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@article{958021, author = {Coiffier, Bertrand and Osmanov, Evgenii A. and Hong, Xiaonan and Scheliga, Adriana and Mayer, Jiří and Offner, Fritz and Rule, Simon and Teixeira, Adriana and Walewski, Jan and de Vos, Sven and Crump, Michael and Shpilberg, Ofer and Esseltine, DixieandLee and Zhu, Eugene and Enny, Christopher and Theocharous, Panteli and van de Velde, Helgi and Elsayed, Yusri A. and Zinzani, Pier Luigi}, article_number = {8}, doi = {http://dx.doi.org/10.1016/S1470-2045(11)70150-4}, keywords = {NON-HODGKINS-LYMPHOMA; MANTLE CELL LYMPHOMAS; INDOLENT LYMPHOMA; LOW-GRADE; MAINTENANCE THERAPY; MULTIPLE-MYELOMA; CYCLOPHOSPHAMIDE; COMBINATION; PREDNISONE; VINCRISTINE}, language = {eng}, issn = {1470-2045}, journal = {Lancet Oncology}, title = {Bortezomib plus rituximab versus rituximab alone in patients with relapsed, rituximab-naive or rituximab-sensitive, follicular lymphoma: a randomised phase 3 trial}, volume = {12}, year = {2011} }
TY - JOUR ID - 958021 AU - Coiffier, Bertrand - Osmanov, Evgenii A. - Hong, Xiaonan - Scheliga, Adriana - Mayer, Jiří - Offner, Fritz - Rule, Simon - Teixeira, Adriana - Walewski, Jan - de Vos, Sven - Crump, Michael - Shpilberg, Ofer - Esseltine, Dixie-Lee - Zhu, Eugene - Enny, Christopher - Theocharous, Panteli - van de Velde, Helgi - Elsayed, Yusri A. - Zinzani, Pier Luigi PY - 2011 TI - Bortezomib plus rituximab versus rituximab alone in patients with relapsed, rituximab-naive or rituximab-sensitive, follicular lymphoma: a randomised phase 3 trial JF - Lancet Oncology VL - 12 IS - 8 SP - 773-784 EP - 773-784 SN - 14702045 KW - NON-HODGKINS-LYMPHOMA KW - MANTLE CELL LYMPHOMAS KW - INDOLENT LYMPHOMA KW - LOW-GRADE KW - MAINTENANCE THERAPY KW - MULTIPLE-MYELOMA KW - CYCLOPHOSPHAMIDE KW - COMBINATION KW - PREDNISONE KW - VINCRISTINE N2 - Background 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. Methods In this multicentre phase 3 trial, rituximab-naive or rituximab-sensitive patients aged 18 years or older with relapsed grade 1 or 2 follicular lymphoma were randomly assigned (1: 1) to receive five 35-day cycles consisting of intravenous infusions of rituximab 375 mg/m(2) on days 1, 8, 15, and 22 of cycle 1, and on day 1 of cycles 2-5, either alone or with bortezomib 1 . 6 mg/m(2), administered by intravenous injection on days 1, 8, 15, and 22 of all cycles. Randomisation was stratified by FLIPI score, previous use of rituximab, time since last therapy, and region. Treatment assignment was based on a computer-generated randomisation schedule prepared by the sponsor. Patients and treating physicians were not masked to treatment allocation. The primary endpoint was progression-free survival analysed by intention to treat. This trial has been completed and is registered with ClinicalTrials.gov, number NCT00312845. ER -
COIFFIER, Bertrand, Evgenii A. OSMANOV, Xiaonan HONG, Adriana SCHELIGA, Jiří MAYER, Fritz OFFNER, Simon RULE, Adriana TEIXEIRA, Jan WALEWSKI, Sven DE VOS, Michael CRUMP, Ofer SHPILBERG, Dixie-Lee ESSELTINE, Eugene ZHU, Christopher ENNY, Panteli THEOCHAROUS, Helgi VAN DE VELDE, Yusri A. ELSAYED a Pier Luigi ZINZANI. Bortezomib plus rituximab versus rituximab alone in patients with relapsed, rituximab-naive or rituximab-sensitive, follicular lymphoma: a randomised phase 3 trial. \textit{Lancet Oncology}. 2011, roč.~12, č.~8, s.~773-784. ISSN~1470-2045. Dostupné z: https://dx.doi.org/10.1016/S1470-2045(11)70150-4.
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