RITUXAN + FC PROVIDED SIGNIFICANT INCREASE IN PFS IN PREVIOUSLY TREATED PATIENTS 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=552) 1

As defined in 1996 National Cancer Institute Working Group guidelines.

  • RITUXAN + FC provided a median PFS of 26.7 months vs 21.7 months for FC in previously treated CLL (P=0.02) 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)

REACH TREATMENT CONSIDERATIONS

The REACH 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 treated CLL patients 65 years of age or older.

SELECT IMPORTANT SAFETY INFORMATION

RITUXAN IN COMBINATION WITH FC FOR PREVIOUSLY TREATED CLL

  • Grade 3 or 4 adverse reactions that occurred more frequently in patients treated with R-FC vs. FC were infusion reactions (7% in R-FC arm), neutropenia (49% vs. 44%), febrile neutropenia (15% vs. 12%), thrombocytopenia (11% vs. 9%), hypotension (2% vs. 0%), and hepatitis B (2% vs. <1%)
  • The frequency of prolonged neutropenia for patients who received R-FC vs. FC was 24.8% and 19.1% respectively. For patients who did not have prolonged neutropenia, the frequency of late-onset neutropenia for patients who received R-FC vs. FC was 38.7% and 13.6%, 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 (56% vs. 39%), infections (30% vs. 14%), anemia (21% vs. 10%), thrombocytopenia (19% vs. 8%), and pancytopenia (7% vs. 2%)
  • Fifty-nine percent of R-FC–treated patients experienced an infusion reaction

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

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