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

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art_SALAR_Comparison_of_Subcutaneous_Versus_Intravenous_Administration_of_Rituximab_2014.PDF (239.66 KB)
Citações na Scopus
75
Tipo de produção
article
Data de publicação
2014
DOI
Scopus
Web of Science
PubMed
Título da Revista
ISSN da Revista
Título do Volume
Editora
AMER SOC CLINICAL ONCOLOGY
Autores
SALAR, Antonio
AVIVI, Irit
BITTNER, Beate
BOUABDALLAH, Reda
BREWSTER, Mike
CATALANI, Olivier
FOLLOWS, George
HAYNES, Andrew
HOURCADE-POTELLERET, Florence
JANIKOVA, Andrea
Citação
JOURNAL OF CLINICAL ONCOLOGY, v.32, n.17, p.1782-U62, 2014
Projetos de Pesquisa
Unidades Organizacionais
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Resumo
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. (C) 2014 by American Society of Clinical Oncology
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URI
https://observatorio.fm.usp.br/handle/OPI/7335
Referências
  1. Bai S, 2012, CLIN PHARMACOKINET, V51, P119, DOI 10.2165/11596370-000000000-00000
  2. Bookbinder LH, 2006, J CONTROL RELEASE, V114, P230, DOI 10.1016/j.jconrel.2006.05.027
  3. Cartron G, 2004, BLOOD, V104, P2635, DOI 10.1182/blood-2004-03-1110
  4. Coiffier B, 2002, NEW ENGL J MED, V346, P235, DOI 10.1056/NEJMoa011795
  5. Coiffier B, 2010, BLOOD, V116, P2040, DOI 10.1182/blood-2010-03-276246
  6. Coiffier B, 1998, BLOOD, V92, P1927
  7. Davies A, 2012, 54 AM SOC HEM ANN M
  8. De Cock E, 2013, 18 EUR HEM ASS ANN C
  9. Dreyling M, 2011, ANN ONCOL S, V22, pvi59, DOI 10.1093/ANN0NC/MDR388
  10. Forstpointner R, 2006, BLOOD, V108, P4003, DOI 10.1182/blood-2006-04-016725
  11. Frost GI, 2007, EXPERT OPIN DRUG DEL, V4, P427, DOI 10.1517/17425247.4.4.427
  12. Ghielmini M, 2013, ANN ONCOL, V24, P561, DOI 10.1093/annonc/mds517
  13. Ghielmini M, 2004, BLOOD, V103, P4416, DOI 10.1182/blood-2003-10-3411
  14. Hallek M, 2010, LANCET, V376, P1164, DOI 10.1016/S0140-6736(10)61381-5
  15. Harb G, 2010, CURR MED RES OPIN, V26, P279, DOI 10.1185/03007990903432900
  16. Hiddemann W, 2005, BLOOD, V106, P3725, DOI 10.1182/blood-2005-01-0016
  17. Hochster H, 2009, J CLIN ONCOL, V27, P1607, DOI 10.1200/JCO.2008.17.1561
  18. Ismael G, 2012, LANCET ONCOL, V13, P869, DOI 10.1016/S1470-2045(12)70329-7
  19. Keating M, 2000, SEMIN ONCOL, V27, P86
  20. Lundin J, 2002, BLOOD, V100, P768, DOI 10.1182/blood-2002-01-0159
  21. Marcus R, 2008, J CLIN ONCOL, V26, P4579, DOI 10.1200/JCO.2007.13.5376
  22. Moreau P, 2008, HAEMATOL-HEMATOL J, V93, P1908, DOI 10.3324/haematol.13285
  23. Moreau P, 2011, LANCET ONCOL, V12, P431, DOI 10.1016/S1470-2045(11)70081-X
  24. National Comprehensive Cancer Network, 2013, CLIN PRACT GUID ONC
  25. O'Brien SM, 2001, J CLIN ONCOL, V19, P2165
  26. Pivot X, 2013, 13 ST GALL INT BREAS
  27. REFF ME, 1994, BLOOD, V83, P435
  28. Salar A, 2010, BLOOD, V116
  29. Salles G, 2011, LANCET, V377, P42, DOI 10.1016/S0140-6736(10)62175-7
  30. Stilgenbauer S, 2009, J CLIN ONCOL, V27, P3994, DOI 10.1200/JCO.2008.21.1128
  31. Thomas JR, 2009, J PAIN SYMPTOM MANAG, V38, P663, DOI 10.1016/j.jpainsymman.2009.03.009
  32. van Oers MHJ, 2010, J CLIN ONCOL, V28, P2853, DOI 10.1200/JCO.2009.26.5827
  33. van Oers MHJ, 2006, BLOOD, V108, P3295, DOI 10.1182/blood-2006-05-021113
  34. Velagapudi R, 2005, CLIN PHARMACOL THER, V77, pP84, DOI 10.1016/j.clpt.2004.12.212
  35. Vogel Wendy H, 2010, Clin J Oncol Nurs, V14, pE10, DOI 10.1188/10.CJON.E10-E21
  36. Yin A, 2010, J CLIN ONCOL S, V28

Coleções
Artigos e Materiais de Revistas Científicas - FM/MCM
Artigos e Materiais de Revistas Científicas - HC/ICHC
Artigos e Materiais de Revistas Científicas - LIM/31
Artigos e Materiais de Revistas Científicas - ODS/03