickey, J, Krajinovic, V, Kutleša, M, Kotarski, V, Brohi, F, Jagannathan, V, Clark, M, Purvis, S, Wetherill, B, Brajković, A, Babel, J, Sever, H, Dragija, L, Kušan, I, Dushianthan, A, Cusack, R, De Courcy-Golder, K, Salmon, K, Burnish, R, Smith, S, Ruiz, W, Duke, Z, Johns, M, Male, M, Gladas, K, Virdee, S, Swabe, J, Tomlinson, H, Rohde, G, Grünewaldt, A, Bojunga, J, Petros, S, Kunz, K, Schütze, B, Weismann, D, Frey, A, Drayss, M, Goebeler, ME, Flor, T, Fragner, G, Wahl, N, Totzke, J, Sayehli, C, Hakak, S, Altaf, W, O'Sullivan, M, Murphy, A, Walsh, L, Rega La Valle, A, Bewley, J, Sweet, K, Grimmer, L, Johnson, R, Wyatt, R, Morgan, K, Varghese, S, Willis, J, Stratton, E, Kyle, L, Putensen, D, Drury, K, Skorko, A, Bremmer, P, Ward, G, Bassford, C, Sligl, W, Baig, N, Rewa, O, Bagshaw, S, Basile, K, Stavor, D, Burbee, D, McNamara, A, Wunderley, R, Bensen, N, Adams, P, Vita, T, Buhay, M, Scholl, D, Gilliam, M, Winters, J, Doherty, K, Berryman, E, Ghaffari, M, Marroquin, O, Quinn, K, Garrard, W, Kalchthaler, K, Beard, G, Skrtich, A, Bagavathy, K, Drapola, D, Bryan-Morris, K, Arnold, J, Reynolds, B, Hussain, M, Dunsavage, J, Saiyed, S, Hernandez, E, Goldman, J, Brown, C, Comp, S, Raczek, J, Morris, J, Vargas Jr., J, Weiss, D, Hensley, J, Kochert, E, Wnuk, C, Nemeth, C, Mowery, B, Hutchinson, C, Winters, L, McAdams, D, Walker, G, Minnier, T, Wisniewski, M, Mayak, K, McCreary, E, Bariola, R, Viehman, A, Daley, J, Lopus, A, Schmidhofer, M, Ambrosino, R, Keen, S, Toffalo, S, Stambaugh, M, Trimmer, K, Perri, R, Casali, S, Medva, R, Massar, B, Beyerl, A, Burkey, J, Keeler, S, Lowery, M, Oncea, L, Daugherty, J, Sevilla, C, Woelke, A, Dice, J, Weber, L, Roth, J, Ferringer, C, Beer, D, Fesz, J, Carpio, L, Colin, G, Zinzoni, V, Maquigneau, N, Henri-Lagarrigue, M, Pouplet, C, Reill, L, Distler, M, Maselli, A, Martynoga, R, Trask, K, Butler, A, Attwood, B, Parsons, P, Campbell, B, Smith, A, Page, V, Zhao, X, Oza, D, Abrahamson, G, Sheath, B, Young, P, Young, C, Lesona, E, Navarra, L, Cruz, R, Delaney, K, Aguilar-Dano, A, Gojanovic, M, Rhodes, J, Anderson, T, Morris, S, Nayyar, V, Bowen, D, Kong, J, Joy, J, Fuchs, R, Lambert, B, Tai, C, Thomas, A, Keen, A, Tierney, C, Omer, N, Bacon, G, Tridente, A, Shuker, K, Anders, J, Greer, S, Scott, P, Millington, A, Buchanan, P, Binnie, A, Powell, E, McMillan, A, Luk, T, Aref, N, Denmade, C, Sadera, G, Jacob, R, Hughes, D, Sterba, M, Geng, W, Digby, S, Southern, D, Reddy, H, Hulse, S, Campbell, A, Garton, M, Watkins, C, Smuts, S, Quinn, A, Simpson, B, McMillan, C, Finch, C, Hill, C, Cooper, J, Budd, J, Small, C, O’Leary, R, Collins, E, Holland, A, Alexander, P, Felton, T, Ferguson, S, Sellers, K, Ward, L, Yates, D, Birkinshaw, I, Kell, K, Scott, Z, Pearson, H, Hashmi, M, Hassan, N, Panjwani, A, Umrani, Z, Shaikh, M, Ain, Q, Kanwal, D, Van Bree, S, Bouw-Ruiter, M, Osinga, M, Van Zanten, A, McEldrew, R, Rashan, S, Singh, V, Azergui, N, Bari, S, Beltran, M, Brugman, C, Groeneveld, E, Jafarzadeh, M, Keijzer-Timmers, N, Kester, E, Koelink, M, Kwakkenbos-Craanen, M, Okundaye, C, Parker, L, Peters, S, Post, S, Rietveld, I, Scheepstra-Beukers, I, Schreuder, G, Smit, A, Brillinger, N, Markgraf, R, Eichinger, F, Doran, P, Anjum, A, Best-Lane, J, Barton, F, Miller, L, Richards-Belle, A, Saull, M, Sprinckmoller, S, Wiley, D, Darnell, R, Au, C, Lindstrum, K, Cheng, A, Forbes, A, Heritier, S, Trapani, T, Cuthbertson, B, Manoharan, V, Dondrop, A, Tolppa, T, Ehrmann, S, Hullegie, S, Povoa, P, Beasley, R, Daneman, N, McGloughlin, S, Paterson, D, Venkatesh, B, De Jong, M, Uyeki, T, Baillie, K, Netea, M, Orr, K, Patanwala, A, Tong, S, Cooper, N, Galea, J, Leavis, H, Ogungbenro, K, Patawala, A, Rademaker, E, Youngstein, T, Carrier, M, Fergusson, D, Hunt, B, Kumar, A, Laffan, M, Lother, S, Middeldorp, S, Stanworth, S, De Man, A, Masse, M-H, Abraham, J, Arnold, D, Begin, P, Charlewood, R, Chasse, M, Coyne, M, Daly, J, Gosbell, I, Harvala-Simmonds, H, MacLennan, S, McDyer, J, Menon, D, Pridee, N, Roberts, D, Thomas, H, Tinmouth, A, Triulzi, D, Walsh, T, Wood, E, Calfee, C, O’Kane, C, Shyamsundar, M, Sinha, P, Thompson, T, Young, I, Burrell, A, Ferguson, N, Hodgson, C, Orford, N, Phua, J, Baron, R, Epelman, S, Frankfurter, C, Gommans, F, Kim, E, Leaf, D, Vaduganathan, M, Van Kimmenade, R, Sanil, A, Van Beurden, M, Effelaar, E, Schotsman, J, Boyd, C, Harland, C, Shearer, A, Wren, J, Attanayaka, U, Darshana, S, Ishani, P, Udayanga, I, Higgins, AM, Berry, LR, Lorenzi, E, Murthy, S, McQuilten, Z, Mouncey, PR, Al-Beidh, F, Annane, D, Arabi, YM, Beane, A, Van Bentum-Puijk, W, Bhimani, Z, Bonten, MJM, Bradbury, CA, Brunkhorst, FM, Buzgau, A, Buxton, M, Charles, WN, Cove, M, Detry, MA, Estcourt, LJ, Fagbodun, EO, Fitzgerald, M, Girard, TD, Goligher, EC, Goossens, H, Haniffa, R, Hills, T, Horvat, CM, Huang, DT, Ichihara, N, Lamontagne, F, Marshall, JC, McAuley, DF, McGlothlin, A, McGuinness, SP, McVerry, BJ, Neal, MD, Nichol, AD, Parke, RL, Parker, JC, Parry-Billings, K, Peters, SEC, Reyes, LF, Rowan, KM, Saito, H, Santos, MS, Saunders, CT, Serpa-Neto, A, Seymour, CW, Shankar-Hari, M, Stronach, LM, Turgeon, AF, Turner, AM, Van de Veerdonk, FL, Zarychanski, R, Green, C, Lewis, RJ, Angus, DC, McArthur, CJ, Berry, S, Derde, LPG, Gordon, AC, Webb, SA, Lawler, PR, Comm REMAP-CAP Investigators, Apollo - University of Cambridge Repository, Intensive Care Medicine, Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Hôpital Raymond Poincaré [Garches], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Pittsburgh Foundation, PF, Amgen, Health Research Board, HRB: CTN 2014-012, Horizon 2020 Framework Programme, H2020: 101003589, Translational Breast Cancer Research Consortium, TBCRC, Canadian Institutes of Health Research, IRSC: 158584, Heart and Stroke Foundation of Canada, HSF, National Institute for Health and Care Research, NIHR, European Commission, EC, National Health and Medical Research Council, NHMRC: 1101719, APP194811, CS-2016-16-011, GNT2008447, RP-2015-06-18, Office of Health and Medical Research, OHMR, Health Research Council of New Zealand, HRC: 16/631, Eisai, Ministère des Affaires Sociales et de la Santé: PHRC-20-0147, Université Pierre et Marie Curie, UPMC, NIHR Imperial Biomedical Research Centre, BRC, Minderoo Foundation, Funding/Support : The Platform for European Preparedness Against (Re-) emerging Epidemics (PREPARE) consortium by the European Union, FP7-HEALTH-2013-INNOVATION-1 (#602525), the Rapid European COVID-19 Emergency Research response (RECOVER) consortium by the European Union’s Horizon 2020 research and innovation programme (#101003589), the Australian National Health and Medical Research Council (#APP1101719), the Australian Medical Research Future Fund (#APP2002132), the Health Research Council of New Zealand (#16/631), the Canadian Institutes of Health Research Strategy for Patient-Oriented Research Innovative Clinical Trials Program Grant (#158584) and the Canadian Institute of Health Research COVID-19 Rapid Research Funding (#447335), the UK National Institute for Health Research (NIHR) and the NIHR Imperial Biomedical Research Centre, the Health Research Board of Ireland (CTN 2014-012), the UPMC Learning While Doing Program, the Translational Breast Cancer Research Consortium, the French Ministry of Health (PHRC-20-0147), the Wellcome Trust Innovations Project (215522), the Minderoo Foundation, the EU Programme Emergency Support Instrument, the NHS Blood and Transplant Research and Development Programme, the Translational Breast Cancer Research Consortium, the NSW Office of Health and Medical Research, Amgen, Eisai, and the Pittsburgh Foundation. Dr Higgins is funded by an NHMRC Emerging Leadership Fellowship (GNT2008447). Dr McQuilten is funded by an NHMRC Emerging Leadership Fellowship (APP194811). Dr Gordon is funded by an NIHR Research Professorship (RP-2015-06-18) and Dr Shankar-Hari by an NIHR Clinician Scientist Fellowship (CS-2016-16-011). Dr Turgeon is the Chairholder of the Canada Research Chair in Critical Care Neurology and Trauma. Dr Lawler is supported by a career award from the Heart and Stroke Foundation of Canada., and European Project: 602525,EC:FP7:HEALTH,FP7-HEALTH-2013-INNOVATION-1,PREPARE(2014)
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Adult ,Male ,corticosteroid ,[SDV]Life Sciences [q-bio] ,Critical Illness ,lnfectious Diseases and Global Health Radboud Institute for Molecular Life Sciences [Radboudumc 4] ,antiplatelet ,Lopinavir ,Adaptive platform trial randomized controlled trial intensive care, pneumonia COVID-19 antiplatelet immunoglobulin antiviral corticosteroid immune modulation anticoagulation ,All institutes and research themes of the Radboud University Medical Center ,Adrenal Cortex Hormones ,Humans ,anticoagulation ,intensive care, pneumonia ,COVID-19 Serotherapy ,Original Investigation ,Medicine(all) ,immune modulation ,Ritonavir ,SARS-CoV-2 ,COVID-19 ,Anticoagulants ,Bayes Theorem ,General Medicine ,Middle Aged ,antiviral ,Receptors, Interleukin-6 ,Adaptive platform trial ,randomized controlled trial ,Female ,Human medicine ,immunoglobulin ,Follow-Up Studies ,Hydroxychloroquine - Abstract
ImportanceThe longer-term effects of therapies for the treatment of critically ill patients with COVID-19 are unknown.ObjectiveTo determine the effect of multiple interventions for critically ill adults with COVID-19 on longer-term outcomes.Design, Setting, and ParticipantsPrespecified secondary analysis of an ongoing adaptive platform trial (REMAP-CAP) testing interventions within multiple therapeutic domains in which 4869 critically ill adult patients with COVID-19 were enrolled between March 9, 2020, and June 22, 2021, from 197 sites in 14 countries. The final 180-day follow-up was completed on March 2, 2022.InterventionsPatients were randomized to receive 1 or more interventions within 6 treatment domains: immune modulators (n = 2274), convalescent plasma (n = 2011), antiplatelet therapy (n = 1557), anticoagulation (n = 1033), antivirals (n = 726), and corticosteroids (n = 401).Main Outcomes and MeasuresThe main outcome was survival through day 180, analyzed using a bayesian piecewise exponential model. A hazard ratio (HR) less than 1 represented improved survival (superiority), while an HR greater than 1 represented worsened survival (harm); futility was represented by a relative improvement less than 20% in outcome, shown by an HR greater than 0.83.ResultsAmong 4869 randomized patients (mean age, 59.3 years; 1537 [32.1%] women), 4107 (84.3%) had known vital status and 2590 (63.1%) were alive at day 180. IL-6 receptor antagonists had a greater than 99.9% probability of improving 6-month survival (adjusted HR, 0.74 [95% credible interval {CrI}, 0.61-0.90]) and antiplatelet agents had a 95% probability of improving 6-month survival (adjusted HR, 0.85 [95% CrI, 0.71-1.03]) compared with the control, while the probability of trial-defined statistical futility (HR >0.83) was high for therapeutic anticoagulation (99.9%; HR, 1.13 [95% CrI, 0.93-1.42]), convalescent plasma (99.2%; HR, 0.99 [95% CrI, 0.86-1.14]), and lopinavir-ritonavir (96.6%; HR, 1.06 [95% CrI, 0.82-1.38]) and the probabilities of harm from hydroxychloroquine (96.9%; HR, 1.51 [95% CrI, 0.98-2.29]) and the combination of lopinavir-ritonavir and hydroxychloroquine (96.8%; HR, 1.61 [95% CrI, 0.97-2.67]) were high. The corticosteroid domain was stopped early prior to reaching a predefined statistical trigger; there was a 57.1% to 61.6% probability of improving 6-month survival across varying hydrocortisone dosing strategies.Conclusions and RelevanceAmong critically ill patients with COVID-19 randomized to receive 1 or more therapeutic interventions, treatment with an IL-6 receptor antagonist had a greater than 99.9% probability of improved 180-day mortality compared with patients randomized to the control, and treatment with an antiplatelet had a 95.0% probability of improved 180-day mortality compared with patients randomized to the control. Overall, when considered with previously reported short-term results, the findings indicate that initial in-hospital treatment effects were consistent for most therapies through 6 months.
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- 2023
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7. OA15.03 Avelumab vs Chemotherapy for First-line Treatment of Advanced PD-L1+ NSCLC: Primary Analysis from JAVELIN Lung 100
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Reck, M., primary, Barlesi, F., additional, Yang, J.C.-H., additional, Westeel, V., additional, Felip, E., additional, Özgüroğlu, M., additional, Dols, M. Cobo, additional, Sullivan, R., additional, Kowalski, D., additional, Andric, Z., additional, Lee, D.H., additional, Sezer, A., additional, Shamrai, V., additional, Szalai, Z., additional, Wang, X., additional, Xiong, H., additional, Jacob, N., additional, Mehr, K. Tadjalli, additional, and Park, K., additional
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- 2022
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8. Tumor Treating Fields (TTFields) Therapy with Standard of Care in Metastatic Non-small Cell Lung Cancer Following Progression on or after Platinum Therapy: Global, Randomized, Pivotal Phase 3 LUNAR Study
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Leal, T.A., Kotecha, R., Ramlau, R., Zhang, L., Milanowski, J., Cobo, M., Roubec, J., Petruzelka, L., Havel, L., Kalmadi, S., Ward, J., Andric, Z., Berghmans, T., Gerber, D.E., Kloecker, G., Panikkar, R., Aerts, J., Delmonte, A., Pless, M., and Langer, C.
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- 2024
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9. 565TiP A phase I/II dose-escalation and expansion study of ZN-c5, an oral selective estrogen receptor degrader (SERD), as monotherapy and in combination with palbociclib in patients with advanced estrogen receptor (ER)+/HER2- breast cancer
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Abramson, V., primary, Linden, H.M., additional, Crew, K., additional, Mortimer, J., additional, Alidzanovic, J., additional, Nangia, J., additional, Layman, R., additional, Vranjes, Z.J., additional, Andric, Z., additional, Milovic-Kovacevic, M., additional, Trifunovic, J., additional, Karchmit, Y., additional, Suarez, J., additional, Suster, M., additional, Ptaszynski, M., additional, and Chalasani, P., additional
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- 2021
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10. 1281O Atezolizumab (atezo) vs platinum-based chemo in blood-based tumour mutational burden-positive (bTMB+) patients (pts) with first-line (1L) advanced/metastatic (m)NSCLC: Results of the Blood First Assay Screening Trial (BFAST) phase III cohort C
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Dziadziuszko, R., primary, Peters, S., additional, Gadgeel, S.M., additional, Mathisen, M.S., additional, Shagan, S.M., additional, Felip, E., additional, Morabito, A., additional, Cheema, P., additional, Dols, M. Cobo, additional, Andric, Z., additional, Barrios, C.H., additional, Yamaguchi, M., additional, Dansin, E., additional, Danchaivijitr, P., additional, Johnson, M., additional, Novello, S., additional, Gandara, D.R., additional, Schleifman, E., additional, Wang, J., additional, and Mok, T.S.K., additional
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- 2021
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11. 1654P A phase Ib/II study of the dual MDMX/MDM2 inhibitor, ALRN-6924, for the prevention of chemotherapy-induced myelosuppression
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Andric, Z., primary, Ceric, T., additional, Rancic, M., additional, Jakopovic, M., additional, Ponce Aix, S., additional, Ramlau, R., additional, Ulanska, M., additional, Caldwell, C., additional, Ferrari, D., additional, Annis, A., additional, Vukovic, V., additional, and Zaric, B., additional
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- 2021
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12. High frequency of DQB1*05 and absolute absence of DRB1*13 in muscle-specific tyrosine kinase positive myasthenia gravis
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Nikolic, A. V., Andric, Z. P., Simonovic, R. B., Stojanovic, Rakocevic V.M., Basta, I. Z., Bojic, S. D., and Lavrnic, D. V.
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- 2015
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13. P-159 HERIZON: Phase 2 part of the IMU-131 HER2/neu vaccine plus chemotherapy study randomized in patients with HER2/NEU overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction
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Maglakelidze, M., primary, Ryspayenva, D., additional, Bulat, I., additional, Andric, Z., additional, Nikolic, I., additional, Chawla, T., additional, Choudhary, V., additional, Venkata, G., additional, Radosavljevic, D., additional, Petrovic, Z., additional, Wiedermann, U., additional, Chong, L., additional, Laeufle, R., additional, Ede, N., additional, Nixon, B., additional, and Good, A., additional
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- 2021
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14. Luminescence properties of SiO2:Eu3+ nanopowders: Multi-step nano-designing
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Jokanović, V., Dramićanin, M.D., Andrić, Ž., Jokanović, B., Nedić, Z., and Spasic, A.M.
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- 2008
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15. Nanostructure designed powders of optical active materials MexSiOy obtained by ultrasonic spray pyrolysis
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Jokanović, V., Dramićanin, M.D., Andrić, Ž., Dramićanin, T., Plavšić, M., Pašalić, S., and Miljković, M.
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- 2008
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16. Polymer complex solution synthesis of (YxGd1−x)2O3:Eu3+ nanopowders
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Andrić, Ž., Dramićanin, M.D., Mitrić, M., Jokanović, V., Bessière, A., and Viana, B.
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- 2008
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17. Synthesis of Y 2SiO 5:Eu 3+ nanoparticles from a hydrothermally prepared silica sol
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Dramićanin, M.D., Viana, B., Andrić, Ž., Djoković, V., and Luyt, A.S.
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- 2008
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18. FP13.03 IMpower110: Updated OS Analysis of Atezolizumab vs Platinum-Based Chemotherapy as First-Line Treatment in PD-L1–Selected NSCLC
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Herbst, R., primary, De Marinis, F., additional, Giaccone, G., additional, Vergnenegre, A., additional, Barrios, C., additional, Morise, M., additional, Felip, E., additional, Oprean, C., additional, Kim, Y., additional, Andric, Z., additional, Mocci, S., additional, Enquist, I., additional, Komatsubara, K., additional, Mccleland, M., additional, Deng, Y., additional, Kuriki, H., additional, Villalobos, M., additional, Phan, S., additional, Spigel, D., additional, and Jassem, J., additional
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- 2021
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19. PD-8 HERIZON: A phase 2 study of HER-Vaxx (IMU-131), a HER2-targeting peptide vaccine plus SOC chemotherapy in patients with HER2+ advanced stomach cancer – correlation of the antibody responses and clinical outcome
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Tobias, J., Kundi, M., Garner-Spitzer, E., Zielinski, C., Maglakelidze, M., Andric, Z., Petrovic, Z., Nagarkar, R., Chawla, T., Chong, L., Nixon, B., Yavrom, S., Ede, N., and Wiedermann, U.
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- 2023
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20. Luminescence and structural properties of Gd 2SiO 5:Eu 3+ nanophosphors synthesized from the hydrothermal obtained silica sol
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Dramićanin, M.D., Jokanović, V., Viana, B., Antic-Fidancev, E., Mitrić, M., and Andrić, Ž.
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- 2006
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21. Prevention of Chemotherapy-induced Myelosuppression in SCLC patients treated with the Dual MDMX/MDM2 Inhibitor ALRN-6924
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Andric, Z., primary, Ceric, T., additional, Stanetic, M., additional, Rancic, M., additional, Jakopovic, M., additional, Aix, S. Ponce, additional, Ramlau, R., additional, Smit, E., additional, Ulanska, M., additional, Caldwell, C., additional, Ferrari, D., additional, Annis, A., additional, Vukovic, V., additional, and Zaric, B., additional
- Published
- 2020
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- View/download PDF
22. LBA1 Clinical efficacy of atezolizumab (atezo) in biomarker subgroups by SP142, SP263 and 22C3 PD-L1 immunohistochemistry (IHC) assays and by blood tumour mutational burden (bTMB): Results from the IMpower110 study
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Herbst, R.S., primary, de Marinis, F., additional, Giaccone, G., additional, Reinmuth, N., additional, Vergnenegre, A., additional, Barrios, C.H., additional, Morise, M., additional, Felip, E., additional, Andric, Z., additional, Geater, S., additional, Ozguroglu, M., additional, Mocci, S., additional, McCleland, M., additional, Zou, W., additional, Enquist, I., additional, Komatsubara, K., additional, Deng, Y., additional, Kuriki, H., additional, Spigel, D.R., additional, and Jassem, J., additional
- Published
- 2019
- Full Text
- View/download PDF
23. Pneumologische Onkologie Tumor Treating Fields (TTFields) therapy with standard systemic therapy in metastatic non-small cell lung cancer following progression on or after platinum-based therapy: global randomized, pivotal (phase 3) LUNAR study.
- Author
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Weiss, L, Greil, R, Leal, T, Kotecha, R, Ramlau, R, Zhang, L, Milanowski, J, Cobo, M, Roubec, J, Petruzelka, L, Havel, L, Kalmadi, S, Ward, J, Andric, Z, Berghmans, T, Gerber, D, Kloecker, G, Panikkar, R, Aerts, J, and Delmonte, A
- Published
- 2024
- Full Text
- View/download PDF
24. Clinical activity of vofatamab, an FGFR3 selective antibody in combination with pembrolizumab in metastatic urothelial carcinoma (mUC), updated follow up results from the interim analysis of FIERCE-22
- Author
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Siefker-Radtke, A., primary, Lugowska, I., additional, Tupikowski, K., additional, Andric, Z., additional, Rezazadeh-Kalebasty, A., additional, Curigliano, G., additional, Vaena, D., additional, Vogl, F.D., additional, Currie, G., additional, Abella, E., additional, and Kelly, W., additional
- Published
- 2019
- Full Text
- View/download PDF
25. Relationship between distribution of LDL subfractions and NAFLD in PCOS - Effect on CV risk
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Blagojevic, I. Perovic, primary, Ignjatovic, S., additional, Macut, D., additional, Kotur-Stevuljevic, J., additional, Bozic-Antic, I., additional, Vekic, J., additional, Bjekic-Macut, J., additional, Kastratovic-Kotlica, B., additional, Andric, Z., additional, and Ilic, D., additional
- Published
- 2019
- Full Text
- View/download PDF
26. Cardiotoxicity: Importance of biomarkers
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Kostadinović Jelena, Popadić Višeslav, Klašnja Slobodan, Klisić Aleksandra, Kotur-Stevuljević Jelena, Andrić Zoran, and Zdravković Marija
- Subjects
cardiotoxicity biomarkers ,anthracyclines ,trastuzumab ,Pharmacy and materia medica ,RS1-441 - Abstract
The clinical efficacy of chemotherapy, as a recognized therapeutic approach for malignant diseases, usually has certain limitations due to its cardiotoxicity (CT) and consequent cardiomyopathy, or even heart failure. CT is defined as any cardiac injury connected with oncology treatment, whether it is chemo-, radio-, targeted or immunotherapy, or cancer by itself, and it represents a great challenge for clinicians in everyday practice. A wide spectrum of factors related to chemotherapy (type of drug, dose during each cycle, cumulative dose, schedule, method of application, combination with other cardiotoxic drugs or association with radiotherapy) and patient characteristics (age, presence of cardiovascular risk factors, previous cardiovascular disease) are the determining factors that influence the frequency of CT. Imaging methods for morphological and functional monitoring of the heart muscle are used for monitoring CT. The quest for diagnostic tools for early CT detection is of great significance. In line with this, the measurement of some cardiac biomarkers has found its place in clinical settings as an early determinant of myocardial injury. Therefore, in this review article, special attention will be paid to certain well-established, as well as certain novel cardiac biomarkers, and their role in recognizing asymptomatic CT, in order to gain deeper insight into their diagnostic utility.
- Published
- 2023
27. Phase III safety study of intravenous NEPA: a novel fixed antiemetic combination of fosnetupitant and palonosetron in patients receiving highly emetogenic chemotherapy
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Schwartzberg, L., primary, Roeland, E., additional, Andric, Z., additional, Kowalski, D., additional, Radic, J., additional, Voisin, D., additional, Rizzi, G., additional, Navari, R., additional, Gralla, R.J., additional, and Karthaus, M., additional
- Published
- 2018
- Full Text
- View/download PDF
28. Phase 3 safety evaluation of an intravenous formulation of NEPA, a novel fixed antiemetic combination of fosnetupitant and palonosetron
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Schwartzberg, L., primary, Andric, Z., additional, Kowalski, D., additional, Voisin, D., additional, Rizzi, G., additional, and Karthaus, M., additional
- Published
- 2017
- Full Text
- View/download PDF
29. O08 - Clinical activity of vofatamab, an FGFR3 selective antibody in combination with pembrolizumab in metastatic urothelial carcinoma (mUC), updated follow up results from the interim analysis of FIERCE-22
- Author
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Siefker-Radtke, A., Lugowska, I., Tupikowski, K., Andric, Z., Rezazadeh-Kalebasty, A., Curigliano, G., Vaena, D., Vogl, F.D., Currie, G., Abella, E., and Kelly, W.
- Published
- 2019
- Full Text
- View/download PDF
30. Human leukocyte antigen class II (DRB1 and DQB1) alleles and haplotypes frequencies in patients with pemphigus vulgaris among the Serbian population
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Zivanovic, D., primary, Bojic, S., additional, Medenica, L., additional, Andric, Z., additional, and Popadic, D., additional
- Published
- 2016
- Full Text
- View/download PDF
31. Erlotinib as First-Line Treatment for Patients with Advanced EGFR Mutation-Positive Non-Small-Cell Lung Cancer: Phase Iiib Study
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Zaric, B., primary, Perin, B., additional, Cekic, M., additional, Rancic, M., additional, Kovcin, V., additional, Andric, Z., additional, Murtezani, Z.H., additional, Jovanovic, D., additional, Velinovic, M., additional, and Markovic, M., additional
- Published
- 2015
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32. 1547PD - Phase 3 safety evaluation of an intravenous formulation of NEPA, a novel fixed antiemetic combination of fosnetupitant and palonosetron
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Schwartzberg, L., Andric, Z., Kowalski, D., Voisin, D., Rizzi, G., and Karthaus, M.
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- 2017
- Full Text
- View/download PDF
33. High frequency of DQB1*05 and absolute absence of DRB1*13 in muscle-specific tyrosine kinase positive myasthenia gravis
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Nikolic, A. V., primary, Andric, Z. P., additional, Simonovic, R. B., additional, Rakocevic Stojanovic, V. M., additional, Basta, I. Z., additional, Bojic, S. D., additional, and Lavrnic, D. V., additional
- Published
- 2014
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- View/download PDF
34. Assessment of age-related influences on the quality of life of breast cancer patients before and after surgical treatment
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Kostić Sanja, Murtezani Zafir, Andrić Zoran, Ivanović Nebojša, Kozomara Zoran, Kostić Marko, Miličić Vesna, and Kocić Sanja
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breast neoplasms ,quality of life ,age groups ,surgical procedures, operative ,surveys and questionnaires ,Medicine (General) ,R5-920 - Abstract
Background/Aim. Breast cancer comprises about 25% of all female cancers, and its incidence is increasing. New diagnostic procedures and therapeutic modalities have increased treatment success rates as well as patient survival. The goal of contemporary treatment is not only patient survival, but also a better quality of life (QoL). The objective of this study was to assess the effect of age at diagnosis on the QoL of patients with breast cancer before and after surgery. Methods. We analyzed QoL in 170 female patients (43 patients < 50 and 127 patients ≥ 50 years) diagnosed with breast cancer (I and II stage) a month before and after surgical treatment, using the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) questionnaire and specific version for breast cancer patients (EORTC QLQ-BR23). Results. The QLQ-C30 questionnaire showed that surgical treatment significantly decreased all domains of the patients’ QoL in both age groups. Agerelated differences were present in sexual functioning and pleasure independently of surgical treatment, with higher scores in the group of younger women. The analysis of data obtained using the QLQ-BR23 questionnaire revealed a lower QoL after surgical treatment in almost all dimensions regardless of patients’ age. Conclusion. The results of our study pointed out statistically significant differences in the QoL domains of sexual functioning, and sexual enjoyment between women in both age groups independently of surgical treatment. The QoL was better in the younger age group. Surgical breast cancer treatment negatively affected patients QoL independently of age.
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- 2020
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- View/download PDF
35. Long-term antibody-response monitoring following primary exposure to SARS-COV-2 and afterward mRNA COVID-19 vaccination: A case report
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Balint Bela, Todorović Milena, Andrić Zorana, Jovičić Milica, Blagojević Glorija, and Čolić Miodrag
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antibodies ,covid-19 ,covid-19 serotherapy ,infections ,vaccination ,Medicine (General) ,R5-920 - Abstract
nema
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- 2021
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- View/download PDF
36. Evaluation of a summary score for dyslipidemia, oxidative stress and inflammation (the DOI score) in women with polycystic ovary syndrome and its relationship with obesity
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Perović-Blagojević Iva, Ignjatović Svetlana, Macut Đuro, Kotur-Stevuljević Jelena, Božić-Antić Ivana, Vekić Jelena, Bjekić-Macut Jelica, Kastratović-Kotlica Biljana, Andrić Zoran, and Ilić Dušan
- Subjects
polycystic ovary syndrome ,dyslipidemia ,oxidative stress ,inflammation ,doi score ,obesity ,Biochemistry ,QD415-436 - Abstract
Background: Polycystic ovary syndrome (PCOS) is a cardiometabolic disorder whose features include dyslipidemia, increased oxidative stress (OS, oxy) and chronic inflammation. The aim of this study was to investigate the ability of a summary score for dyslipidemia, OS and inflammation (the DOI score) to discriminate PCOS patients from healthy individuals and to evaluate the effect of obesity on individual scores and the DOI score in patients. Methods: Lipid status parameters, OS status parameters (advanced oxidation protein products; total oxidative status; prooxidant-antioxidant balance; malondialdehyde; total protein sulphydryl groups and paraoxonase 1 activity) and CRP were measured in 114 patients and 50 controls using standardised assays. The DOI score was calculated as the sum of dyslipidemia, oxy and inflammation scores, determined as Z-score values for every subject in relation to the controls. Results: PCOS patients had significantly higher oxy-score compared to controls (P0.9, P
- Published
- 2018
37. Cortisol response to low-dose (1 ug) ACTH stimulation for the prediction of outcome in patients with systemic inflammatory response syndrome
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Bjekić-Macut Jelica, Radosavljević Vojislav, Andrić Zoran, Ilić Dušan, Stanojlović Olivera, Vojnović-Milutinović Danijela, Božić-Antić Ivana, Zdravković Marija, Hinić Saša, Macut Đuro, and Zarković Miloš
- Subjects
cortisol ,systemic inflammatory response syndrome ,acth test ,apache ii ,sofa ,Biochemistry ,QD415-436 - Abstract
Background: Systemic inflammatory response syndrome (SIRS) changes cortisol dynamics and indicates dissociation between the adrenal cortex and the hypothalamo-pituitary unit. The aim of this study was to assess the cortisol response after stimulation with ACTH1-24 in patients with SIRS at admission to the Respiratory Intensive Care Unit (RICU) and seven days later. Methods: Fifty-four subjects were included in the study, and SIRS was defined according to the Consensus Conference criteria from 1992. Severity of the disease was determined using the APACHE II score, and organ dysfunction using the SOFA score. Low-dose (1 mg) ACTH test (LDT) was performed in all patients, and cortisol was determined along with basal ACTH. Data were analyzed using parametric and nonparametric tests and regression analysis. The results are presented as mean ± standard deviation, and P< 0.05 was considered statistically significant. Results: There were no differences in cortisol values between the two LDTs. Cortisol increment lower than 250 nmol/L during the LDT was found in 14/54 (25.9%) subjects at the onset of SIRS. Five out of 54 (9.6%) patients died within 7 days from the onset of SIRS. Female sex and maximal cortisol response (D max) on LDT predicted the duration of hospitalization in RICU, while APACHE II and SOFA scores best predicted the duration of hospitalization, mortality outcome as well as overall survival outcome. Conclusions: A difference was found in D max at the diagnosis of SIRS and seven days later. D max, and primarily the clinical scores APACHE II and SOFA predicted the outcomes of hospitalization and overall survival.
- Published
- 2016
38. Changes of cognitive functions after stroke
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Gašparić, I., Andrić, Z., and Gotovac, N.
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- 2009
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39. 96LBA Late Breaking - Prevention of Chemotherapy-induced Myelosuppression in SCLC patients treated with the Dual MDMX/MDM2 Inhibitor ALRN-6924.
- Author
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Andric, Z., Ceric, T., Stanetic, M., Rancic, M., Jakopovic, M., Aix, S. Ponce, Ramlau, R., Smit, E., Ulanska, M., Caldwell, C., Ferrari, D., Annis, A., Vukovic, V., and Zaric, B.
- Subjects
- *
ANTINEOPLASTIC agents , *BONE marrow , *CONFERENCES & conventions , *DRUG toxicity , *PROTEINS , *SMALL cell carcinoma , *CHEMICAL inhibitors - Published
- 2020
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- View/download PDF
40. Evaluation of the efficacy and toxicity of protocol cisplatin, 5-fluorouracil, leucovorin compared to protocol fluorouracil, doxorubicin and mitomycin C in locally advanced and metastatic gastric cancer
- Author
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Andrić Zoran, Ranđelović Tomislav, Kovčin Vladimir, Gutović Jasmina, Crevar Slobodanka, Murtezani Zafir, and Kostić Sanja
- Subjects
gastric cancer ,chemotherapy ,combination ,treatment efficacy ,drug toxicity ,Medicine - Abstract
Introduction. Still there is no consensus on the choice of the most efficient and the least toxic chemotherapy regimen in the treatment of advanced gastric cancer. Nowadays few therapy protocols are available for treating this disease. Objective. Study was conducted to compare the efficacy and toxicity of FAM (flurouracil, doxorubicin, mitomycin C) with CDDP and FU/FA (cisplatin, 5-fluorouracil, leucovorin) protocols in patients with locally advanced and metastatic gastric cancer. Methods. This randomized study involved a group of 50 patients with locally advanced or metastatic gastric cancer, who had not previously undergone chemotherapy treatment. Progression free survival, overall survival and drug toxicity were evaluated. For statistical analysis chi-square test, Kaplan-Meier curve and the log rank test were used. Results. The overall response rate was 20% in the group treated with FAM and 24% in the group treated with CDDP, FU/FA (4% of patients from each group had complete response), but without significant statistical difference. Median survival was 10.9 months in the FAM group and 11.8 months in CDDP, FU/FA group, with no statistically significant difference. Non-haematological and haematological toxicities of CDDP, FU/FA were considerably less frequent than of FAM, and there was no treatment related deaths in any of the groups. Conclusion. Both investigated regimens demonstrated moderate efficacy. The study shows in favour of justified application of both protocols, while in regard to toxicity CDDP and FU/FA can be recommended as preferable treatment for locally advanced and metastatic gastric cancer. New strategies should be considered for better efficacy in the treatment of advanced gastric cancer. New strategies are necessary with the goal to achieve a better therapeutic effect.
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- 2012
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41. Efficacy and safety of bevacizumab in combination with oxaliplatin, irinotecan and fluoropyrimidine-based therapy in advanced colorectal cancer
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Popov Ivan, Tarabar Dino, Jovanović Dušan, Kovčin Vladimir, Radić Stojan, Micev Marjan, Petrović Zoran, Manojlović Nebojša, Andrić Zoran, Dagović Aleksandar, Kukić Biljana, Radoševic-Jelić Ljiljana, Kecmanović Dragutin, Josifovski Jeremija, and Jezdić Svetla
- Subjects
antibodies ,monoclonal ,angiogensis inhibitors ,colorectal neoplasms ,treatment outcome ,antineoplastic combined chemotherapy protocols ,vascular endothelial growth factor A + antagonists and inhibitors ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Background: Bevacizumab is an anti-VEGF, humanized mAb that is the most advanced agent of its class in clinical development. Several studies have examined bevacizumab in combination with chemotherapy in the first- and second-line settings in patients with metastatic CRC. Despite of that, there is lack of information concerning the extent to which bevacizumab can be used to treat metastatic CRC. We still need more evidence related to efficacy and safety of bevacizumab in different settings, or sequential treatments. The aim of this study was to investigate efficacy and safety of bevacizumab added to different chemotherapy in patients with metastatic CRC. Methods: This was a controlled, prospective, multicentre, cohort study. Thirty patients with advanced colorectal cancer were enrolled into this study. Bevacizumab was applied with oxaliplatin-, irinotecan-, 5FU- or capecitabine -based chemotherapy in the first-, second- or third-therapy lines. Totally 261 cycles were applied. The median number of applied cycles per patient was 8 (range 2-16). Results: Objective tumor response (RR) was seen in 11 patients 37% (95%CI 19-69%) calculated on an intention-to-treat basis. The median duration of response was 12 months. Three of 11 patients (27%) with PR had secondary surgery. RR was seen in 9 of 16 patients (56%) who received bevacizumab in the first-line treatment and in 2 of 14 patients (14%) who received therapy in the second+ lines (p=0.02). Clinical benefit (PR+SD) was seen in 22 (74%) patients. 75% of patients achieved clinical benefit in the first-line and 74% in the second+ chemotherapy lines. The median time to progression (TTP) of the patients is was 9 + months (95%CI 7 - + ∞) at the moment of this analysis. The median TTP of patients who received bevacizumab in the first line was 11 months (95%CI 8 - + ∞). The median TTP of patients who received bevacizumab in the second+ lines was 5.5 months (95%CI 4 - + ∞) (p=0.015). The median survival time (OS) for all patients was 9 + months (95%CI 7 - + ∞). The median OS at the moment of analysis was 11 months (95%CI 9 - + ∞) for patients receiving bevacizumab in the first line, and 7 months for patients receiving the drug in the second+ lines (95%CI 6 - + ∞) (p=0.024). The incidence of any toxicity grade 3-4 was less than 10%. Bevacizumab associated incidence of grade 3-4 side effects did not exceed 5%. Hypertension 5% and thromboembolism 5% were the most frequent events. Gastrointestinal perforation did not occur. There was one toxic death due to sepsis and not directly associated with bevacizumab toxicity. Conclusion: Bevacizumab can safely be added to different chemotherapeutic regimens in first- and second+ line. The conferred benefit in overall survival, TTP and response rate obviously requires randomized trials.
- Published
- 2007
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42. Magnetic properties of nanostructured SiOo2:Eu3+ powders
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Spasojević Vojislav, Dramićanin Miroslav, Jokanović Vukoman, Andrić Željka, Blanuša Jovan, Kusigerski Vladan, Mitrić Miodrag, Tadić Marin, and Kapičić Ana
- Subjects
magnetic properties ,nanoparticles ,rare earth ,silica ,light scattering ,Chemistry ,QD1-999 - Abstract
Eu-doped silica nanoparticles with different concentrations of europium (3% 6%and 15at.%) were prepared by a hydrothermal procedure. Light scattering measurements of the silica colloids as well as TEM microscopy, revealed a narrow size distribution of the particles, ranging from 5 to 10 nm. X-Ray diffraction showed that all the powders were amorphous. Magnetic susceptibility vs. temperature measurements showed a behavior typical for Eu3+ ions, with a plateau below 60K, and an increase of the mass susceptibility with Eu concentration. The splitting of zero-field cooled (ZFC) and field-coled (FC) susceptibility branches increased with the europium concentration, indicating the presence of interparticle interactions. At temperatures below 40K, a contribution of paramagnetic impurities obeying the Curie law was observed. Heat treatment of the powders at 823K and 1073K increased the magnetic susceptibility. The appearance of a small peak at 70K indicated the presence of small quantities of ferromagnetic EuO in the powders after heating.
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- 2006
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43. Xeloda as first-line therapy of metastatic colorectal cancer-our experience
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Kovčin Vladimir, Ješić Rada, Krivokapić Zoran V., Andrić Zoran, and Pavlović Aleksandra
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Colorectal neoplasms ,antimetabolites ,antineoplastic ,combined chemotherapy protocols ,neoplasm metastasis ,treatment outcome ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
BACKGROUND: Results of phase III clinical studies comparing efficacy of Xeloda vs. standard 5-FU/FA protocols as first line therapy of metastatic colorectal carcinoma (MCRC), have shown better efficacy of Xeloda, with less toxic adverse effects, apart from handfoot syndrome. METHODS: From January 2000 to May 2001 the study enrolled 54 patients with MCRC, 38 males and 16 females, aged 30-78 years. All patients had metastatic diseases. In 33 the primary tumor was in colon, in 21 in rectum. All patients received Xeloda 2500 mg/m2/day in two daily doses, during 14 days followed by 7 days of pause. Dose intensity was 88,79% +/- 9,2. For efficacy evaluation the WHO criteria and tumor markers CEA and CA 19-9 were used. RESULTS: Overall response rate was 47%, with 13% complete responses, 34% partial responses 38% stable disease and 15% disease progression. No significant difference was found between patients with regard to localization of primary tumor (colon or rectum). There was no significant difference in response rate when compared 27 patients with adverse events of capecitabine ('hand and foot' syndrome and diarrhea) and those without them. Response rate in a subgroup of 21 evaluable (out of 29) patients with initial signs of liver dysfunction was worse (p
- Published
- 2002
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44. 538PLung cancer vaccine: Experiences in Serbia.
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Andric, Z G
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CANCER vaccines , *PULMONOLOGY , *URBAN hospitals - Published
- 2018
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45. Capecitabine in the treatment of metastatic colorectal cancer in elderly patients
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Andrić Zoran, Gutović Jasmina, Murtezani Zafir, Milićević Nataša, and Kostić Sanja
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breast neoplasms ,prognosis ,aged ,women ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Published
- 2002
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46. Avelumab in Combination With Cetuximab and Chemotherapy as First-Line Treatment for Patients With Advanced Squamous NSCLC
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Zoran Andric, Gabriella Gálffy, Manuel Cobo Dols, Barna Szima, Goran Stojanovic, Marina Petrovic, Enriqueta Felip, David Vicente Baz, Santiago Ponce Aix, Oscar Juan-Vidal, Zsuzsanna Szalai, Gyorgy Losonczy, Antonio Calles Blanco, Reyes Bernabe, Gema García Ledo, Andrés Aguilar Hernández, Klaus Duecker, Dongli Zhou, Andreas Schroeder, Guelseren Guezel, Fortunato Ciardiello, Institut Català de la Salut, [Andric Z] Department of Medical Oncology, Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia. [Gálffy G] Pulmonology Hospital Törökbálint, Törökbálint, Hungary. [Cobo Dols M] Department of Medical Oncology, Hospital Regional Universitario de Málaga, Institute of Biomedical Research of Málaga (IBIMA), Málaga, Spain. [Szima B] Department of Pulmonology, Markusovszky Hospital, Szombathely, Hungary. [Stojanovic G] Institute of Pulmonary Diseases of Vojvodina, Sremska Kamenica, Serbia. [Petrovic M] Clinic for Pulmonology, Clinical Center Kragujevac, Kragujevac, Serbia. [Felip E] Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d'Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus
- Subjects
Pulmonary and Respiratory Medicine ,Otros calificadores::/uso terapéutico [Otros calificadores] ,terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] ,diagnóstico::pronóstico::resultado del tratamiento [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms::Bronchial Neoplasms::Carcinoma, Bronchogenic::Carcinoma, Non-Small-Cell Lung [DISEASES] ,neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pulmonares::neoplasias de los bronquios::carcinoma broncogénico::carcinoma de pulmón de células no pequeñas [ENFERMEDADES] ,Other subheadings::Other subheadings::/drug therapy [Other subheadings] ,Diagnosis::Prognosis::Treatment Outcome [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,Quimioteràpia combinada ,Oncology ,Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,Avaluació de resultats (Assistència sanitària) ,Other subheadings::/therapeutic use [Other subheadings] ,Pulmons - Càncer - Tractament - Abstract
Avelumab; Cetuximab; Non–small cell lung cancer Avelumab; Cetuximab; Càncer de pulmó de cèl·lules no petites Avelumab; Cetuximab; Cáncer de pulmón de células no pequeñas Introduction We present the results of a phase 2a trial of first-line avelumab (anti–programmed death-ligand 1 antibody) plus cetuximab (anti–EGFR antibody) in patients with advanced squamous NSCLC. Methods Patients with recurrent or metastatic squamous NSCLC received avelumab 800 mg (d 1 and 8), cetuximab 250 mg/m2 (d 1) and 500 mg/m2 (d 8), cisplatin 75 mg/m2 (d 1), and gemcitabine 1250 mg/m2 (d 1 and 8) for four 3-week cycles, followed by avelumab 800 mg and cetuximab 500 mg/m2 every 2 weeks. The primary end point was the best overall response; the secondary end points were progression-free survival, duration of response, overall survival, and safety. Efficacy analyses were reported from an updated data cutoff. Results A total of 43 patients were enrolled. The median follow-up was 6.6 months for the primary analyses and 9.2 months for the efficacy analyses. In the efficacy analyses, 15 patients had a confirmed partial response (objective response rate, 34.9% [95% confidence interval: 21.0%–50.9%]), and the median duration of response was 7.1 months (95% confidence interval: 4.2–12.5 mo). The median progression-free survival and overall survival were 6.1 months and 10.0 months, respectively. In the safety analyses (primary analysis), 38 patients (88.4%) had a treatment-related adverse event, of whom 24 (55.8%) had a grade 3 or higher treatment-related adverse event. Conclusions The combination of avelumab + cetuximab and chemotherapy showed antitumor activity and tolerable safety; however, the ORR was not improved compared with those reported for current standards of care (NCT03717155). This study was sponsored by the healthcare business of Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945) as part of an alliance between the healthcare business of Merck KGaA, Darmstadt, Germany, and Pfizer. Employees of the sponsor are coauthors of this manuscript and contributed to the design, execution, interpretation of the analyses, writing the report, and the decision to submit the article for publication, along with other coauthors. We thank the patients and their families, the investigators, co-investigators, and study teams at each participating center and the healthcare business of Merck KGaA, Darmstadt, Germany. Medical writing support was provided by Abhijith Thippeswamy of ClinicalThinking and funded by the healthcare business of Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945) and Pfizer.
- Published
- 2023
47. Alectinib versus Crizotinib in Untreated ALK-Positive Non–Small-Cell Lung Cancer
- Author
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Rafael Rosell, Alice T. Shaw, Ali Zeaiter, Shirish M. Gadgeel, Emmanuel Mitry, Bogdana Balas, Jin S. Ahn, Maurice Perol, Johannes Noe, Sai-Hong Ignatius Ou, Peter N. Morcos, D. Ross Camidge, Solange Peters, Tony Mok, Dong Wan Kim, Rafal Dziadziuszko, Sophie Golding, ALEX Trial Investigators, Nordman, I., Pittman, K., Dear, R., Lwin, Z., Briggs, P., Pavlakis, N., Ceric, T., Mehic, B., Stanetic, M., Franke, F.A., Castro, G., Santo Borges, G., Pereira, J., Brust, L., Santos, L., Cruz, M., Ribeiro, R., De Azevedo, S., Neron, Y.V., Sangha, R., Cohen, V., Burkes, R., Abdelsalam, M., Yadav, S., Cheema, P., Yanez, E., Aren, O., Zhou, C., Zhang, L., Liu, X., Corrales Rodriguez, L., Meldgaard, P., Soerensen, J.B., McCulloch, T., Rodriguez, N., Gaafar, R., Abdel Azeem, H., Coudert, B., Moro-Sibilot, D., Lena, H., Bennouna, J., Cortot, A., Veillon, R., Cadranel, J., Barlesi, F., Reck, M., Mezger, J., von Pawel, J., Fischer, J.R., Dickgreber, N.K., Zarogoulidis, K., Syrigos, K., Georgoulias, V., Agelaki, S., Castro-Salguero, H., Ho, J., Chan, S.H., Cheng, C.K., Ng, A., Stemmer, S., Wollner, M., Gottfried, M., Dudnik, J., Cyjon, A., Heching, N., Novello, S., Tiseo, M., Platania, M., Misino, A., Gridelli, C., Ciardiello, F., Favaretto, A., De Marinis, F., Longo, F., Bordonaro, R., Dazzi, C., Chiari, R., Mercuri, E., Macedo, E., Rodriguez Cid, J.R., McKeage, M., Vera, L., Morón Escobar, H.D., Rodriguez, M., Mas, L., Ramlau, R., Kowalski, D., Szczesna, A., Kazarnowicz, A., Milanowski, J., Luboch-Kowal, J., Oliveira, J., Barata, F., Almodovar, T., Lee, J.S., Cho, B.C., Kim, S.W., Han, J.Y., Karaseva, N., Stroyakovskii, D., Kuzmin, A., Smolin, A., Laktionov, K., Ragulin, Y., Filippov, A., Levchenko, E., Jovanovic, D., Perin, B., Andric, Z., Soo, R., Tan, E.H., De Castro Carpeno, J., Provencio Pulla, M., Garrido Lopez, P., Felip Font, E., Morano Bueno, T., Sanchez, A., Isla Casado, D., Ponce Aix, S., Reguart Aransay, N., Viteri Ramirez, S., Rodriguez Abreu, D., Sanchez Torres, J.M., Massuti Sureda, B., Ramos Vazquez, M., Tabernero, J.M., Curioni, A., Rothschild, S., Scherz, A., Chiu, C.H., Su, W.C., Yang, CHJ, Chang, G.C., Hsia, T.C., Yang, C.T., Tharavichitkul, E., Pongthai, P., Arpornwirat, W., Geater, S., Srimuninnimit, V., Sriuranpong, V., Demirkazik, A., Goker, E., Harputluoglu, H., Cicin, I., Kose, F., Erman, M., Bondarenko, I., Vinnyk, Y., Shparyk, Y., Golovko, Y., Lal, R., Forster, M., Califano, R., Skailes, G., Thompson, J., Mekhail, T., Polikoff, J., Spigel, D., Waqar, S., Hermann, R., Deo, E., Simon, G., Rybkin, I., Kaywin, P.R., Uyeki, J., Gubens, M., Limaye, S., Gerber, D.E., Leal, T., Spira, A.I., Bazhenova, L., Cetnar, J., Socinski, M., Jahanzeb, M., Kabbinavar, F., Lawler, W.E., Hancock, M.R., Raez, L.E., DiCarlo, B.A., Lowe, T.E., Fidler, M., Ross, H., Davidson, S.J., Sanchez, J.D., Hamm, J., Kerr, S., Belman, N., Baker, S., Naraev, B., Jung, G., Edelman, M., Feldman, L., Belani, C., and Pakkala, S.
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Adult ,Male ,0301 basic medicine ,Oncology ,Alectinib ,medicine.medical_specialty ,Pathology ,Lung Neoplasms ,Brigatinib ,Pyridines ,medicine.drug_class ,Carbazoles ,Antineoplastic Agents ,Kaplan-Meier Estimate ,Aged, 80 and over ,Animals ,Antineoplastic Agents/adverse effects ,Antineoplastic Agents/therapeutic use ,Carbazoles/adverse effects ,Carbazoles/therapeutic use ,Carcinoma, Non-Small-Cell Lung/drug therapy ,Carcinoma, Non-Small-Cell Lung/mortality ,Central Nervous System Neoplasms/drug therapy ,Central Nervous System Neoplasms/secondary ,Disease-Free Survival ,Female ,Follow-Up Studies ,Humans ,Intention to Treat Analysis ,Lung Neoplasms/drug therapy ,Lung Neoplasms/mortality ,Middle Aged ,Piperidines/adverse effects ,Piperidines/therapeutic use ,Protein Kinase Inhibitors/adverse effects ,Protein Kinase Inhibitors/therapeutic use ,Pyrazoles/adverse effects ,Pyrazoles/therapeutic use ,Pyridines/adverse effects ,Pyridines/therapeutic use ,Receptor Protein-Tyrosine Kinases/analysis ,Receptor Protein-Tyrosine Kinases/antagonists & inhibitors ,Young Adult ,Central Nervous System Neoplasms ,03 medical and health sciences ,0302 clinical medicine ,Piperidines ,Carcinoma, Non-Small-Cell Lung ,hemic and lymphatic diseases ,Internal medicine ,medicine ,Anaplastic lymphoma kinase ,Lung cancer ,Protein Kinase Inhibitors ,Crizotinib ,Ceritinib ,business.industry ,Receptor Protein-Tyrosine Kinases ,General Medicine ,medicine.disease ,Lorlatinib ,ALK inhibitor ,030104 developmental biology ,030220 oncology & carcinogenesis ,Pyrazoles ,business ,medicine.drug - Abstract
Alectinib, a highly selective inhibitor of anaplastic lymphoma kinase (ALK), has shown systemic and central nervous system (CNS) efficacy in the treatment of ALK-positive non-small-cell lung cancer (NSCLC). We investigated alectinib as compared with crizotinib in patients with previously untreated, advanced ALK-positive NSCLC, including those with asymptomatic CNS disease. In a randomized, open-label, phase 3 trial, we randomly assigned 303 patients with previously untreated, advanced ALK-positive NSCLC to receive either alectinib (600 mg twice daily) or crizotinib (250 mg twice daily). The primary end point was investigator-assessed progression-free survival. Secondary end points were independent review committee-assessed progression-free survival, time to CNS progression, objective response rate, and overall survival. During a median follow-up of 17.6 months (crizotinib) and 18.6 months (alectinib), an event of disease progression or death occurred in 62 of 152 patients (41%) in the alectinib group and 102 of 151 patients (68%) in the crizotinib group. The rate of investigator-assessed progression-free survival was significantly higher with alectinib than with crizotinib (12-month event-free survival rate, 68.4% [95% confidence interval (CI), 61.0 to 75.9] with alectinib vs. 48.7% [95% CI, 40.4 to 56.9] with crizotinib; hazard ratio for disease progression or death, 0.47 [95% CI, 0.34 to 0.65]; P
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- 2017
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48. Five-year survival in patients with extensive-stage small cell lung cancer treated with atezolizumab in the Phase III IMpower133 study and the Phase III IMbrella A extension study.
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Reck M, Dziadziuszko R, Sugawara S, Kao S, Hochmair M, Huemer F, de Castro G Jr, Havel L, Bernabé Caro R, Losonczy G, Lee JS, Kowalski DM, Andric Z, Califano R, Veatch A, Gerstner G, Batus M, Morris S, Kaul M, Cuchelkar V, Li H, Danner BJ, Nabet BY, and Liu SV
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- Humans, Male, Female, Middle Aged, Aged, Neoplasm Staging, Etoposide administration & dosage, Etoposide therapeutic use, Follow-Up Studies, Survival Rate, Adult, Aged, 80 and over, Antibodies, Monoclonal, Humanized therapeutic use, Antibodies, Monoclonal, Humanized administration & dosage, Antibodies, Monoclonal, Humanized adverse effects, Small Cell Lung Carcinoma drug therapy, Small Cell Lung Carcinoma mortality, Small Cell Lung Carcinoma pathology, Lung Neoplasms drug therapy, Lung Neoplasms mortality, Lung Neoplasms pathology, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antineoplastic Combined Chemotherapy Protocols adverse effects, Carboplatin administration & dosage, Carboplatin therapeutic use
- Abstract
Objectives: IMbrella A is a Phase III extension study that allowed rollover from Roche/Genentech-sponsored atezolizumab trials, including IMpower133, a Phase I/III trial of first-line atezolizumab or placebo plus carboplatin/etoposide in extensive-stage small cell lung cancer. We report outcomes from an exploratory analysis of IMpower133 with extended time-to-event data for patients who rolled over to IMbrella A., Materials and Methods: IMpower133 patients could roll over to IMbrella A to receive atezolizumab 1200 mg intravenously every three weeks if they continued to receive atezolizumab at IMpower133 closure or were in survival follow-up after atezolizumab discontinuation. Overall survival and safety were assessed; only serious adverse events and AEs of special interest were collected in IMbrella A., Results: Eighteen of 26 eligible patients rolled over to IMbrella A. At clinical cutoff (March 16, 2023), median follow-up in the atezolizumab plus carboplatin/etoposide arm (IMpower133 and IMbrella A) was 59.4 months. The three-, four-, and five-year overall survival (95 % CI) estimates were 16 % (11 %-21 %), 13 % (8 %-18 %), and 12 % (7 %-17 %), respectively. In IMbrella A, serious adverse events occurred in three patients (16.7 %), and one adverse event of special interest was reported (grade two hypothyroidism)., Conclusion: This long-term analysis of patients from IMbrella A previously enrolled in IMpower133 provides the first report of five-year overall survival outcomes in patients with extensive-stage small cell lung cancer treated with first-line cancer immunotherapy and chemotherapy. While limited by small patient numbers and lack of long-term data for the IMpower133 control arm, exploratory overall survival analyses in patients treated with atezolizumab plus carboplatin/etoposide compared favorably with historical data with chemotherapy alone. NCT03148418., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: All authors report editorial support funded by the Sponsor. Martin Reck reports receiving consulting fees, honoraria and travel support from Amgen, AstraZeneca, Beigene, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, GSK, Mirati, Merck, MSD, Lily, Novartis, Pfizer, Sanofi, Roche, and Regeneron; and participation on a data safety monitoring or advisory board for Sanofi and Daiichi Sankyo. Rafal Dziadziuszko reports receiving honoraria from Roche, AstraZeneca, Amgen, Novartis, MSD, Bristol Myers Squibb, Takeda, and Pfizer; and materials from Novartis. Shunichi Sugawara reports receiving grants (to institution) from AstraZeneca, Chugai Pharma, MSD, Bristol Myers Squibb, and Ono Pharmaceutical; and honoraria from AstraZeneca, Chugai Pharma, MSD, Bristol Myers Squibb, and Ono Pharmaceutical. Steven Kao reports receiving grants (to institution) from AstraZeneca; honoraria from AstaZeneca, Pfizer, MSD, Bristol Myers Squibb, Roche, Amgen, Beigene, and Boehringer Ingelheim; and travel support from MSD. Maximilian Hochmair reports receiving honoraria from MSD, Roche, Lilly, AstraZeneca, Takeda, Bristol Myers Squibb, and Amgen. Florian Huemer declares no conflict of interest. Gilberto de Castro, Jr reports receiving consulting fees from Daiichi-Sankyo; honoraria from AstraZeneca, Bristol Myers Squibb, Jannsen, Lilly, MSD, Novartis, Roche, Amgen, and Daiichi-Sankyo; travel support from Roche, Amgen, Daiichi-Sankyo, MSD, AstraZeneca, and Bristol Myers Squibb; and participation on a data safety monitoring or advisory board for GlaxoSmithKline, AstraZeneca, MSD, and Novartis. Libor Havel declares no conflict of interest. Reyes Bernabé Caro reports receiving an investigational grant from Roche; honoraria from Roche, Bristol Myers Squibb, Pfizer, MSD, Amgen, Takeda, and AstraZeneca; and participation in a data safety monitoring or advisory board for Takeda, Roche, Bristol Myers Squibb, and AstraZeneca. György Losonczy and Jong-Seok Lee declare no conflict of interest. Dariusz M. Kowalski reports participation on an advisory board and consultancy for Roche, Boehringer Ingelheim, Novartis, Bristol Myers Squibb, MSD, Sanofi-Aventis, Takeda, Pfizer, and Johnson & Johnson. Zoran Andric declares no conflict of interest. Raffaele Califano reports receiving grants (to institution) from Roche and MSD; consulting fees from Roche, MSD, Bristol Myers Squibb, and AstraZeneca; and honoraria from Roche, MSD, and AstraZeneca; membership in the EORTC lung cancer group and ESMO educational publication working group; and stock or stock options in The Christie Private Care and Supportive Care UK. Andrea Veatch, Gregory Gerstner, and Marta Batus declare no conflicts of interest. Stefanie Morris reports employment with and stock or stock options in Roche. Monika Kaul, Vaikunth Cuchelkar, Huafei Li, Bradford J. Danner, and Barzin Y. Nabet report employment with Roche. Stephen V. Liu reports receiving grants from AbbVie, Alkermes, Elevation Oncology, Ellipses, Genentech, Gilead, Merck, Merus, Nuvalent, RAPT, and Turning Point Therapeutics; and consulting fees from AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Catalyst, Daiichi Sankyo, Eisai, Elevation Oncology, Genentech/Roche, Gilead, Guardant Health, Janssen, Jazz Pharmaceuticals, Merck, Merus, Mirati, Novartis, Pfizer, Regeneron, Sanofi, Takeda, and Turning Point Therapeutics; and participation on a data safety monitoring for Candel Therapeutics., (Copyright © 2024. Published by Elsevier B.V.)
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- 2024
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49. Avelumab Versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients With High-Expression Programmed Death-Ligand 1-Positive Metastatic NSCLC: Primary Analysis From the Phase 3 JAVELIN Lung 100 Trial.
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Reck M, Barlesi F, Yang JC, Westeel V, Felip E, Özgüroğlu M, Dols MC, Sullivan R, Kowalski DM, Andric Z, Lee DH, Sezer A, Hu P, Wang X, von Heydebreck A, Jacob N, Mehr KT, and Park K
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- Adult, Humans, Antibodies, Monoclonal pharmacology, Antibodies, Monoclonal therapeutic use, Antineoplastic Combined Chemotherapy Protocols pharmacology, Antineoplastic Combined Chemotherapy Protocols therapeutic use, B7-H1 Antigen therapeutic use, Ligands, Lung pathology, Antibodies, Monoclonal, Humanized, Carcinoma, Non-Small-Cell Lung pathology, Lung Neoplasms pathology
- Abstract
Introduction: We report the primary analysis from JAVELIN Lung 100, a phase 3 trial comparing avelumab (anti-programmed death-ligand 1 [PD-L1]) versus platinum-based doublet chemotherapy as first-line treatment for PD-L1-positive (+) advanced NSCLC., Methods: Adults with PD-L1+ (≥1% of tumor cells; PD-L1 immunohistochemistry 73-10 pharmDx), EGFR and ALK wild-type, previously untreated, stage IV NSCLC were randomized to avelumab 10 mg/kg every 2 weeks (Q2W), avelumab 10 mg/kg once weekly (QW) for 12 weeks and Q2W thereafter, or platinum-based doublet chemotherapy every 3 weeks. Primary end points were overall survival (OS) and progression-free survival (PFS) per independent review committee. The primary analysis population was patients with high-expression PD-L1+ tumors (≥80% of tumor cells)., Results: A total of 1214 patients were randomized to avelumab Q2W (n = 366), avelumab QW (n = 322), or chemotherapy (n = 526). In the primary analysis population, hazard ratios (HRs) for OS and PFS with avelumab Q2W (n = 151) versus chemotherapy (n = 216) were 0.85 (95% confidence interval [CI]: 0.67-1.09; one-sided p = 0.1032; median OS, 20.1 versus 14.9 mo) and 0.71 (95% CI: 0.54-0.93; one-sided p = 0.0070; median PFS, 8.4 versus 5.6 mo), respectively. With avelumab QW (n = 130) versus chemotherapy (n = 129), HRs were 0.79 (95% CI: 0.59-1.07; one-sided p = 0.0630; median OS, 19.3 versus 15.3 mo) and 0.72 (95% CI: 0.52-0.98; one-sided p = 0.0196; median PFS, 7.5 versus 5.6 mo), respectively. No new safety signals were observed., Conclusions: Longer median OS and PFS were observed with avelumab versus platinum-based doublet chemotherapy in advanced NSCLC, but differences in OS and PFS were not statistically significant, and the trial did not meet its primary objective., Clinicaltrials: gov Identifier: NCT02576574., (Copyright © 2023 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.)
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- 2024
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50. Tumor Treating Fields therapy with standard systemic therapy versus standard systemic therapy alone in metastatic non-small-cell lung cancer following progression on or after platinum-based therapy (LUNAR): a randomised, open-label, pivotal phase 3 study.
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Leal T, Kotecha R, Ramlau R, Zhang L, Milanowski J, Cobo M, Roubec J, Petruzelka L, Havel L, Kalmadi S, Ward J, Andric Z, Berghmans T, Gerber DE, Kloecker G, Panikkar R, Aerts J, Delmonte A, Pless M, Greil R, Rolfo C, Akerley W, Eaton M, Iqbal M, and Langer C
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- Humans, Female, Male, Middle Aged, Immune Checkpoint Inhibitors, Nivolumab, Docetaxel, Carcinoma, Non-Small-Cell Lung therapy, Lung Neoplasms therapy
- Abstract
Background: Tumor Treating Fields (TTFields) are electric fields that disrupt processes critical for cancer cell survival, leading to immunogenic cell death and enhanced antitumour immune response. In preclinical models of non-small-cell lung cancer, TTFields amplified the effects of chemotherapy and immune checkpoint inhibitors. We report primary results from a pivotal study of TTFields therapy in metastatic non-small-cell lung cancer., Methods: This randomised, open-label, pivotal phase 3 study recruited patients at 130 sites in 19 countries. Participants were aged 22 years or older with metastatic non-small-cell lung cancer progressing on or after platinum-based therapy, with squamous or non-squamous histology and ECOG performance status of 2 or less. Previous platinum-based therapy was required, but no restriction was placed on the number or type of previous lines of systemic therapy. Participants were randomly assigned (1:1) to TTFields therapy and standard systemic therapy (investigator's choice of immune checkpoint inhibitor [nivolumab, pembrolizumab, or atezolizumab] or docetaxel) or standard therapy alone. Randomisation was performed centrally using variable blocked randomisation and an interactive voice-web response system, and was stratified by tumour histology, treatment, and region. Systemic therapies were dosed according to local practice guidelines. TTFields therapy (150 kHz) was delivered continuously to the thoracic region with the recommendation to achieve an average of at least 18 h/day device usage. The primary endpoint was overall survival in the intention-to-treat population. The safety population included all patients who received any study therapy and were analysed according to the actual treatment received. The study is registered with ClinicalTrials.gov, NCT02973789., Findings: Between Feb 13, 2017, and Nov 19, 2021, 276 patients were enrolled and randomly assigned to receive TTFields therapy with standard therapy (n=137) or standard therapy alone (n=139). The median age was 64 years (IQR 59-70), 178 (64%) were male and 98 (36%) were female, 156 (57%) had non-squamous non-small-cell lung cancer, and 87 (32%) had received a previous immune checkpoint inhibitor. Median follow-up was 10·6 months (IQR 6·1-33·7) for patients receiving TTFields therapy with standard therapy, and 9·5 months (0·1-32·1) for patients receiving standard therapy. Overall survival was significantly longer with TTFields therapy and standard therapy than with standard therapy alone (median 13·2 months [95% CI 10·3-15·5] vs 9·9 months [8·1-11·5]; hazard ratio [HR] 0·74 [95% CI 0·56-0·98]; p=0·035). In the safety population (n=267), serious adverse events of any cause were reported in 70 (53%) of 133 patients receiving TTFields therapy plus standard therapy and 51 (38%) of 134 patients receiving standard therapy alone. The most frequent grade 3-4 adverse events were leukopenia (37 [14%] of 267), pneumonia (28 [10%]), and anaemia (21 [8%]). TTFields therapy-related adverse events were reported in 95 (71%) of 133 patients; these were mostly (81 [85%]) grade 1-2 skin and subcutaneous tissue disorders. There were three deaths related to standard therapy (two due to infections and one due to pulmonary haemorrhage) and no deaths related to TTFields therapy., Interpretation: TTFields therapy added to standard therapy significantly improved overall survival compared with standard therapy alone in metastatic non-small-cell lung cancer after progression on platinum-based therapy without exacerbating systemic toxicities. These data suggest that TTFields therapy is efficacious in metastatic non-small-cell lung cancer and should be considered as a treatment option to manage the disease in this setting., Funding: Novocure., Competing Interests: Declaration of interests TL reports support towards this manuscript from Novocure; institutional grants or contracts from Advaxis and Pfizer; consulting fees from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Blueprint, Daiichi-Sankyo, Eisai, Eli Lilly, EMD Serono, Genentech, Janssen, Jazz Pharmaceuticals, Merck, Mirati, Novocure, Regeneron, Roche, and Takeda; honoraria from Aptitude Health, ASTRO, Bioascend, Cardinal Health, Curio, GRACE, I3 Health, IDEO, Larvol, Medscape, Peerview Institute for Medical Education, OncLive, Opinions in Lung Cancer, Society for Immunotherapy of Cancer, Targeted Oncology, UpToDate, and Vindico; and board participation or a leadership position for the National Cancer Institute and Georgia Society of Clinical Oncology. RK reports institutional grants or contracts from AstraZeneca, Blue Earth Diagnostics, Brainlab, Cantex Pharmaceuticals, Exelixis, GT Medical Technologies, Medtronic, Novocure, and ViewRay; consulting fees from Castle Biosciences, Elekta, Kazia Therapeutics, and ViewRay; honoraria from Accuray, Brainlab, Elekta, Elsevier, Novocure, Peerview Institute for Medical Education, and ViewRay; support for travel or meeting attendance from Accuray, Elekta, Novocure, and the Peerview Institute for Medical Education; and participation on an advisory board for ViewRay. RR reports consulting fees from Amgen, AstraZeneca, Boehringer Ingelheim, Novartis, Merck, MSD, Parexel, Pfizer, Roche, and Takeda; advising or speaking fees from Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Merck, MSD, Novartis, Parexel, Pfizer, and Roche; support for meetings or travel from Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Merck, MSD, Novartis, Parexel, Pfizer, Roche, and Takeda; and participation on an advisory board for Boehringer Ingelheim, Bristol-Myers Squibb, MSD, Novartis, Parexel, Pfizer, Roche, and Takeda. LZ reports participation on a data safety monitoring board or advisory board for AstraZeneca and BeiGene. SK reports honoraria as a speaker for AstraZeneca, Bayer, G1 Therapeutics, Genentech, and Pfizer. JW reports institutional grants from the American Cancer Society, American Lung Association, AstraZeneca, Central Society for Clinical and Translational Research, Gateway for Cancer Research, National Institutes of Health, and Siteman Cancer Center; consulting fees from Novoure and Takeda; honoraria from Washington University Continuing Medical Education and OncLive; support for travel or meeting attendance from Neon Therapuetics; and participation on a data safety monitoring or advisory board for Washington University. TB reports consultancy fees from InhaTarget; participation on a safety monitoring board or advisory board for Bayer, Bristol Myers Squibb, Daiichi-Sankyo, Janssen, Merck, and Roche; support for travel or meeting attendance from Takeda. DEG reports institutional grants from AstraZeneca, BerGenBio, Karyoparhm, and Novocure; consulting fees from Catalyst Pharmaceuticals; participation on a data safety monitoring or advisory board for BeiGene, Daiichi-Sankyo, Elevation Oncology, Janssen, Mirati, Regeneron, and Sanofi; stock or stock options with Gilead, Medtronic, and Walgreens; and a financial interest in OncoSeer Diagnostics. GK reports honoraria as a speaker or advisory board member from Amgen, AstraZeneca, Bristol-Myers Squibb, EMD Serono, Genentech, Merck, Novartis, and Regeneron; royalties from McGraw Hill; and consulting fees from Primum. RP reports institutional funding from the National Cancer Institute, and a leadership position and travel support from the National Community Oncology Dispensing Association. JA reports honoraria from AstraZeneca, Eli Lilly, and MSD; participation on a data safety monitoring or advisory board for Amphera, AstraZeneca, Bristol-Myers Squibb, MSD, and Takeda; stock or stock options with Amphera; and a leadership role with The International Association for the Study of Lung Cancer (IASLC). AD reports honoraria from Bristol-Myers Squibb; support for meeting attendance or travel from MSD and Roche; and participation on a data safety or advisory board for Novartis, Sanofi, and Takeda. MP reports consulting fees from Abbvie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eisei, Merck, MSD, Novartis, Pfizer, Roche, and Takeda; honoraria from Amgen, Bayer, Janssen, Nestle, and Sanofi; and support for meeting attendance or travel from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Roche, Takeda, and Vifor. RG reports consulting fees, honoraria, participation on a safety monitoring board or advisory board, or support for attending meetings or travel from Abbvie, Amgen, AstraZeneca, Bristol-Myers Squibb, Celgene, Daiichi Sankyo, Gilead, Janssen, Merck, MSD, Novartis, Roche, Takeda, Sandoz, and Sanofi; and stock or stock options for Eli Lilly and Novo Nordisk. CR reports institutional funding from Pfizer and U54; consulting fees from Archer, Bayer, Boston Pharm, CEA, Daiichi Sankyo, EMD Serono, Eisai, General Dynamics, Genzyme, Inivata, Janssen, Medstar, Mirati, Novartis, Regeneron, and Sanofi; honoraria from AstraZeneca, COR2ED, Intellisphere, MSD, Physicians’ Education Resource, and Roche; and leadership roles with the European Society for Medical Oncology, Elsevier, the European School of Oncology, the International Society of Liquid Biopsy, and the IASLC. WA reports institutional grants from AstraZeneca and Bristol-Myers Squibb. CL reports research funding from AstraZeneca, Eli Lilly, Fujifilm, Janssen Pharmaceuticals, Inovio, Merck, Oncocyte, Takeda, and Trizell, consulting fees from AstraZeneca, Boehringer lngelheim, Genentech/Roche, Gilead, GSK, Merck, Mirati, Novocure, Pfizer, Regeneron, Sanofi-Aventis, and Takeda; participation on a safety monitoring board or advisory board for Amgen, OncocyteDX, the Radiation Therapy Oncology Group Foundation, and the Veterans Administration; and received medical writing support from Novartis. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)
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- 2023
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