AALL1331: blinatumomab added to chemotherapy in low-risk first relapse of childhood B-ALL
In children with a late, low-risk relapse of leukaemia, adding three blocks of blinatumomab did not change survival overall, but for the two thirds whose relapse involved the bone marrow it cut relapses and deaths enough to become their new standard.
Overview
Report of the low-risk stratum of the Children's Oncology Group AALL1331 trial: 255 patients aged 1 to 30 with low-risk first relapse of B-cell acute lymphoblastic leukaemia were randomised after reinduction to standard chemotherapy or chemotherapy with three blinatumomab blocks intercalated.
Four-year disease-free and overall survival were 61.2 and 90.4 percent with blinatumomab against 49.5 and 79.6 percent with chemotherapy (p 0.089 and 0.11). For the 174 patients with bone marrow relapse (with or without extramedullary disease) the differences were significant (disease-free survival 72.7 against 53.7 percent, overall survival 97.1 against 84.8 percent), while the 81 patients with isolated extramedullary relapse did poorly in both arms.
- Four-year disease-free survival 61.2 versus 49.5 percent and overall survival 90.4 versus 79.6 percent overall (not significant).
- Bone marrow relapse: four-year disease-free survival 72.7 versus 53.7 percent (p 0.015) and overall survival 97.1 versus 84.8 percent (p 0.020).
- Isolated extramedullary relapse: no difference, with four-year disease-free survival under 40 percent in both arms.
Blinatumomab belongs in the treatment of low-risk marrow relapse in children; isolated extramedullary relapse needs new approaches.
- The overall comparison was not statistically significant; the marrow-relapse benefit is a subgroup finding.
- Patients with central nervous system leukaemia received cranial radiotherapy in both arms.
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