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

SALAR, Antonio (724 Španělsko), Irit AVIVI (376 Izrael), Beate BITTNER (756 Švýcarsko), Reda BOUABDALLAH (250 Francie), Mike BREWSTER (826 Velká Británie a Severní Irsko), Olivier CATALANI (756 Švýcarsko), George FOLLOWS (826 Velká Británie a Severní Irsko), Andrew HAYNES (826 Velká Británie a Severní Irsko), Florence HOURCADE-POTELLERET (756 Švýcarsko), Andrea JANÍKOVÁ (203 Česká republika, garant, domácí), Jean Francois LAROUCHE (124 Kanada), Christine MCINTYRE (826 Velká Británie a Severní Irsko), Michael PEDERSEN (208 Dánsko), Juliana PEREIRA (76 Brazílie), Pakeeza SAYYED (756 Švýcarsko), Ofer SHPILBERG (376 Izrael) a Gayane TUMYAN (643 Rusko)

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

Kód RIV

RIV/00216224:14110/14:00075697

Organizační jednotka

Lékařská fakulta

DOI

UT WoS

000337239600010

Klíčová slova anglicky

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

Štítky

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.