Comparison of Subcutaneous Versus Intravenous Administration of
Rituximab As Maintenance Treatment for Follicular Lymphoma:
Results From a Two-Stage, Phase IB Study

J 2014

Comparison of Subcutaneous Versus Intravenous Administration of Rituximab As Maintenance Treatment for Follicular Lymphoma: Results From a Two-Stage, Phase IB Study

SALAR, Antonio; Irit AVIVI; Beate BITTNER; Reda BOUABDALLAH; Mike BREWSTER et al.

Základní údaje

Originální název

Comparison of Subcutaneous Versus Intravenous Administration of Rituximab As Maintenance Treatment for Follicular Lymphoma: Results From a Two-Stage, Phase IB Study

Autoři

Vydání

Journal of clinical oncology, United States, American Society of Clinical Oncology, 2014, 0732-183X

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: 18.443

Označené pro přenos do RIV

Ano

Kód RIV

RIV/00216224:14110/14:00075697

Organizační jednotka

Lékařská fakulta

Klíčová slova anglicky

CHRONIC LYMPHOCYTIC-LEUKEMIA; B-CELL LYMPHOMA; MONOCLONAL-ANTIBODY; RESPONSE DURATION; CHOP CHEMOTHERAPY; MULTIPLE-MYELOMA; FREE SURVIVAL; OPEN-LABEL; TRIAL; CYCLOPHOSPHAMIDE

Štítky

EL OK

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 24. 4. 2015 14:32, Soňa Böhmová

Anotace

V originále

Purpose This two-stage phase IB study investigated the pharmacokinetics and safety of subcutaneous (SC) versus intravenous (IV) administration of rituximab as maintenance therapy in follicular lymphoma. Patients and Methods In stage 1 (dose finding), 124 patients who responded to rituximab induction were randomly assigned to SC rituximab (375 mg/m(2), 625 mg/m(2), or an additional group at 800 mg/m(2)) or IV rituximab (375 mg/m(2)). The objective was to determine an SC dose that would yield a rituximab serum trough concentration (C-trough) in the same range as that of IV rituximab. In stage 2, 154 additional patients were randomly assigned (1: 1) to SC rituximab (1,400 mg) or IV rituximab (375 mg/m(2)) given at 2-or 3-month intervals. The objective was to demonstrate noninferior rituximab C-trough of SC rituximab relative to IV rituximab 375 mg/m(2). Results Stage 1 data predicted that a fixed dose of 1,400 mg SC rituximab would result in a serum C-trough in the range of that of IV rituximab. Noninferiority (ie, meeting the prespecified 90% CI lower limit of 0.8) was then confirmed in stage 2, with geometric mean C-trough (SC): C-trough (IV) ratios for the 2-and 3-month regimens of 1.24 (90% CI, 1.02 to 1.51) and 1.12 (90% CI, 0.86 to 1.45), respectively. Overall safety profiles were similar between formulations (in stage 2, 79% of patients experienced one or more adverse events in each group). Local administration-related reactions (mainly mild to moderate) occurred more frequently after SC administration. Conclusion The fixed dose of 1,400 mg SC rituximab predicted by using stage 1 results was confirmed to have noninferior C-trough levels relative to IV rituximab 375 mg/m(2) dosing during maintenance, with a comparable safety profile. Additional investigation will be required to determine whether the SC route of administration for rituximab provides equivalent efficacy compared with that of IV administration.

Citovat

SALAR, Antonio; Irit AVIVI; Beate BITTNER; Reda BOUABDALLAH; Mike BREWSTER; Olivier CATALANI; George FOLLOWS; Andrew HAYNES; Florence HOURCADE-POTELLERET; Andrea JANÍKOVÁ; Jean Francois LAROUCHE; Christine MCINTYRE; Michael PEDERSEN; Juliana PEREIRA; Pakeeza SAYYED; Ofer SHPILBERG a Gayane TUMYAN. Comparison of Subcutaneous Versus Intravenous Administration of Rituximab As Maintenance Treatment for Follicular Lymphoma: Results From a Two-Stage, Phase IB Study. Journal of clinical oncology. United States: American Society of Clinical Oncology, 2014, roč. 32, č. 17, s. 1782-1791, 11 s. ISSN 0732-183X. Dostupné z: https://doi.org/10.1200/JCO.2013.52.2631.

@article{1185582,
   author = {Salar, Antonio and Avivi, Irit and Bittner, Beate and Bouabdallah, Reda and Brewster, Mike and Catalani, Olivier and Follows, George and Haynes, Andrew and HourcadeandPotelleret, Florence and Janíková, Andrea and Larouche, Jean Francois and McIntyre, Christine and Pedersen, Michael and Pereira, Juliana and Sayyed, Pakeeza and Shpilberg, Ofer and Tumyan, Gayane},
   article_location = {United States},
   article_number = {17},
   doi = {https://doi.org/10.1200/JCO.2013.52.2631},
   keywords = {CHRONIC LYMPHOCYTIC-LEUKEMIA; B-CELL LYMPHOMA; MONOCLONAL-ANTIBODY; RESPONSE DURATION; CHOP CHEMOTHERAPY; MULTIPLE-MYELOMA; FREE SURVIVAL; OPEN-LABEL; TRIAL; CYCLOPHOSPHAMIDE},
   language = {eng},
   issn = {0732-183X},
   journal = {Journal of clinical oncology},
   title = {Comparison of Subcutaneous Versus Intravenous Administration of Rituximab As Maintenance Treatment for Follicular Lymphoma: Results From a Two-Stage, Phase IB Study},
   volume = {32},
   year = {2014}
}

TY  - JOUR
ID  - 1185582
AU  - Salar, Antonio - Avivi, Irit - Bittner, Beate - Bouabdallah, Reda - Brewster, Mike - Catalani, Olivier - Follows, George - Haynes, Andrew - Hourcade-Potelleret, Florence - Janíková, Andrea - Larouche, Jean Francois - McIntyre, Christine - Pedersen, Michael - Pereira, Juliana - Sayyed, Pakeeza - Shpilberg, Ofer - Tumyan, Gayane
PY  - 2014
TI  - Comparison of Subcutaneous Versus Intravenous Administration of Rituximab As Maintenance Treatment for Follicular Lymphoma: Results From a Two-Stage, Phase IB Study
JF  - Journal of clinical oncology
VL  - 32
IS  - 17
SP  - 1782-1791
EP  - 1782-1791
PB  - American Society of Clinical Oncology
SN  - 0732183X
KW  - CHRONIC LYMPHOCYTIC-LEUKEMIA
KW  - B-CELL LYMPHOMA
KW  - MONOCLONAL-ANTIBODY
KW  - RESPONSE DURATION
KW  - CHOP CHEMOTHERAPY
KW  - MULTIPLE-MYELOMA
KW  - FREE SURVIVAL
KW  - OPEN-LABEL
KW  - TRIAL
KW  - CYCLOPHOSPHAMIDE
N2  - Purpose This two-stage phase IB study investigated the pharmacokinetics and safety of subcutaneous (SC) versus intravenous (IV) administration of rituximab as maintenance therapy in follicular lymphoma. Patients and Methods In stage 1 (dose finding), 124 patients who responded to rituximab induction were randomly assigned to SC rituximab (375 mg/m(2), 625 mg/m(2), or an additional group at 800 mg/m(2)) or IV rituximab (375 mg/m(2)). The objective was to determine an SC dose that would yield a rituximab serum trough concentration (C-trough) in the same range as that of IV rituximab. In stage 2, 154 additional patients were randomly assigned (1: 1) to SC rituximab (1,400 mg) or IV rituximab (375 mg/m(2)) given at 2-or 3-month intervals. The objective was to demonstrate noninferior rituximab C-trough of SC rituximab relative to IV rituximab 375 mg/m(2). Results Stage 1 data predicted that a fixed dose of 1,400 mg SC rituximab would result in a serum C-trough in the range of that of IV rituximab. Noninferiority (ie, meeting the prespecified 90% CI lower limit of 0.8) was then confirmed in stage 2, with geometric mean C-trough (SC): C-trough (IV) ratios for the 2-and 3-month regimens of 1.24 (90% CI, 1.02 to 1.51) and 1.12 (90% CI, 0.86 to 1.45), respectively. Overall safety profiles were similar between formulations (in stage 2, 79% of patients experienced one or more adverse events in each group). Local administration-related reactions (mainly mild to moderate) occurred more frequently after SC administration. Conclusion The fixed dose of 1,400 mg SC rituximab predicted by using stage 1 results was confirmed to have noninferior C-trough levels relative to IV rituximab 375 mg/m(2) dosing during maintenance, with a comparable safety profile. Additional investigation will be required to determine whether the SC route of administration for rituximab provides equivalent efficacy compared with that of IV administration.
ER  -

SALAR, Antonio; Irit AVIVI; Beate BITTNER; Reda BOUABDALLAH; Mike BREWSTER; Olivier CATALANI; George FOLLOWS; Andrew HAYNES; Florence HOURCADE-POTELLERET; Andrea JANÍKOVÁ; Jean Francois LAROUCHE; Christine MCINTYRE; Michael PEDERSEN; Juliana PEREIRA; Pakeeza SAYYED; Ofer SHPILBERG a Gayane TUMYAN. Comparison of Subcutaneous Versus Intravenous Administration of Rituximab As Maintenance Treatment for Follicular Lymphoma: Results From a Two-Stage, Phase IB Study. \textit{Journal of clinical oncology}. United States: American Society of Clinical Oncology, 2014, roč.~32, č.~17, s.~1782-1791, 11 s. ISSN~0732-183X. Dostupné z: https://doi.org/10.1200/JCO.2013.52.2631.

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