In a nutshell
This study examined whether maintenance (long-term) therapy with rituximab (Rituxan) was safe and effective in patients with follicular lymphoma. This study concluded that rituximab improved progression free survival (time from treatment until disease progression).
Some background
Follicular lymphoma is the second most common form of non-Hodgkin lymphoma. Patients often experience relapses after treatment, and most require systemic therapy, such as chemoimmunotherapy. A combination of chemotherapy and rituximab is now the standard treatment option. Rituximab is a monoclonal antibody that attaches to the CD20 protein found on cancer cells. This leads to cancer cell death. Long-term (2 years) of rituximab maintenance therapy has been shown to be effective in patients who have already experienced a relapse. It is not clear whether it is as effective after first-line chemoimmunotherapy.
Methods & findings
In this study, 1018 patients were randomly assigned to rituximab maintenance treatment (group 1, 505 patients) or observation (group 2, 513 patients). All patients were first treated with 6–8 cycles of chemotherapy and rituximab. Group 1 then received 12 more doses of rituximab every 8 weeks. Patients were followed for an average of 36 months.
Three-year progression-free survival was 74.9% in group 1. This was significantly higher than for group 2 (57.6%). The risk of progression was 46% lower for group 1.
By the end of the maintenance phase, 71.5% of patients in group 1 were in complete remission (no sign of active disease) compared to 52.2% of group 2. Overall survival (time from treatment until death from any cause) did not differ between the groups.
Adverse effects were experienced by 56% of group 1 and 37% of group 2. The most common were infections.
The bottom line
This study concluded that 2 years of rituximab following chemotherapy is an effective treatment for FL.
The fine print
This study was funded by F Hoffman-La Roche, one of the manufacturers of rituximab.
Published By :
Lancet (London, England)
Date :
Jan 01, 2011