RESUMEN
Prednimustine, an ester of chlorambucil and prednisolone, was evaluated for efficacy and toxicity in a selected group of leukemia patients with a poor prognosis. Disease subsets consisted of patients with acute non-lymphocytic leukemia (ANLL) over age 60; ANLL refractory to standard therapy; smouldering leukemia; and refractory anemia with excess blasts (RAEB). In agreement with previous studies, toxicity from Prednimustine was relatively mild, consisting primarily of infrequent myelosuppression, gastrointestinal side-effects, and mild hyperglycemia. This study did not, however, confirm previously reported remission rates in ANLL: in 41 evaluable patients only two complete remissions were achieved. Both occurred in the subset of patients with smouldering leukemia. We conclude that Prednimustine has limited activity in this patient population.
Asunto(s)
Anemia Aplásica/tratamiento farmacológico , Clorambucilo/análogos & derivados , Leucemia/tratamiento farmacológico , Prednimustina/uso terapéutico , Enfermedad Aguda , Adulto , Anciano , Anemia Aplásica/sangre , Evaluación de Medicamentos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Prednimustina/administración & dosificación , Prednimustina/efectos adversosRESUMEN
A randomized, double-blind, multicenter study in 181 afebrile cancer patients with ANC levels < 500/microL receiving myelosuppressive chemotherapy was undertaken to compare sargramostim (yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor, RhuGM-CSF) and filgrastim (bacteria-derived recombinant human granulocyte colony-stimulating factor, RhuG-CSF) in the treatment of chemotherapy-induced myelosuppression. Patients received daily subcutaneous (SC) injections of either agent until ANC levels reached at least 1500/microL. There was no statistical difference between treatment groups in the mean number of days to reach an ANC of 500/microL, but the mean number of days to reach ANC levels of 1000/microL and 1500/microL was approximately one day less in patients receiving filgrastim. Fewer patients in the sargramostim arm were hospitalized, and they had a shorter mean length of hospitalization, mean duration of fever, and mean duration of i.v. antibiotic therapy compared with patients who received filgrastim. Both growth factors were well tolerated. No patient was readmitted to the hospital after growth factor was discontinued. Sargramostim and filgrastim have comparable efficacy and tolerability in the treatment of standard-dose chemotherapy-induced myelosuppression in community practice.