AALL1231: bortezomib in newly diagnosed T-cell acute lymphoblastic leukaemia and lymphoma, with cranial radiotherapy removed
In children with T-cell leukaemia or lymphoma, adding bortezomib to chemotherapy did not significantly improve survival for the whole group but did for those with lymphoma, and the intensified chemotherapy let more than nine in ten avoid radiotherapy to the brain without more relapses.
Overview
Children's Oncology Group phase 3 trial: 824 eligible children and young adults with T-cell acute lymphoblastic leukaemia or lymphoblastic lymphoma enrolled between 2014 and 2017 were randomised to a modified augmented BFM regimen with or without bortezomib during induction and delayed intensification; the backbone was intensified so that prophylactic cranial radiotherapy was scheduled for only 9.5 percent of patients.
Four-year event-free survival was 80.1 percent without and 83.8 percent with bortezomib (p 0.131); overall survival 85.7 and 88.3 percent (p 0.085). Patients with lymphoblastic lymphoma had significantly better event-free (86.4 against 76.5 percent) and overall survival (89.5 against 78.3 percent) with bortezomib. Patients spared cranial radiotherapy did as well as comparable irradiated patients in the predecessor trial AALL0434.
- Four-year event-free survival 83.8 percent with bortezomib versus 80.1 percent without (p 0.131); overall survival 88.3 versus 85.7 percent (p 0.085).
- T-lymphoblastic lymphoma: four-year event-free survival 86.4 versus 76.5 percent (p 0.041) and overall survival 89.5 versus 78.3 percent (p 0.009).
- Cranial radiotherapy scheduled for 9.5 percent of patients against 90.8 percent in AALL0434, with no difference in event-free or overall survival.
Prophylactic cranial radiotherapy can be limited to central nervous system involvement and the highest-risk patients in childhood T-ALL, and bortezomib is a reasonable addition for T-lymphoblastic lymphoma.
- The primary comparison across all patients was not significant; the lymphoma benefit is a subgroup result.
- Open-label design.
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