Single-doseversus fractionated-dose dactinomycin in the treatment of wilms' tumor. Preliminary results of a clinical trial

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Abstract
A clinical trial was conducted by the Brazilian Wilms' Tumor (WT) Study Group to compare the single‐dose (60 μ/kg × 1 day) administration of dactinomycin (AMD) with the standard fractionated dose (15 μ/kg/d × 5 days) used in the US National WT Study. Except for the AMD administration, treatment for all patients followed that of the latter study. Patients were randomized to receive either of the two AMD regimens in the schedules most appropriate for their stage and histologic condition. One hundred seventy‐six children with WT entered the study until December 1988. No significant differences in overall or relapse‐free survival distributions were observed between treatment arms using data for all patients or data stratified by disease stage. Two‐year survival rates were 83.0% and 85.3% for patients receiving the fractionated and single doses of AMD, respectively. Survival distributions could also be compared once patients with protocol violations were excluded. The overall 2‐year survival rates were 89.7% and 88.6% and the relapse‐free 2‐year survival rates were 78.2% and 76.1% for the fractionated and single AMD doses, respectively. Altered liver function was seen in three patients who received the fractionated dose and in four patients who received the single AMD dose. Acute toxicity was observed in only one patient of the fractionated‐dose group and in zero of the patients of the single‐dose group. At the closing date, patients assigned to the simplified AMD regimen had accumulated 1840 days less of hospital stay than those treated by the standard regimen.