In a nutshell
This study explored whether treatment with rituximab (Rituxan) improved outcomes and quality of life compared to a watch and wait approach in patients with advanced-stage, follicular lymphoma without symptoms. The authors determined that treatment with rituximab was a safe and effective treatment option.
Some background
Some patients with advanced-stage follicular lymphoma do not have any symptoms of disease. These patients may be treated with chemotherapy, which has many side effects, or they may follow a watch and wait approach. With this approach, treatment is delayed until symptoms start. Prior research has not found an improvement in overall survival (time from entering trial or treatment until death from any cause) with early chemotherapy compared to watch and wait. Some patients, however, may find it psychologically difficult to not immediately treat their cancer. This anxiety can lower quality of life.
Rituximab is a monoclonal antibody that binds to the CD20 protein present on many lymphoma cells. This leads to cancer cell death. One trial including patients with low burdon lymhoma (smaller number of cancer cells) noted that 48% of patients achieved complete molecular remission (no sign of active disease) after 4 weekly infusions. It is not clear whether rituximab could improve outcomes and quality of life in advanced stage patients without symptoms.
Methods & findings
In this study, 379 patients were randomly assigned to watch and wait (group 1) or 4 weekly infusions of rituximab followed by 12 more infusions delivered every two months as maintenance treatment (group 2). 84 other patients were treated with 4 weekly infusions of rituximab (group 3) Patients were followed for an average of 46–50 months.
59% of group 2 patients had a complete response after 7 months. 75% had a complete response after 25 months. In comparison, 6% of group 1 had a spontaneous complete response.
56% of group 1 eventually needed treatment. 17% of group 2 needed new treatments. 3-year progression free survival (PFS) rates (time from treatment until disease progression) were 36% in group 1 and 82% in group 2. In group 3 patients, 3-year PFS was 60%.
Patients in group 2 reported significantly better quality of life than patients in group 1. There were 14 serious adverse effects in group 2, including infections, allergic reactions, and low white blood cell levels. All were resolved.
The bottom line
This study concluded that rituximab was safe and effective in patients with non-symptomatic advanced-stage follicular lymphoma. Longer-term treatment was more effective than short-term.
Published By :
The Lancet. Oncology
Date :
Apr 01, 2014
