RESUMO
In an attempt to substitute ftorafur for burdensome 5-fluorouracil (5-FU) infusions, 52 previously untreated patients were randomized to receive ftorafur with either mitomycin C or methyl-CCNU. Ftorafur was administered monthly as a 2-hour infusion daily x 5 days. Mitomycin C and methyl-CCNU were repeated every 8 weeks. A response rate of 27% (seven responses among 26 patients) was demonstrated on the mitomycin C arm compared to a response rate of 15% (four responses among 26 patients) on the methyl-CCNU arm (P = 0.25). There was no significant difference in the median survival between treatment arms. Central nervous system toxicity occurred in greater than 30% of the patients and appeared to be the limiting factor with ftorafur administration. Alternate schedules of ftorafur should be explored since there appears to be little advantage of a daily ftorafur schedule over conventional 5-FU infusions.
Assuntos
Neoplasias do Colo/tratamento farmacológico , Fluoruracila/análogos & derivados , Mitomicinas/uso terapêutico , Compostos de Nitrosoureia/uso terapêutico , Neoplasias Retais/tratamento farmacológico , Semustina/uso terapêutico , Tegafur/uso terapêutico , Adenocarcinoma/tratamento farmacológico , Adulto , Idoso , Ensaios Clínicos como Assunto , Avaliação de Medicamentos , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Mitomicinas/administração & dosagem , Mitomicinas/efeitos adversos , Semustina/administração & dosagem , Semustina/efeitos adversos , Tegafur/administração & dosagem , Tegafur/efeitos adversosRESUMO
One hundred and thirty-two previously untreated patients with metastatic adenocarcinoma of the gastrointestinal (GI) tract were randomized to receive either a 120-hr infusion of 5-fluorouracil (5FU) with mitomycin-C or mitomycin-C alone. Superiority of the combination treatment was demonstrated with remissions in 30 out of 82 (37%) patients versus 9 out of 50 (18%) with the single drug treatment (P = 0.02). The median survial with 5FU--mitomycin-C was 29 weeks, as opposed to 20 weeks with mitomycin-C alone (P = 0.03). The combination produced significantly more severe myelotoxicity than the single drug, and jaundiced patients experienced more myelosuppression than non-jaundiced patients with both treatments.