RITUXAN + FC SIGNIFICANTLY PROLONGED PFS IN FIRST-LINE CLL 1

*Patients received fludarabine 25 mg/m2/day and cyclophosphamide 250 mg/m2/day on days 1, 2, and 3 of each cycle, with or without RITUXAN.

RITUXAN + FC SIGNIFICANTLY IMPROVED MEDIAN PFS (N=817) 1

As defined in 1996 National Cancer Institute Working Group guidelines.

  • RITUXAN + FC provided a median PFS of 39.8 months vs 31.5 months for FC in first-line CLL (P<0.01) 1
  • The dose of RITUXAN is 375 mg/m2 IV infusion the day prior to the initiation of FC chemotherapy, then 500 mg/m2 on Day 1 of cycles 2−6 (every 28 days)

CLL8 TREATMENT CONSIDERATIONS

The CLL8 trial was not designed or powered to detect a significant difference in PFS by age category. However, exploratory analysis defined by age suggests no observed benefit with the addition of RITUXAN to FC chemotherapy in previously untreated CLL patients 70 years of age or older.

SELECT IMPORTANT SAFETY INFORMATION

RITUXAN IN COMBINATION WITH FC FOR PREVIOUSLY UNTREATED CLL

  • In the CLL8 study of patients with previously untreated CLL, detailed safety data collection was limited to Grade 3 and 4 adverse reactions and serious adverse reactions
  • Grade 3 or 4 adverse reactions that occurred more frequently in patients treated with R-FC vs. FC were infusion reactions (9% in the R-FC arm), neutropenia (30% vs. 19%), febrile neutropenia (9% vs. 6%), leukopenia (23% vs. 12%), and pancytopenia (3% vs. 1%)
  • The frequency of prolonged neutropenia for patients who received R-FC vs. FC was 8.5% and 5.8% respectively. For patients who did not have prolonged neutropenia, the frequency of late-onset neutropenia for patients who received R-FC vs. FC was 14.8% and 4.3%, respectively
  • Grade 3 or 4 adverse reactions that occurred more frequently in R-FC-treated patients ≥70 years of age compared to younger patients were neutropenia (44% vs. 31%), febrile neutropenia (16% vs. 6%), pancytopenia (7% vs. 2%), and anemia (5% vs. 2%)

CLL=chronic lymphocytic leukemia; FC=fludarabine and cyclophosphamide; PFS=progression-free survival; R=RITUXAN; CI=confidence interval.

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