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Impact of treatment protocol deviations on outcomes in the ALL-REZ BFM 2002 study
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Significant progress has been made in the treatment of pediatric patients with ALL; however, 15% of patients still relapse.1 While treatment protocols for patients with relapsed ALL are designed to be strictly adhered to, treatment protocol deviations during clinical trials occur regularly, and the prognostic impact of these remains unclear.1 The multicenter, randomized ALL-REZ BFM 2002 trial (NCT00114348) evaluated a risk-adapted combination of chemotherapy, allo-HSCT, and radiotherapy in patients aged <18 years with ALL in first relapse.1 A retrospective analysis assessed the characteristics of protocol deviations and their impact on outcomes in 687 patients treated in the trial. Results from this analysis were published in Leukemia by Argyriadi et al.1 |
| Key learnings |
| In a survival analysis, patients with protocol deviations (n = 94) had a lower probability of 5‐year DFS (38% vs 61%; p < 0.001) and OS (57% vs 70%; p < 0.001) compared to those who were protocol-compliant (n = 509). |
| A time-dependent multivariate analysis revealed that protocol deviation status, time of relapse, and immunologic subtype were independently associated with DFS (p ≤ 0.001). |
| Protocol deviations driven by treatment-related toxicity were associated with a lower 5-year DFS vs no deviations (36% vs 61%; p < 0.001), whereas deviations due to insufficient response did not impact 5-year DFS (49% vs 61%; p = 0.09). |
| These results suggest protocol deviations due to treatment toxicity are associated with inferior outcomes, and highlight the need for less toxic treatments and strict protocol compliance to enhance clinical outcomes in pediatric patients with relapsed ALL. |
Abbreviations: ALL, acute lymphoblastic leukemia; ALL-REZ BFM, Berlin-Frankfurt-Münster Group’s Acute Lymphoblastic Leukemia-Relapse Study; allo-HSCT, allogeneic hematopoietic stem cell transplantation; DFS, disease-free survival; OS, overall survival.
- Argyriadi EA, Steffen IG, Chen-Santel C, et al. Prognostic relevance of treatment deviations in children with relapsed acute lymphoblastic leukemia who were treated in the ALL-REZ BFM 2002 study. Leukemia. 2025;39(2):337-345. DOI: 10.1038/s41375-024-02474-6
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