Clinical

Doxorubicin not needed for standard-risk hepatoblastoma

Last Updated: 2009-10-21 18:12:39 -0400 (Reuters Health)

NEW YORK (Reuters Health) - Adding doxorubicin to cisplatin for standard-risk hepatoblastoma does not improve resection rates or survival in children with the disease, according to findings from the third study of the International Childhood Liver Tumor Strategy Group (SIOPEL 3).

In the current trial, Dr. Giorgio Perilongo, from the University Hospital of Padua, Italy, and colleagues studied 255 children who received one cycle of cisplatin before being randomized to receive the drug alone (every 14 days) or combined with doxorubicin given in three preoperative and two postoperative cycles.

The primary outcome -- the rate of complete resection -- was not significantly different between the groups: 95% in the cisplatin-only group vs. 93% in the combined drug group, according to the report in The New England Journal of Medicine for October 22.

Likewise, 3-year event-free and overall survival rates with cisplatin alone, 83% and 95%, respectively, were comparable to those seen with cisplatin plus doxorubicin, 85% and 93%, respectively.

Not only did combination therapy not improve survival or resectability, it also resulted in more side effects, as might be expected. Acute grade 3 or 4 adverse events were seen in 20.6% of patients given cisplatin alone versus 74.4% of those given both drugs.

The results, the authors conclude, indicate that "doxorubicin can be safely omitted from the treatment of standard-risk hepatoblastoma."

N Engl J Med 2009;361:1662-1670.