RESUMEN
BACKGROUND AND OBJECTIVES: Although bendamustine has been used for more than 30 years in the treatment of lymphoma, little is known about the optimal dosing schedule in relapsed or refractory B-cell chronic lymphocytic leukemia (CLL). Various dose and treatment schedules have been used empirically, and several phase II studies have shown impressive efficacy. To determine the maximal tolerated dose, dose-limiting toxicity and the optimal therapeutic dose of bendamustine for further phase III clinical trials the GCLLSG designed a phase I/II study for pre-treated CLL patients. DESIGN AND METHODS: Sixteen patients (median age 67 years) with relapsed or refractory CLL were enrolled. All patients had been pre-treated with a median of three different regimens. Bendamustine was given at a starting dose of 100 mg/m2 on day 1 and 2, repeated every 3-4 weeks. RESULTS: Major toxicities were leukocytopenia (CTC grade 3+4) in 8/16 and infections (CTC grade 3+4) in 7/16 patients. Six patients had dose-limiting toxicity which led to dose de-escalation from 100 to 70 mg/m2 in three patients. The maximum tolerated dose was 70 mg/m2. According to NCI-WG criteria, 9/16 patients (56%) responded to therapy, seven to doses Asunto(s)
Leucemia Linfocítica Crónica de Células B/tratamiento farmacológico
, Leucemia Linfocítica Crónica de Células B/prevención & control
, Compuestos de Mostaza Nitrogenada/uso terapéutico
, Anciano
, Anciano de 80 o más Años
, Clorhidrato de Bendamustina
, Relación Dosis-Respuesta a Droga
, Femenino
, Estudios de Seguimiento
, Alemania/epidemiología
, Humanos
, Leucemia Linfocítica Crónica de Células B/epidemiología
, Masculino
, Persona de Mediana Edad
, Recurrencia Local de Neoplasia/prevención & control
, Análisis de Supervivencia