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Comparison of subcutaneous versus intravenous administration of rituximab as maintenance treatment for follicular lymphoma: results from a two-stage, phase IB study

A. Salar, I. Avivi, B. Bittner, R. Bouabdallah, M. Brewster, O. Catalani, G. Follows, A. Haynes, F. Hourcade-Potelleret, A. Janikova, JF. Larouche, C. McIntyre, M. Pedersen, J. Pereira, P. Sayyed, O. Shpilberg, G. Tumyan,

. 2014 ; 32 (17) : 1782-91.

Jazyk angličtina Země Spojené státy americké

Typ dokumentu klinické zkoušky, fáze I, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc15008055

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/m2, 625 mg/m2, or an additional group at 800 mg/m2) or IV rituximab (375 mg/m2). The objective was to determine an SC dose that would yield a rituximab serum trough concentration (Ctrough) 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/m2) given at 2- or 3-month intervals. The objective was to demonstrate noninferior rituximab Ctrough of SC rituximab relative to IV rituximab 375 mg/m2. RESULTS: Stage 1 data predicted that a fixed dose of 1,400 mg SC rituximab would result in a serum Ctrough 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 Ctrough SC:Ctrough 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 Ctrough levels relative to IV rituximab 375 mg/m2 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.

Citace poskytuje Crossref.org

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$a Salar, Antonio $u Antonio Salar, Hospital del Mar, Barcelona, Spain; Irit Avivi, Rambam Medical Center, Haifa; Ofer Shpilberg, Tel Aviv University, Tel Aviv, Israel; Beate Bittner, Olivier Catalani, Florence Hourcade-Potelleret, and Pakeeza Sayyed, F. Hoffmann-La Roche, Basel, Switzerland; Reda Bouabdallah, Institut Paoli-Calmettes, Marseille, France; Mike Brewster and Christine McIntyre, Roche Products, Welwyn Garden City; George Follows, Addenbrooke's Hospital, University of Cambridge, Cambridge; Andrew Haynes, Nottingham City Hospital, Nottingham, United Kingdom; Andrea Janikova, University Hospital Brno, Brno, Czech Republic; Jean-François Larouche, Hôpital de l'Enfant-Jésus, Centre Hospitalier Universitaire de Québec, Québec, Canada; Michael Pedersen, Herlev Hospital, Herlev, Denmark; Juliana Pereira, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil; and Gayane Tumyan, Russian Cancer Research Center, Moscow, Russia. 94131@parcdesalutmar.cat.
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$a 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/m2, 625 mg/m2, or an additional group at 800 mg/m2) or IV rituximab (375 mg/m2). The objective was to determine an SC dose that would yield a rituximab serum trough concentration (Ctrough) 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/m2) given at 2- or 3-month intervals. The objective was to demonstrate noninferior rituximab Ctrough of SC rituximab relative to IV rituximab 375 mg/m2. RESULTS: Stage 1 data predicted that a fixed dose of 1,400 mg SC rituximab would result in a serum Ctrough 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 Ctrough SC:Ctrough 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 Ctrough levels relative to IV rituximab 375 mg/m2 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.
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$a McIntyre, Christine $u Antonio Salar, Hospital del Mar, Barcelona, Spain; Irit Avivi, Rambam Medical Center, Haifa; Ofer Shpilberg, Tel Aviv University, Tel Aviv, Israel; Beate Bittner, Olivier Catalani, Florence Hourcade-Potelleret, and Pakeeza Sayyed, F. Hoffmann-La Roche, Basel, Switzerland; Reda Bouabdallah, Institut Paoli-Calmettes, Marseille, France; Mike Brewster and Christine McIntyre, Roche Products, Welwyn Garden City; George Follows, Addenbrooke's Hospital, University of Cambridge, Cambridge; Andrew Haynes, Nottingham City Hospital, Nottingham, United Kingdom; Andrea Janikova, University Hospital Brno, Brno, Czech Republic; Jean-François Larouche, Hôpital de l'Enfant-Jésus, Centre Hospitalier Universitaire de Québec, Québec, Canada; Michael Pedersen, Herlev Hospital, Herlev, Denmark; Juliana Pereira, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil; and Gayane Tumyan, Russian Cancer Research Center, Moscow, Russia.
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$a Pedersen, Michael $u Antonio Salar, Hospital del Mar, Barcelona, Spain; Irit Avivi, Rambam Medical Center, Haifa; Ofer Shpilberg, Tel Aviv University, Tel Aviv, Israel; Beate Bittner, Olivier Catalani, Florence Hourcade-Potelleret, and Pakeeza Sayyed, F. Hoffmann-La Roche, Basel, Switzerland; Reda Bouabdallah, Institut Paoli-Calmettes, Marseille, France; Mike Brewster and Christine McIntyre, Roche Products, Welwyn Garden City; George Follows, Addenbrooke's Hospital, University of Cambridge, Cambridge; Andrew Haynes, Nottingham City Hospital, Nottingham, United Kingdom; Andrea Janikova, University Hospital Brno, Brno, Czech Republic; Jean-François Larouche, Hôpital de l'Enfant-Jésus, Centre Hospitalier Universitaire de Québec, Québec, Canada; Michael Pedersen, Herlev Hospital, Herlev, Denmark; Juliana Pereira, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil; and Gayane Tumyan, Russian Cancer Research Center, Moscow, Russia.
700    1_
$a Pereira, Juliana $u Antonio Salar, Hospital del Mar, Barcelona, Spain; Irit Avivi, Rambam Medical Center, Haifa; Ofer Shpilberg, Tel Aviv University, Tel Aviv, Israel; Beate Bittner, Olivier Catalani, Florence Hourcade-Potelleret, and Pakeeza Sayyed, F. Hoffmann-La Roche, Basel, Switzerland; Reda Bouabdallah, Institut Paoli-Calmettes, Marseille, France; Mike Brewster and Christine McIntyre, Roche Products, Welwyn Garden City; George Follows, Addenbrooke's Hospital, University of Cambridge, Cambridge; Andrew Haynes, Nottingham City Hospital, Nottingham, United Kingdom; Andrea Janikova, University Hospital Brno, Brno, Czech Republic; Jean-François Larouche, Hôpital de l'Enfant-Jésus, Centre Hospitalier Universitaire de Québec, Québec, Canada; Michael Pedersen, Herlev Hospital, Herlev, Denmark; Juliana Pereira, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil; and Gayane Tumyan, Russian Cancer Research Center, Moscow, Russia.
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700    1_
$a Tumyan, Gayane $u Antonio Salar, Hospital del Mar, Barcelona, Spain; Irit Avivi, Rambam Medical Center, Haifa; Ofer Shpilberg, Tel Aviv University, Tel Aviv, Israel; Beate Bittner, Olivier Catalani, Florence Hourcade-Potelleret, and Pakeeza Sayyed, F. Hoffmann-La Roche, Basel, Switzerland; Reda Bouabdallah, Institut Paoli-Calmettes, Marseille, France; Mike Brewster and Christine McIntyre, Roche Products, Welwyn Garden City; George Follows, Addenbrooke's Hospital, University of Cambridge, Cambridge; Andrew Haynes, Nottingham City Hospital, Nottingham, United Kingdom; Andrea Janikova, University Hospital Brno, Brno, Czech Republic; Jean-François Larouche, Hôpital de l'Enfant-Jésus, Centre Hospitalier Universitaire de Québec, Québec, Canada; Michael Pedersen, Herlev Hospital, Herlev, Denmark; Juliana Pereira, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil; and Gayane Tumyan, Russian Cancer Research Center, Moscow, Russia.
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