Piro Trial (Weekly ×8)
Up to 8 doses of RITUXAN monotherapy provided durable responses of longer than 1 year in heavily pretreated NHL patients
EXTENDED-DOSING TRIAL DESIGN: RITUXAN ×81
- Treatment in the trial consisted of RITUXAN 375 mg/m2 IV administered once weekly for a total of 8 infusions. Patients were required to have either failed to respond to primary chemotherapy or to have relapsed after chemotherapy (no more than 4 relapses).1,2
- NHL=non-Hodgkin's lymphoma.
EXTENDED-DOSING TRIAL: RELAPSED OR REFRACTORY, LOW-GRADE OR FOLLICULAR NHL1
|Patient characteristics||No. of patients (%)|
|Age range (years)||35-74|
|Histologic grade*||Low (IWF A, B, or C) Intermediate (IWF D) Other||
|Disease stage||I/II III/IV Unknown||
- *Based on the International Working Formulation (IWF).
RESPONSE DURATION IN HEAVILY PRETREATED PATIENTS1,2
- ITT=intent to treat.
- In responders (n=21), median duration of response was 13.4 months2
- Overall response rate was 57% (14% CR, 43% PR)2
- CR=complete response; PR=partial response.
Safety for single-agent RITUXAN for relapsed or refractory, low-grade or follicular NHL
- 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%)
- Piro LD, White CA, Grillo-López AJ, et al. Extended rituximab (anti-CD20 monoclonal antibody) therapy for relapsed or refractory low-grade or follicular non-Hodgkin's lymphoma. Ann Oncol. 1999;10:655-661.
- RITUXAN® (Rituximab) full prescribing information, Genentech, Inc., 2012.
RITUXAN® (Rituximab) is indicated for the treatment of patients with:
- Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
- Previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to RITUXAN in combination with chemotherapy, as single-agent maintenance therapy
- 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
- Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)
RITUXAN is not recommended for use in patients with severe, active infections.
Important Safety Information
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.
Warnings and Precautions
RITUXAN has also been associated with other serious and/or fatal adverse reactions. These include
- hepatitis B reactivation with fulminant hepatitis; hepatic failure resulting in death
- serious, including fatal, bacterial, fungal, and new or reactivated viral infections
- cardiovascular events, including serious or life-threatening cardiac arrhythmias
- severe, including fatal, renal toxicity
- abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur in patients receiving RITUXAN in combination with chemotherapy
Additional Important Safety Information
- The most frequent Grade 3 or 4 adverse reactions observed in NHL were cytopenias, including lymphopenia. 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 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 CLL 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
Attention Healthcare Provider: Provide Medication Guide to patient prior to RITUXAN infusion.