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Outcomes in patients with first-relapsed childhood ALL in Japan: Results from the JPLSG-ALL-R08 study
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The JPLSG-ALL-R08 study was a two-part, prospective multicenter study of first-relapsed patients with childhood ALL.1 The ALL-R08-I part (UMIN000002026; n = 82) was a prospective observational study assessing outcomes of first-relapsed patients with childhood ALL in Japan. The second part, ALL-R08-II (UMIN000002025; n = 77), was a phase II trial assessing the efficacy and safety of ALL-REZ BFM-type treatment in patients with intermediate-risk first-relapsed ALL. Patients in ALL-R08-II with an unsatisfactory MRD response post-induction received allo-HSCT. Patients were risk-stratified according to the BFM-S risk stratification. Results from this study were published in Pediatric Blood & Cancer by Yamanaka et al.1 |
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In the ALL-R08-I cohort, among patients classified as S1 (standard-risk group), S2 (intermediate-risk group), S3 and S4 (high-risk groups), and post-HSCT, the 3-year probability of EFS was 83%, 37%, 28%, 14%, and 0%, respectively, and the 3-year probability of OS was 100%, 73%, 53%, 27%, and 0%, respectively. |
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In the ALL-R08-II cohort, the 3-year EFS and OS rates were 65% and 83%, respectively. The 3-year EFS rates were 70% vs 68% (p = 0.591) and 3-year OS rates were 93% vs 87% (p = 0.731) in MRD-negative (<10−3) and MRD-positive patients (≥10−3), respectively. These findings suggest that selecting patients for allo-HSCT based on post-induction MRD response can improve outcomes. |
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This study confirms the efficacy of ALL-REZ BFM-type treatment in pediatric patients with relapsed ALL in Japan and reinforces the utility of MRD assessment in guiding treatment decisions. The results of the ALL-R08 study can serve as a historical control for future trials of novel agents for pediatric patients with relapsed ALL in Japan. |
Abbreviations: ALL, acute lymphoblastic leukemia; ALL-REZ BFM, Acute Lymphoblastic Leukemia Relapse Study of Berlin–Frankfurt–Münster; allo-HSCT, allogeneic hematopoietic stem cell transplantation; EFS, event-free survival; JPLSG, Japanese Pediatric Leukemia/Lymphoma Study Group; MRD, measurable residual disease; OS, overall survival.
- Yamanaka J, Ogawa C, Arakawa A, et al. Outcomes in children with first-relapsed acute lymphoblastic leukemia in Japan: Results from JCCG Study JPLSG-ALL-R08. Pediatr Blood Cancer. Online ahead of print. DOI: 10.1002/pbc.31319
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