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QJM ; 104(11): 957-70, 2011 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-21752867

RESUMEN

BACKGROUND: Bortezomib is approved for the treatment of multiple myeloma and a role has been suggested in the treatment of systemic AL amyloidosis (AL). METHODS: In this phase 1 dose-escalation portion of the first prospective study of single-agent bortezomib in AL, 31 patients with relapsed disease, including 14 (45%) with cardiac involvement, received bortezomib in seven dose cohorts on once-weekly (0.7, 1.0, 1.3, 1.6 mg/m(2)) and twice-weekly (0.7, 1.0, 1.3 mg/m(2)) schedules. Electrocardiographic, Holter and echocardiographic studies were evaluated in all patients to determine safety and response. RESULTS: During therapy (median treatment period 210 days), no patient developed significant ventricular or supraventricular rhythm disturbance on 24-h Holter monitoring; however, no patient satisfied study criteria for cardiac response using echocardiographic assessment or New York Heart Association classification. Seven patients (23%) had a ≥ 10% fall in left ventricular ejection fraction, but only one met criteria for cardiac deterioration. The predominant cardiac adverse events were peripheral edema (23%), orthostatic hypotension (13%) and hypotension (10%). Two patients developed grade 3 congestive heart failure, which resolved following treatment interruption. In this Phase 1 portion, the maximum tolerated dose of bortezomib on either schedule was not reached. Hematologic responses occurred in 14 patients (45%), including seven (23%) complete responses. In non-responders mean left ventricular wall thickness increased during the course of treatment. CONCLUSION: AL is frequently rapidly progressive; in these patients who had relapsed or progressed following previous conventional therapies, these results suggest that bortezomib may slow the progression of cardiac amyloid with limited toxicity.


Asunto(s)
Amiloidosis/tratamiento farmacológico , Antineoplásicos/administración & dosificación , Ácidos Borónicos/administración & dosificación , Cardiopatías/tratamiento farmacológico , Pirazinas/administración & dosificación , Anciano , Amiloidosis/complicaciones , Bortezomib , Progresión de la Enfermedad , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Electrocardiografía , Femenino , Cardiopatías/etiología , Humanos , Enfermedades Renales/tratamiento farmacológico , Enfermedades Renales/etiología , Hepatopatías/tratamiento farmacológico , Hepatopatías/etiología , Masculino , Dosis Máxima Tolerada , Persona de Mediana Edad , Paraproteinemias/complicaciones , Enfermedades del Sistema Nervioso Periférico/tratamiento farmacológico , Enfermedades del Sistema Nervioso Periférico/etiología , Estudios Prospectivos , Resultado del Tratamiento
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