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Cisplatin versus cisplatin plus doxorubicin for standard-risk hepatoblastoma
New England Journal of Medicine, 10/22/09

Perilongo G et al. – As compared with cisplatin plus doxorubicin, cisplatin monotherapy achieved similar rates of complete resection and survival among children with standard-risk hepatoblastoma. Doxorubicin can be safely omitted from the treatment of standard-risk hepatoblastoma.E

Methods

Children with standard-risk hepatoblastoma who were younger than 16 years of age eligible for inclusion in study
After 1 cycle of cisplatin (80 mg per square meter of body-surface area per 24 hours), randomly assigned patients to receive cisplatin (every 14 days) or cisplatin plus doxorubicin administered in 3 preoperative cycles and 2 postoperative cycles
primary outcome was the rate of complete resection, and the trial was powered to test the noninferiority of cisplatin alone

Results

126 patients randomly assigned to receive cisplatin and 129 were randomly assigned to receive cisplatin plus doxorubicin
Rate of complete resection 95% in cisplatin-alone group and 93% in cisplatin–doxorubicin group in intention-to-treat analysis (difference, 1.4%; 95% confidence interval [CI], –4.1 to 7.0); these rates were 99% and 95%, respectively
3-y event-free survival and overall survival were, respectively, 83% (95% CI, 77 to 90) and 95% (95% CI, 91 to 99) in cisplatin group, and 85% (95% CI, 79 to 92) and 93% (95% CI, 88 to 98) in cisplatin–doxorubicin group (median follow-up, 46 months)
Acute grade 3 or 4 adverse events more frequent with combination therapy

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