Table 17:
Outcome | Augmented Group,% (95% Cl) | Standard Group,% (95% Cl) | Risk of Event in Augmented Group, Odds Ratioa (95% Cl) | P |
---|---|---|---|---|
5-year EFSb | 89.6 (85.9–93.3) | 82.2 (78.1–87.5) | 0.61b (0.39–0.98) | .04 |
5-year OSc | 92.9 (89.9–96.0) | 88.9 (85.0–92.8) | 0.67c (0.38–1.17) | .16 |
5-year relapse | 7.5 (4.2–10.8) | 14.2 (9.7–18.7) | 0.55 (0.33–0.94) | .03 |
Abbreviations: ALL, acute lymphoblastic leukemia; Cl, confidence interval; EFS, event-free survival; MRD-HR, minimal residual disease–high risk; OS, overall survival.
Unadjusted odds ratio for augmented group; separate analysis accounting for the variables on which randomization was balanced: age (< 10 years vs. ≥10 years), sex (male vs. female), and white blood cell count at diagnosis (< 50 × 109/L vs. ≥ 50 × 109/L) did not yield materially different results.
Events included relapse, secondary tumour, or death.
Event defined as any death.
Source: Vora et al, 2014.68