RESUMO
A randomized study was conducted to determine the effect of cyclophosphamide on the rate of recurrence and metastases in children with localized and regional neuroblastoma. One hundred and thirty-four patients were entered and 113 were suitable for analysis. All patients had surgical resection of the primary tumor when possible, postoperative irradiation to the tumor bed when indicated for gross residual disease, and 49/113 received cyclophosphamide, 10 mg/kg/day orally for 7-10 days every 28 days for 1 year. A difference was found in the rate of metastases between the patients who did and did not receive chemotherapy; the overall survival of about 80% in both groups was better than anticipated. All relapses occurred during the first year; there were none in 27 Stage I patients, 8/52 in Stage II and 13/34 in Stage III. Toxicity was minimal, with only two patients developing hemorrhagic cystitis that prevented continued therapy.
Assuntos
Ciclofosfamida/uso terapêutico , Neuroblastoma/tratamento farmacológico , Pré-Escolar , Ensaios Clínicos como Assunto , Ciclofosfamida/efeitos adversos , Humanos , Lactente , Recém-Nascido , Metástase Neoplásica , Recidiva Local de Neoplasia , Neuroblastoma/patologia , Fatores de TempoRESUMO
A randomized study was designed to determine the effect of intermittent oral cyclophosphamide on the rate of metastases in children with localized and regional neuroblastoma. Secondary objectives of the study were to determine the value of the proposed staging system, to measure the influence of the peripheral lymphocyte count on prognosis, and to study the effect of the primary tumor site and regional node involvement. Since there was no difference in survival in the two groups of patients, whether or not they received chemotherapy, all 113 children were treated as a single group for the analysis of the secondary objectives. The proposed staging served as a good indicator of prognosis with a significant difference in survival seen between each of three stages. It was not possible to detect a significant influence by the three other prognostic variables studied, peripheral lymphocytes, primary site and regional node involvement. Small numbers in the various subgroups studied may account for the failure of differences to achieve statistical significance.
