ALL R3: mitoxantrone versus idarubicin in first relapse of childhood acute lymphoblastic leukaemia
Children whose leukaemia had come back were far more likely to survive without further relapse if their first block of treatment used mitoxantrone instead of idarubicin, an unexpected finding that changed the standard reinduction treatment.
Overview
Open-label randomised trial in 22 centres in the United Kingdom and Ireland and nine in Australia and New Zealand: 216 of 239 registered children aged 1 to 18 with first relapse of acute lymphoblastic leukaemia were randomised to idarubicin or mitoxantrone during induction, with later chemotherapy or transplant decided by risk group and measurable residual disease.
Three-year progression-free survival was 64.6 percent with mitoxantrone against 35.9 percent with idarubicin (p 0.0004), and three-year overall survival 69.0 against 45.2 percent (p 0.004). The difference came from fewer disease events rather than fewer treatment-related deaths.
- Three-year progression-free survival 64.6 percent (95% CI 54.2 to 73.2) with mitoxantrone versus 35.9 percent (25.9 to 45.9) with idarubicin (p 0.0004).
- Three-year overall survival 69.0 versus 45.2 percent (p 0.004).
- Disease events reduced (hazard ratio 0.56, 95% CI 0.34 to 0.92) without an increase in adverse treatment effects.
Mitoxantrone-based reinduction became the reference treatment for relapsed childhood ALL and the control arm of later international relapse trials.
- The randomisation stopped early after the unexpected difference, with 212 patients analysed.
- The mechanism of mitoxantrone's advantage is not established.
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