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The CALGB 10403 regimen in AYA patients with ALL: A real-world retrospective cohort study
The phase II prospective Cancer and Leukemia Group B (CALGB) 10403 trial (NCT00558519) demonstrated excellent outcomes in adolescent and young adult (AYA) patients with acute lymphoblastic leukemia (ALL), leading to significant change in clinical practice. However, high rates of protocol non-completion and Grade 3–4 asparaginase-related adverse events highlighted the challenges in administering the CALGB 10403 regimen in this population. A real-world retrospective cohort study evaluated the efficacy and safety of the CALGB 10403 regimen in AYA patients with B-cell or T-cell Philadelphia-negative ALL. The results were published by DaSilva et al. in Blood Neoplasia. The study cohort included 139 AYA patients who received the CALGB 10403 regimen between October 2012 and June 2020. The primary endpoints were induction response rate, 3-year event-free survival, and overall survival. The median follow-up was 72 months (range, 5–127 months).
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Key learnings |
The CR/CRi rate by the end of induction was 88% (122/139). Among patients achieving CR/CRi, 58% (108/122) achieved MRD-negative remission by FC and/or NGS. Maintenance chemotherapy was completed by 35% of patients. |
The 3-year EFS and OS rates were 66% (95% CI, 55–74) and 81% (95% CI, 74–87), respectively. Inferior EFS was associated with Hispanic ethnicity (HR, 2.00; p = 0.03), B-ALL (HR, 2.45; p = 0.03), and Ph-like genetics (HR, 3.05; p = 0.014). |
ALT elevation (22%), sepsis (14%), and bilirubin elevation (12%) were the most common Grade 3 or 4 AEs during induction, while ALT elevation (36%), AST elevation (20%), and sepsis (17%) were the most common Grade 3 or 4 AEs post-remission. |
The CALGB 10403 regimen showed comparable efficacy and safety in the real world compared with the clinical trial. Completion of maintenance therapy remained low, warranting further research to improve outcomes and regimen tolerability in AYA patients. |
AE, adverse event; ALL, acute lymphoblastic leukemia; ALT, alanine aminotransferase; AST, aspartate aminotransferase; AYA, adolescent and young adult; B-ALL, B-cell ALL; CALGB, Cancer and Leukemia Group B; CI, confidence interval; CR, complete remission; CRi, complete remission with incomplete blood count recovery; EFS, event-free survival; FC, flow cytometry; HR, hazard ratio; MRD, measurable residual disease; NGS, next-generation sequencing; OS, overall survival; Ph-like, Philadelphia chromosome-like.
References
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