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Rituximab, fludarabine and cyclophosphamide combo prolonged progression-free survival in relapsed or refractory CLL
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50th ASH Annual Meeting
Results from the phase-3 REACH BO17072 study have shown that treating patients with chronic lymphocytic leukemia with the combination of rituximab, fludarabine and cyclophosphamide improved progression-free survival by 10 months compared to treatment with fludarabine and cyclophosphamide alone. Complete response rates in patients with relapsed or refractory CLL almost doubled with RFC compared with FC.
In the late-breaking trial, 552 patients with relapsed or refractory CLL were randomized to receive six 28-day cycles of fludarabine (25 mg/m2 intravenously on days one to three) and cyclophosphamide (250 mg/m2 intravenously on days one to three) alone or in combination with rituximab (375 mg/m2 intravenously at the start of first cycle and 500 mg/m2 on day one for all subsequent cycles). The primary endpoint of the study was progression-free survival. On average, patients had received one prior treatment regimen: 66% had received a single-agent alkylator therapy, 16% a purine analog therapy, and 18% combination chemotherapy treatments.
Patients in the FCR arm had an average 30.6 months progression-free survival vs. 20.6 months in the FC arm (P=.0002). The overall response rate was significantly higher in the FCR arm compared with the FC arm (69.9% vs. 58%; P=.0034), due to superior complete response rates in the FCR arm (24.3% vs. 13%; P=.0007).
Grade 3 and 4 adverse events were more prevalent in the FCR arm vs. the FC arm (80% vs. 74%); serious adverse events were similar in each arm (50% vs. 48%). – by Evan Young
For more information:
- Robak T. LBA1. Presented at: 50th Annual Meeting of the American Society of Hematology; December 5-9, 2008; San Francisco.