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Combination regimen did not improve survival in low-grade glioma in children

Issue: July 25, 2012

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The use of a combination of thioguanine, procarbazine, lomustine and vincristine did not increase event-free survival compared with carboplatin and vincristine alone in children with low-grade gliomas, according to the results of a Children’s Oncology Group study.

The study included children aged 10 years or younger with progressive or residual low-grade gliomas. The patients were randomly assigned to either carboplatin and vincristine (CV; n=137) or thioguanine, procarbazine, lomustine and vincristine (TPCV; n=137). Of all enrolled patients, 151 had treatment failure and 38 died.

According to the stratified log-rank test, there was no statistically significant difference in event-free survival between the two treatment groups, with a 39% event-free survival for the CV regimen vs. 52% for the TPCV regimen (P=.1).

On the basis of the cure model analysis, TPCV did confer a higher 5-year event-free survival when compared with CV (P=.025). However, the researchers cautioned that cure model analysis was a data-driven analysis and “should be viewed with some skepticism, since one is testing for the difference that one sees without having a prior expectation that it would exist.”

The researchers identified age and tumor size as independent predictors of worse event-free survival. Specifically, patients aged younger than 1 year had a 3.4 times increased risk for progression compared with patients who were 5 years or older. Those patients with tumors smaller than 3 cm² had a 0.65 times lower risk for progression than those patients with larger tumors.

Despite the negative results of the study, the researchers suggested further exploration of stratification of patients by biologic markers.

“To provide this biologic information, tumor biopsy, when feasible, will be important to future studies since new potentially prognostic genetic abnormalities, such as IDH and BRAF, that were not known at the time of our study have been identified,” the researchers wrote.