RESUMEN
Four patients with advanced or metastatic bladder cancer progressing after MVAC chemotherapy were treated with oral piritrexim. Three of the four patients were evaluable for response, and all three had a partial response to treatment. Piritrexim may be an effective drug for bladder cancer after progression on MVAC chemotherapy.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Pirimidinas/uso terapéutico , Neoplasias de la Vejiga Urinaria/tratamiento farmacológico , Administración Oral , Carcinoma de Células Transicionales/tratamiento farmacológico , Cisplatino/administración & dosificación , Doxorrubicina/administración & dosificación , Femenino , Humanos , Masculino , Metotrexato/administración & dosificación , Persona de Mediana Edad , Pirimidinas/administración & dosificación , Neoplasias de la Vejiga Urinaria/patología , Vinblastina/administración & dosificaciónRESUMEN
PURPOSE: A prospectively randomized trial was performed to determine whether the combination of fluorouracil (FU) plus leucovorin (FU-LV) administered orally is more effective than equitoxic FU for patients with metastatic colorectal cancer. PATIENTS AND METHODS: A double-blind, placebo-controlled trial design was used to eliminate observer bias. An escalating FU dosing schedule was used to achieve equal toxicity. End points were response, time to treatment failure (TTF), and eight quality-of-life (QL) parameters. A crossover arm allowed FU-treated patients to receive FU-LV combination treatment after treatment failure. RESULTS: Response rate was 32% for FU-LV versus 23% for FU (P = .15). Median TTF was 22 versus 16 weeks (P = .27). Median survival time was 44 versus 54 weeks (P = .26). QL was the same for both treatments, except for days of hospitalization, which was greater for FU-LV (P < .001). Toxicities were similar to those previously reported for FU-LV and FU alone. CONCLUSION: Oral LV-FU produces the same efficacy and toxicity pattern as has been reported for intravenous LV-FU. When FU-LV is compared with equitoxic doses of FU, there is no difference in patient outcome. These results suggest that patients with advanced disease should receive FU at doses adequate to produce toxicity.