IN FIRST-LINE LOW-GRADE LYMPHOMA PATIENTS WHO DID NOT PROGRESS FOLLOWING CVP

ECOG 1496: A PROVEN POST-INDUCTION DOSING STRATEGY FOR FIRST-LINE LOW-GRADE LYMPHOMA

ECOG 1496 TRIAL DESIGN 1,2,6

*Cyclophosphamide was dosed at 1 g/m2 on Day 1; vincristine 1.4 mg/m2 on Day 1; prednisone 100 mg/m2 on Days 1–5. After the completion of six to eight 21–day cycles of CVP, patients achieving CR, PR, or SD were randomized to receive no further treatment or to receive post-induction therapy with RITUXAN. Beginning 4 weeks after completion of induction therapy, patients randomized to RITUXAN received 1 cycle of 4 weekly treatments with 375 mg/m2 RITUXAN, every 6 months for up to 4 cycles. 6

THE ECOG 1496 DOSING STRATEGY IS BASED ON B-CELL DEPLETION AND RECOVERY

B-CELL DEPLETION AFTER RITUXAN MONOTHERAPY IN THE MCLAUGHLIN TRIAL 3

In The McLaughlin Monotherapy Trial In Relapsed Or Refractory, Follicular Or Low-Grade NHL 3:
  • RITUXAN 375 mg/m2 was administered once weekly for 4 weeks
  • B cells were rapidly depleted after 4 doses of RITUXAN
  • Recovery began at 6 months and patients returned to baseline levels by 12 months after completion of a 4-week course of RITUXAN monotherapy

SELECT IMPORTANT SAFETY INFORMATION
SINGLE-AGENT RITUXAN FOR LOW-GRADE NHL AFTER FIRST-LINE CVP CHEMOTHERAPY

  • Neutropenia was the only Grade 3 or 4 adverse reaction that occurred more frequently (≥2%) in the RITUXAN arm compared with those who received no further therapy (4% vs. 1%)
  • The following common adverse reactions were reported more frequently (≥5%) in patients receiving RITUXAN following CVP compared with those who received no further therapy: fatigue (39% vs. 14%), anemia (35% vs. 20%), peripheral sensory neuropathy (30% vs. 18%), infections (19% vs. 9%), pulmonary toxicity (18% vs. 10%), hepatobiliary toxicity (17% vs. 7%), rash and/or pruritus (17% vs. 5%), arthralgia (12% vs. 3%), and weight gain (11% vs. 4%)

CVP=cyclophosphamide, vincristine, prednisone; ECOG=Eastern Cooperative Oncology Group; NHL=non-Hodgkin's lymphoma; IWF=International Working Formulation; IPI=International Prognostic Index; LDH=lactate dehydrogenase; PS=performance status; CR=complete response; PR=partial response; SD=stable disease; PFS=progression-free survival.

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