Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial

摘要: Summary Background On the basis of promising results that were reported in several phase 2 trials, we investigated whether addition monoclonal antibody rituximab to first-line chemotherapy with fludarabine and cyclophosphamide would improve outcome patients chronic lymphocytic leukaemia. Methods Treatment-naive, physically fit (aged 30–81 years) CD20-positive leukaemia randomly assigned a one-to-one ratio receive six courses intravenous (25 mg/m per day) (250 for first 3 days each 28-day treatment course or without (375 on day 0 course, 500 1 second sixth courses) 190 centres 11 countries. Investigators not masked computer-generated assignment. The primary endpoint was progression-free survival (PFS). Analysis by intention treat. This study is registered ClinicalTrials.gov, number NCT00281918. Findings 408 fludarabine, cyclophosphamide, (chemoimmunotherapy group) 409 (chemotherapy group); all analysed. At years after randomisation, 65% chemoimmunotherapy group free progression compared 45% (hazard 0·56 [95% CI 0·46–0·69], p vs 83 [21%] 396; 48 [12%]; Interpretation Chemoimmunotherapy improves overall Moreover, suggest choice specific changes natural Funding F Hoffmann-La Roche.