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@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 = {http://dx.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://dx.doi.org/10.1200/JCO.2013.52.2631.
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