Prospective comparison of subcutaneous versus intravenous administration of bortezomib in patients with multiple myeloma.
Haematologica
; 93(12): 1908-11, 2008 Dec.
Article
en En
| MEDLINE
| ID: mdl-18768528
ABSTRACT
This phase I study compared pharmacokinetics and pharmacodynamics, and assessed safety and efficacy of intravenous and subcutaneous administration of bortezomib. Relapsed or refractory multiple myeloma patients were randomized to receive bortezomib by standard intravenous bolus (n=12) or subcutaneous injection (n=12) at the recommended dose and schedule (1.3 mg/m2, days 1, 4, 8, 11; eight 21-day cycles). Plasma bortezomib concentration and percent 20S proteasome inhibition were measured at multiple time points on days 1 and 11, cycle 1. Systemic bortezomib exposure was similar between arms. As expected, mean maximum plasma concentration was lower and took longer to reach following subcutaneous administration. Overall 20S proteasome inhibition was similar between arms. Safety profile and response rate for the subcutaneous arm did not appear inferior to the intravenous arm, with good local tolerance of subcutaneous injection. Based on these exploratory findings, subcutaneous administration offers an alternative option to intravenous injection (ClinicalTrials.gov identifier NCT00291538).
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Pirazinas
/
Ácidos Borónicos
/
Antineoplásicos
Tipo de estudio:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
Límite:
Humans
/
Middle aged
Idioma:
En
Revista:
Haematologica
Año:
2008
Tipo del documento:
Article
País de afiliación:
Francia