Children's Oncology Group Trial AALL1231: A Phase III Clinical Trial Testing Bortezomib in Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia and Lymphoma.
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Teachey David T, Devidas Meenakshi, Wood Brent L, Chen Zhiguo, Hayashi Robert J, Hermiston Michelle L, Annett Robert D, Archer J Hunter, Asselin Barbara L, August Keith J, Cho Steve Y, Dunsmore Kimberly P, Fisher Brian T, Freedman Jason L, Galardy Paul J, Harker-Murray Paul, Horton Terzah M, Jaju Alok I, Lam Allison, Messinger Yoav H, Miles Rodney R, Okada Maki, Patel Samir I, Schafer Eric S, Schechter Tal, Singh Neelam, Steele Amii C, Sulis Maria Luisa, Vargas Sarah L, Winter Stuart S, Wood Charlotte, Zweidler-McKay Patrick, Bollard Catherine M, Loh Mignon L, Hunger Stephen P, Raetz Elizabeth A
Аннотация
PATIENTS AND METHODS: Children and young adults with T-ALL/T-LL were randomly assigned to a modified augmented Berlin-Frankfurt-Münster chemotherapy regimen with/without bortezomib during induction and delayed intensification. Multiple modifications were made to the augmented Berlin-Frankfurt-Münster backbone used in the predecessor trial, AALL0434, including using dexamethasone instead of prednisone and adding two extra doses of pegaspargase in an attempt to eliminate CRT in most patients.
RESULTS: AALL1231 accrued 824 eligible and evaluable patients from 2014 to 2017. The 4-year event-free survival (EFS) and overall survival (OS) for arm A (no bortezomib) versus arm B (bortezomib) were 80.1% ± 2.3% versus 83.8% ± 2.1% (EFS, P = .131) and 85.7% ± 2.0% versus 88.3% ± 1.8% (OS, P = .085). Patients with T-LL had improved EFS and OS with bortezomib: 4-year EFS (76.5% ± 5.1% v 86.4% ± 4.0%; P = .041); and 4-year OS (78.3% ± 4.9% v 89.5% ± 3.6%; P = .009). No excess toxicity was seen with bortezomib. In AALL0434, 90.8% of patients with T-ALL received CRT. In AALL1231, 9.5% of patients were scheduled to receive CRT. Evaluation of comparable AALL0434 patients who received CRT and AALL1231 patients who did not receive CRT demonstrated no statistical differences in EFS (P = .412) and OS (P = .600).
CONCLUSION: Patients with T-LL had significantly improved EFS and OS with bortezomib on the AALL1231 backbone. Systemic therapy intensification allowed elimination of CRT in more than 90% of patients with T-ALL without excess relapse.