Bortezomib plus rituximab versus rituximab alone in patients with relapsed, rituximab-naive or rituximab-sensitive, follicular lymphoma: a randomised phase 3 trial

Coiffier, B; Osmanov, E; Hong, X; Scheliga, A; Mayer, J; Offner, F; Rule, S; Teixeira, A; Walewski, J; de Vos, S; Crump, M; Shpilberg, O; Esseltine, D; Zhu, E; Enny, C; Theocharous, P; van de Velde, H; Elsayed, Y; Zinzani, P; Abdulkadyrov, K; Afanasiev, B; Aguayo Gonzalez, A; Andre, M; Belada, D; Ben Yehuda, D; Bezares, R; Biakhov, M; Bolam, S; Borbenyi, Z; Bron, D; Buckstein, R; Bumbea, H; Caballero Barrigon, M; Campos, L; Cantonetti, M; Capra Zanella, M; Christiansen, N; Cohen, G; Colita, N; Cosgriff, T; Crump, M; Culligan, D; Del Giglio, A; Dichmann, R; Dietzfelbinger, H; Digumarti, R; Dmoszynska, A; Domnikova, N; Dubinsky, P; Dunaev, Y; Easow, J; Eberwine, S; Economopoulos, T; Egyed, M; Ellerton, J; Eom, H; Farmer, L; Fenske, T; Fields, P; Fillet, G; Frank, R; Gaisarova, G; Garicochea, B; Gasztonyi, Z; Gavish, I; Gheorghita, E; Gladkov, O; Goldberg, V; Golenkov, A; Gomez Almaguer, D; Gonzalez Barca, E; Guan, Z; Gupta, S; Hellmann, A; Hermann, R; Honkanen, T; Hu, E; Huang, X; Hudecek, J; Illes, A; Intragumtornchai, T; Jedrzejczak, W; Jones, L; Jootar, S; Kahanic, S; Karamanesht, E; Ke, X; Khuageva, N; Kim, W; Kimby, E; Komisarenko, V; Kouroukis, T; Kuliczkowski, K; Kuzina, L; Kyselyova, M; Labanca, V; Lange, A; Le Gouill, S; Leahy, M; Liberati, A; Linden, O; Liu, T; Lubennikov, V; Lundin, J; Lysa, T; Lysenko, I; Lytvyn, I; Makhson, A; Manikhas, G; Masliak, Z; Mcintyre, R; Medvedeva, N; Mena, R; Merkulov, V; Mesters, R; Milpied, N; Min, Y; Moezi, M; Mohrbacher, A; Mollee, P; Morgan, D; Morschhauser, F; Mysanikov, A; Nagler, A; Nair, S; Naparstek, E; Nawarawong, W; Noga, S; Oliveira, I; Okada, C; Oriol Rocafiguera, A; Page, R; Papajik, T; Pasquini, R; Patel, M; Patel, R; Paton, E; Pavlov, V; Pospelova, T; Prasad, S; Pylypenko, H; Raposo, J; Rekhtman, G; Rivas, S; Robak, T; Saba, S; Salles, G; Saltzman, M; Samoilova, O; Samuels, B; Sanani, S; Sebban, C; Silva da Gomes, M; Shen, Z; Shi, Y; Shtalrid, M; Siritanaratkul, N; Skotnicki, A; Solal Celigny, P; Soubeyran, P; Spencer, A; Stevens, D; Suh, C; Sulek, K; Suvorov, A; Szer, J; Theunissen, K; To Bik, L; Tothova, E; Trneny, M; Van De Velde, A; Van Hoof, A; Van Steenweghen, S; Vanhatalo, S; Varma, S; Vidyasagar, M; Vilchevskaya, K; Vitolo, U; Wang, H; Warzocha, K; Wild, A; Zachee, P; Zanichelli, M; Zhang, W; Zoppegno, L; Zoumbos, N

doi:10.1016/S1470-2045(11)70150-4

Bortezomib and rituximab have shown additive activity in preclinical models of lymphoma, and have been shown to be active and generally well tolerated in a randomised phase 2 study in patients with follicular and marginal zone lymphoma. We compared the efficacy and safety of rituximab alone or combined with bortezomib in patients with relapsed or refractory follicular lymphoma in a phase 3 setting.

Coiffier, B., Osmanov, E., Hong, X., Scheliga, A., Mayer, J., Offner, F., et al. (2011). Bortezomib plus rituximab versus rituximab alone in patients with relapsed, rituximab-naive or rituximab-sensitive, follicular lymphoma: a randomised phase 3 trial. THE LANCET ONCOLOGY, 12(8), 773-784 [10.1016/S1470-2045(11)70150-4].