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The FORUM trial: Allo-HSCT outcomes in children with high-risk BCP‑ALL
Results from a retrospective analysis of the prospective, open-label, randomized, global phase III FORUM (NCT01949129) study, evaluating post-allogeneic hematopoietic stem cell transplantation (allo-HSCT) outcomes in 741 children with B‑cell precursor acute lymphoblastic leukemia (BCP‑ALL) with high-risk genetic features, were published in Blood by Buechner et al. Patients were stratified by genetic aberration into those who had BCR::ABL1 fusion (BCR::ABL1+; n = 81), hypodiploidy (n = 59), and neither of the two aberrations (n = 601). Key outcomes included overall survival (OS), event-free survival (EFS), cumulative incidence of relapse (CIR), non-relapse mortality (NRM), incidence of acute (a) or chronic (c) graft-versus-host disease (GvHD), Grade 2–4 aGvHD / extensive cGvHD-free relapse-free survival (GRFS), and cumulative incidence of secondary malignancies (SM).
Key data: At a median follow-up of 4.34 years, 3‑year OS rates were 0.86 in the BCR::ABL1+ group (95% confidence interval [CI], 0.76–0.92), 0.79 in the hypodiploid group (95% CI, 0.65–0.87), and 0.79 in the neither group (95% CI, 0.76–0.82). Incidence of aGvHD and cGvHD did not significantly differ between groups. Among patients who received total body irradiation (TBI), 3‑year OS rates were 0.89, 0.77, and 0.85 in the BCR::ABL1+, hypodiploidy, and neither groups, respectively (p = not significant [NS]). Among patients in second complete remission (CR2), OS (p = 0.001) and EFS (p = 0.018) rates were lower in patients with hypodiploidy vs BCR::ABL1+ BCP‑ALL. Tyrosine kinase inhibitor (TKI) use after allo-HSCT significantly improved 3‑year EFS vs preemptive or no TKI use (p = 0.008) and reduced the CIR (p = 0.022) in patients with BCR::ABL1+ BCP‑ALL.
Key learning: Patients with high-risk BCR::ABL1+ or hypodiploid BCP‑ALL enrolled in the FORUM protocol achieved post-allo-HSCT survival outcomes comparable with those without these genetic lesions. Prophylactic TKI therapy following allo-HSCT improved outcomes in BCR::ABL1+ BCP‑ALL, supporting its use after transplantation.
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