In a nutshell
This study evaluated the safety and effectiveness of the BR regimen (rituximab, bendamustine) in elderly patients with untreated low-tumor burden follicular lymphoma (LTBFL). This study concluded that the BR regimen may provide positive outcomes for these patients.
Some background
Low-tumor burden follicular lymphoma (LTBFL) is a type of lymphoma characterized by tumors smaller than 7 centimeters. The typical approach is a watch-and-wait strategy, where patients are monitored instead of receiving active treatment.
However, some patients with LTBFL may have high-risk disease. These patients may benefit from more intense treatment, such as the BR regimen. Previous studies have investigated the outcomes of other patients with FL with this regimen. The safety and effectiveness of BR in patients with untreated LTBFL remains under investigation.
Methods & findings
This study involved 63 elderly patients with previously untreated LTBFL. 98.4% of patients had stage 3 – 4 disease. 69.8% of patients had high-risk disease. Patients received two cycles of BR as a first-line treatment. After initial treatment, patients received rituximab as maintenance therapy (treatment to delay relapse). Patients were followed-up for an average of 52 months.
Overall, 95.2% of patients responded to treatment at 12 weeks. 57.1% of patients achieved a complete response (disappearance of all signs of cancer). At the end of treatment, including maintenance therapy, 66.7% of patients achieved a complete response.
The progression-free survival (PFS; patients still alive at 2 years without a return of disease) rate after two years for all patients was 85.4%. Certain factors impacted PFS. A high rituximab dose was associated with an 11.3% higher PFS. The presence of large tumors (bigger than 6 centimeters) before starting treatment was associated with a significantly lower PFS (4.8-fold).
Most side effects were mild. During treatment with BR, low red blood cell count (51.6%) and low white blood cell count (54.8%) were the most commonly reported side effects. During rituximab maintenance therapy, patients reported low red blood cell count (22.6%) and low white blood cell count (46.8%).
The bottom line
This study concluded that the BR regimen may provide positive outcomes for elderly patients with LTBFL. The authors suggest that this regimen may not be recommended for all patients, especially those with high-risk disease.
The fine print
After 6 months, all patients immediately stopped treatment due to 3 treatment-related deaths. 56 patients withdrew from the study early.
This study received funding support from Roche and Mundipharma, the manufacturers of rituximab and bendamustine.
Published By :
British Journal of Haematology
Date :
Aug 16, 2018