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

J 2011

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

COIFFIER, Bertrand; Evgenii A. OSMANOV; Xiaonan HONG; Adriana SCHELIGA; Jiří MAYER et al.

Základní údaje

Originální název

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

Autoři

Vydání

Lancet Oncology, 2011, 1470-2045

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30200 3.2 Clinical medicine

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 22.589

Označené pro přenos do RIV

Ano

Kód RIV

RIV/00216224:14110/11:00053916

Organizační jednotka

Lékařská fakulta

DOI

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

UT WoS

000293272100028

Klíčová slova anglicky

NON-HODGKINS-LYMPHOMA; MANTLE CELL LYMPHOMAS; INDOLENT LYMPHOMA; LOW-GRADE; MAINTENANCE THERAPY; MULTIPLE-MYELOMA; CYCLOPHOSPHAMIDE; COMBINATION; PREDNISONE; VINCRISTINE

Příznaky

Mezinárodní význam

Změněno: 14. 11. 2011 16:03, Mgr. Michal Petr

Anotace

V originále

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.

Citovat

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. Lancet Oncology. 2011, roč. 12, č. 8, s. 773-784. ISSN 1470-2045. Dostupné z: https://doi.org/10.1016/S1470-2045(11)70150-4.

@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 = {https://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://doi.org/10.1016/S1470-2045(11)70150-4.

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