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A previous Children’s Oncology Group (COG) trial AALL07P1 (NCT00873093[MM1] ) demonstrated the efficacy of bortezomib in treating patients with T-cell acute lymphoblastic leukemia (T-ALL) and lymphoblastic lymphoma (T-LL).1 The objectives of the phase III COG AALL1231 trial (NCT02112916) reported by Teachey, et al., in the Journal of Clinical Oncology, were to further investigate the use of bortezomib in treating children and young adults with T-ALL/T-LL and evaluate reduced use of prophylactic cranial radiation therapy (CRT) in newly diagnosed T-ALL.2 Use of CRT, which is current standard of care, causes significant long-term problems, including secondary cancers, irreversible endocrinopathies, neurocognitive decline, and neurotoxic effects. Patients were randomly assigned to a modified Berlin-Frankfurt-Münster (BFM) chemotherapy regimen with/without bortezomib during induction and delayed intensification. Modifications to the BFM backbone, used in the predecessor COG AALL0434 trial (NCT00408005)3, included a substitution of dexamethasone instead of prednisone and the addition of two extra doses of pegaspargase.
AALL1231 demonstrated that the proteosome inhibitor bortezomib improved EFS and OS in patients with T-LL, but not T-ALL, when combined with modified augmented BFM chemotherapy. In addition, it was shown that CRT can be safely and effectively eliminated in ≥90% of patients with T-ALL, without intensifying systemic chemotherapy. These data indicate that incorporating bortezomib into standard of care therapy for newly diagnosed T-LL appears to be advantageous. It is hoped that future trials will build on these positive findings to enable high cure rates without routine CRT.
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