In a nutshell
The study evaluated the long-term effectiveness and safety of Ofatumumab (Arzerra) and chlorambucil (Leukeran) (CHL) in patients with previously untreated chronic lymphocytic leukemia (CLL). The authors found that the combination therapy safely improved clinical outcomes in such patients in 5 years, compared to chlorambucil alone.
Some background
Patients with CLL commonly receive fludarabine (Fludara)-based therapy as a front-line or initial treatment. Fludarabine is toxic for elderly and unfit patients. Chlorambucil (CHL) is commonly prescribed for these patients instead.
Recently, the immunotherapeutic drug ofatumumab was added with CHL to treat such patients. This chemoimmunotherapy (CIT) reduced risks of cancer-related death by 43% in 28.9 months. However, the long-term benefits of this combination therapy are unclear.
Methods & findings
The study included 447 adult patients with untreated CLL who were unfit for fludarabine. 221 patients were given CIT with ofatumumab and CHL and 226 received CHL alone. They were followed up for 5 years.
Overall, 68.5% of patients from the CIT group and 65.7% of patients in the CHL group were estimated to survive for 5 years. CIT slightly reduced the risks of leukemia-related mortality by 12%, compared to CHL alone.
The average survival without cancer getting worse was 23.39 months in the CIT group and 14.72 months in the CHL-alone group. CIT was associated with a 39% reduced risk of cancer getting worse compared to CHL alone.
Overall, 96% in the CIT group and 90% in the CHL group had side effects. Serious side effects occurred in 64% of the CIT group and 48% of the CHL group. In both groups, the most common serious side effects conditions were pneumonia, anemia, and low levels of platelets and white blood cells.
The bottom line
The study concluded that ofatumumab and CHL were safe and effective in patients with CLL who were previously unfit for fludarabine-based therapy.
The fine print
This study received funding support from Novartis, the manufacturer of ofatumumab.
Published By :
British Journal of Haematology
Date :
Mar 31, 2020
