AFTER FIRST-LINE TREATMENT OF FOLLICULAR OR LOW-GRADE NON-HODGKIN'S LYMPHOMA (NHL)

2 YEARS OF RITUXAN POST-INDUCTION THERAPY IS A PROACTIVE APPROACH THAT REDUCED THE RISK OF PROGRESSION, RELAPSE, OR DEATH BY NEARLY 50% 1

STUDIED IN MORE THAN 1300 PATIENTS 1

  • In PRIMA, patients were randomized to receive either RITUXAN or no further therapy if they achieved a CR/CRu or PR with R-CHEMO induction therapy 1
  • In ECOG 1496, patients were randomized to receive either RITUXAN or no further therapy if they achieved a CR, PR, or SD with CVP induction therapy 1

*R-CHEMO: Approximately 75% of trial patients in both trial arms received R-CHOP, 22% received R-CVP, and 3% received R-FCM. 1

The risk of progression, relapse, or death for observation arms of the PRIMA and ECOG 1496 trials were calculated using the formula 1/HR.

PRIMA: SELECT IMPORTANT SAFETY INFORMATION

SINGLE-AGENT RITUXAN AS MAINTENANCE FOR FOLLICULAR NHL AFTER FIRST-LINE RITUXAN-BASED CHEMOTHERAPY

  • Detailed safety data collection was limited to Grade ≥2 infections, Grade ≥3 adverse reactions, and serious adverse reactions
  • The most common Grade 3-4 adverse reactions occurring at a higher incidence (≥2%) in the RITUXAN arm than in the observation arm were infections (4% vs. 1%) and neutropenia (4% vs. <1%)
  • The most frequently reported adverse reaction was infections. In patients receiving RITUXAN as single-agent maintenance therapy following RITUXAN plus chemotherapy, infections were reported more frequently compared with the observation arm (37% vs. 22%)

ECOG 1496: 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%)

NHL=non-Hodgkin's lymphoma; HR=hazard ratio; CI=confidence interval; R=RITUXAN; PRIMA=Primary RItuximab and MAintenance; CVP=cyclophosphamide, vincristine, and prednisone; CHOP=cyclophosphamide, doxorubicin, vincristine, and prednisone; FCM=fludarabine, cyclophosphamide, and mitoxantrone; ECOG=Eastern Cooperative Oncology Group; CR=complete response; CRu=complete response, unconfirmed; PR=partial response; SD=stable disease.

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