In a nutshell
This study evaluated the safety and effectiveness of lenalidomide (Revlimid) plus R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy in previously untreated patients with follicular lymphoma (FL) and a high tumor burden (a large number of cancer cells or tumors in the body). This study concluded that this regimen was effective and well-tolerated in these patients.
The current standard first-line treatment for patients with FL is immunochemotherapy. This type of treatment combines immunotherapy and chemotherapy to stimulate the immune system to attack and destroy cancer cells. R-CHOP is the current regimen of choice for first-line (primary) treatment of FL.
Lenalidomide is an immunomodulatory drug. This type of treatment boosts the body’s immune system to help it attack cancer cells. This leads to cancer cell death. The safety and effectiveness of lenalidomide combined with R-CHOP for previously untreated patients with FL and a high tumor burden remain under investigation.
Methods & findings
This study involved 80 patients with previously untreated FL. 93% of patients had stage 3 – 4 disease. Patients received lenalidomide plus R-CHOP (R2-CHOP). Maintenance therapy (treatment to prevent relapse) with rituximab (Rituxan) was given over 2 years to patients who responded to the study treatment. Patients were followed-up for an average of 45 months.
Overall, 94% of patients responded to treatment. 74% of patients achieved a complete response (disappearance of all signs of cancer). This rate was 69% at 30 months after treatment.
At follow-up, 22% of patients experienced disease progression (tumor grows or spreads) or relapse. 3-year progression-free survival (patients alive 3 years later without disease progression; PFS) was 79%. Patients who achieved a complete response had a 3-year PFS of 86%. 3-year overall survival (patients still alive 3 years later) was 95%.
The most common mild to moderate side effects included numbness and tingling in the hands or feet (35%) and rash (34%). The most common life-threatening side effect was low white blood cell count (65%). 7% of patients reported severe to life-threatening low white blood cell count with fever.
7.5% of patients stopped lenalidomide due to side effects.
The bottom line
This study concluded that lenalidomide plus R-CHOP was effective and well-tolerated in patients with FL and a high tumor burden.
The fine print
This was a Phase 2 study. Further studies are needed to determine the role of lenalidomide plus R-CHOP in patients with high-risk FL.
Published By :
The Lancet. Haematology
Sep 01, 2018
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