Toxic deaths in the Second National Wilms' Tumor Study.

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Abstract
There were 122 deaths among 803 children registered, randomized, and followed in the second National Wilms'' Tumor Study; 17 occurred in children apparently free of disease and were attributable to causes other than tumor progression. Seven deaths were attributed to infection during periods of drug induced leukopenia; 4 were due to liver failure; and 1 each was attributable to radiation pneumonopathy, intestinal obstruction, renal failure, myocardial disease, and encephalopathy. The cause of 1 death was unexplained. Of particular concern were 4 (of 47) infants under 1 yr of age with group I or II disease who had toxic deaths. Subsequent to these experiences the doses of all chemotherapeutic agents vincristine, doxorubicin and dactinomycin were reduced by 50% for infants under 1 yr of age. No deaths from toxicity were observed thereafter in infants. An analysis of the therapeutic effect of this dose reduction showed 3 of 47 relapsed on full dose and 5 of 54 on half dose. The difference is not statistically significant. The potentially serious vulnerability of infants of standard doses of anticancer drugs even when they are calculated on a per kg basis is demonstrated.