RITUXAN MONOTHERAPY DELIVERED DURABLE RESPONSES IN RELAPSED OR REFRACTORY, LOW-GRADE OR FOLLICULAR NHL

DURATION OF RESPONSE IN HEAVILY PRETREATED PATIENTS WITH LOW-GRADE OR FOLLICULAR NHL 1,2,3,10,11

*A multicenter, open-label, single-arm study was conducted in 166 patients with relapsed or refractory, low-grade or follicular, B-cell NHL who received 375 mg/m2 of RITUXAN given as an intravenous infusion weekly for 4 doses. Patients with tumor masses > 10 cm or with > 5000 lymphocytes/µL in the peripheral blood were excluded from the study. The median time to onset of response was 50 days.

In a multicenter, single-arm study, 37 patients with relapsed or refractory, low-grade NHL received 375 mg/m2 of RITUXAN weekly for 8 doses.

In a multicenter, single-arm study, 60 patients received 375 mg/m2 of RITUXAN weekly for 4 doses. All patients had relapsed or refractory, low-grade or follicular, B-cell NHL and had achieved an objective clinical response to RITUXAN administered 3.8−35.6 months (median 14.5 months) prior to retreatment with RITUXAN. Of these 60 patients, 5 received more than one additional course of RITUXAN.

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SINGLE-AGENT RITUXAN FOR RELAPSED OR REFRACTORY, LOW-GRADE OR FOLLICULAR NHL

  • Grade 3 and 4 cytopenias were reported in 48% of patients and included lymphopenia (40%), neutropenia (6%), leukopenia (4%), anemia (3%), and thrombocytopenia (2%). Serious Grade 3 or 4 infections, including sepsis, occurred in <5% of patients
  • The overall incidence of infections was 31%: bacterial (19%), viral (10%), unknown (6%), and fungal (1%)

NHL=non-Hodgkin's lymphoma; ITT=intent to treat.

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