CLL12: ibrutinib in early-stage chronic lymphocytic leukaemia, a randomised placebo-controlled phase 3 trial
Giving the pill ibrutinib to people with early, symptom-free chronic lymphocytic leukaemia delayed the disease but, after almost six years, did not help them live longer than placebo, so doctors should keep watching and waiting rather than treating early.
Overview
Final analysis of the German CLL Study Group's randomised, double-blind, placebo-controlled phase 3 CLL12 trial: 363 patients with asymptomatic, treatment-naive Binet stage A chronic lymphocytic leukaemia at increased risk of progression received ibrutinib 420 mg daily (n 182) or placebo (n 181); 152 low-risk patients were followed on watch and wait.
Ibrutinib significantly delayed progression to symptomatic disease, but at a median observation of 69.3 months five-year survival was 93.3 percent with ibrutinib, 93.6 percent with placebo and 97.9 percent on watch and wait. Adverse events occurred in almost every patient in both groups, with more cardiovascular toxicity on ibrutinib.
- Ibrutinib significantly delayed progression to symptomatic disease compared with placebo.
- Five-year overall survival 93.3 percent (ibrutinib), 93.6 percent (placebo) and 97.9 percent (watch and wait).
- Estimated ten-year survival from diagnosis 89.8, 86.5 and 95.3 percent respectively; increased cardiovascular toxicity with ibrutinib.
Watch and wait remains the standard of care for early-stage chronic lymphocytic leukaemia irrespective of risk factors, even with a targeted drug available.
- Few deaths and long survival mean the trial could not exclude a small survival effect.
- Ibrutinib was given as continuous single-agent therapy; time-limited combinations were not tested.
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