(HealthDay News) — Treatment of children with newly-diagnosed T-cell acute lymphoblastic leukemia (T-ALL) with nelarabine, in addition to an intensive Berlin-Frankfurt-Münster (BFM) 86-based chemotherapy regimen, is feasible and safe, according to a study published online June 25 in the Journal of Clinical Oncology.
Kimberly P. Dunsmore, MD, of the University of Virginia Health System in Charlottesville, and colleagues conducted a study involving children with newly-diagnosed T-ALL to assess the feasibility and safety of adding nelarabine to a chemotherapy regimen. In stage one, 12 participants with a slow early response (SER) received chemotherapy plus nelarabine and 16 patients with a rapid early response (RER) received chemotherapy without nelarabine. In stage two, 10 patients with SER received six five-day courses of nelarabine, while 12 SER and 38 RER patients received nelarabine once daily.
The researchers found that nelarabine-treated patients exhibited fewer neutropenic infections compared with non-nelarabine-treated patients (42% vs. 81%). Five-year event-free survival (EFS) for patients with SER was 73% for 11 stage-one patients treated with nelarabine and 67% for 22 patients treated with nelarabine. For RER patients, the five-year EFS was 69% for 16 stage-one patients treated without nelarabine and 74% for 38 patients treated with nelarabine. For all 70 patients receiving nelarabine, the five-year EFS was 73%, compared with 69% for the 16 patients treated without nelarabine.
“Addition of nelarabine to a BFM 86-based chemotherapy regimen was well tolerated and produced encouraging results in pediatric patients with T-ALL, particularly those with a SER, who have historically fared poorly,” the authors write.
One author disclosed financial ties to Becton-Dickinson Biosciences. The study was partially funded by GlaxoSmithKline, which provided nelarabine.