Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program.
- Study type
- Clinical trial
- Study name
- IDEC-C2B8
- Design
- Multicentre single-group trial (no control group) with intention-to-treat analysis
- Sample size
- 166 patients from 31 centres
- Source
- JCO · 1998
In plain words
In this study, the drug rituximab, a targeted antibody against the CD20 protein on lymphoma cells, was given to patients with slow-growing (indolent) lymphoma that had come back. The drug was given as an infusion once a week, four times in total. About half of the patients (48%) responded to treatment. Most side effects were mild to moderate and occurred mainly during the first infusion, as fever and chills.
Key results
Treatment arms and regimens
Outpatient course of IDEC-C2B8 375 mg/m² IV weekly, four doses in total.
Source of the regimen details: Abstract of the paper
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Patients with relapsed low-grade or follicular lymphoma.
Endpoints
Response rate in the intention-to-treat population and time to progression in responders; serum antibody levels, adverse events and formation of human antichimeric antibody were also assessed.
Safety and side effects
Most adverse events occurred during the first infusion and were grade 1 or 2; fever and chills were the most common. Only 12% of patients had grade 3 and 3% grade 4 adverse events. Human antichimeric antibody was detected in only one patient.
Clinical significance and place in guidelines
This study showed that rituximab alone has substantial activity in relapsed indolent lymphoma (48% response) with mostly mild toxicity, and its results are comparable with single-agent chemotherapy. The authors stressed further research, including combination with standard chemotherapy. The current status of approvals and guideline recommendations should be checked separately, as the abstract does not address them.
Limitations
The study was single-group without a control group. Follow-up was relatively short (median 11.8 months), and the time to progression is projected. The comparison with chemotherapy is only indirect.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.