NHL Retreatment Trial (Davis Retreatment Trial)
RITUXAN use in NHL delivers durable responses as powerful monotherapy
Davis retreatment trial: Prior RITUXAN responders1
Percentages are based on calculations.
*Based on the International Working Formulation.
- Treatment in the trial consisted of RITUXAN 375 mg/m2 IV administered once weekly for a total of 4 infusions
- All patients had received at least 2 prior therapies and responded to at least 1 prior course of RITUXAN
- The median interval between RITUXAN courses was 14.5 months1,2
Davis retreatment protocol1
Adverse reactions in patients receiving single-agent RITUXAN
The most common adverse reactions of RITUXAN (incidence ≥25%) observed in patients with relapsed or refractory, low-grade or follicular NHL were infusion reactions, fever, lymphopenia, chills, infection, and asthenia. Grade 3 and 4 cytopenias were reported in 48% of patients and included lymphopenia (40%), neutropenia (6%), leukopenia (4%), anemia (3%), and thrombocytopenia (2%)2
RITUXAN retreatment led to responses that lasted longer than 1 year1
RITUXAN demonstrated durable responses in heavily pretreated
patients (2 to 11 prior therapies; median of 4)1
- The prescribing information for RITUXAN reports a median duration of response of 15.0 months in retreatment2
Safety summary:
- In RITUXAN clinical trials of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL, the most common Grade 3 or 4 adverse reactions (>1%) observed in patients receiving single-agent RITUXAN (N=356) were lymphopenia (40%), neutropenia (6%), leukopenia (4%), infection (4%), anemia (3%), chills (3%), and thrombocytopenia (2%)2
Significant response rates achieved in retreatment2
Overall response rate
- Nearly 40% of patients who responded to RITUXAN once responded again in retreatment, with 10% of patients achieving a CR2
INDICATIONS AND IMPORTANT SAFETY INFORMATION
RITUXAN® (Rituximab) is indicated for the treatment of patients with:
- Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)
- Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
- Weekly ×4
- Weekly ×8
- Bulky disease
- Retreatment
- Previously untreated follicular, CD20-positive, B-cell NHL in combination with CVP chemotherapy
- Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent, after first-line CVP chemotherapy
- Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens
RITUXAN is not recommended for use in patients with severe, active infections.
WARNING: FATAL INFUSION REACTIONS, TUMOR LYSIS SYNDROME (TLS), SEVERE MUCOCUTANEOUS REACTIONS, and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)
Infusion Reactions: RITUXAN administration can result in serious, including fatal, infusion reactions. Deaths within 24 hours of RITUXAN infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Carefully monitor patients during infusions. Discontinue RITUXAN infusion and provide medical treatment for Grade 3 or 4 infusion reactions.
Tumor Lysis Syndrome (TLS): Acute renal failure requiring dialysis with instances of fatal outcome can occur in the setting of TLS following treatment of non-Hodgkin’s lymphoma (NHL) with RITUXAN monotherapy.
Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving RITUXAN.
Progressive Multifocal Leukoencephalopathy (PML): JC virus infection resulting in PML and death can occur in patients receiving RITUXAN.
RITUXAN has also been associated with other serious and/or fatal adverse reactions. These include hepatitis B reactivation with fulminant hepatitis, other infections, cardiovascular events, renal toxicity, and bowel obstruction and perforation.
The most common adverse reactions of RITUXAN (incidence ≥25%) observed in clinical trials of patients with NHL were infusion reactions, fever, lymphopenia, chills, infection, and asthenia. The incidence of infusion reactions was highest during the first infusion (77%) and decreased with each subsequent infusion. These infusion reactions typically resolved with slowing or interruption of the infusion and with supportive care. The most frequent Grade 3 or 4 adverse reactions observed in NHL were cytopenias.
The most common adverse reactions of RITUXAN (incidence ≥25%) observed in clinical trials of patients with CLL were infusion reactions and neutropenia. Infusion-related adverse reactions occurring during or within 24 hours of the start of infusion included nausea, pyrexia, chills, hypotension, vomiting, and dyspnea. Most patients treated with R-FC experienced at least one Grade 3 or 4 adverse reaction. The Grade 3 or 4 adverse reactions observed more frequently with R-FC compared with FC alone were neutropenia, leukopenia, febrile neutropenia, thrombocytopenia, infusion reactions, pancytopenia, hypotension, and hepatitis B.
In clinical trials, CLL patients 70 years of age or older who received R-FC had more Grade 3 and 4 adverse reactions compared with younger CLL patients who received the same treatment.
For additional safety information, please see the full prescribing information, including BOXED WARNINGS and Medication Guide.
Attention Healthcare Provider: Provide Medication Guide to patient prior to RITUXAN infusion.
References
- Davis TA, Grillo-López AJ, White CA, et al. Rituximab anti-CD20 monoclonal antibody therapy in non-Hodgkin's lymphoma: safety and efficacy of re-treatment. J Clin Oncol. 2000;18:3135-3143.
- RITUXAN® (Rituximab) full prescribing information, Genentech, Inc., 2010.
