Combining obinutuzumab, fludarabine and cyclophosphamide in the treatment of patients with chronic lymphocytic leukemia

This study aimed to investigate the safety and effectiveness of obinutuzumab in combination with fludarabine and cyclophosphamide in fit patients with chronic lymphocytic leukemia. 

This study concluded that this combination as frontline treatment is a promising option for these patients. 

Obinutuzumab (Gazyva) is a targeted therapy used to treat chronic lymphoid leukemia (CLL) patients who were previously untreated. Fludarabine (Fludara) is a chemotherapy. Cyclophosphamide (Cytoxan) is a chemotherapy used to suppress the immune system.  

It was not known if the combination of obinutuzumab with fludarabine and cyclophosphamide (G-FC) would be safe and effective in fit, previously untreated CLL patients.  

This study involved 140 patients with CLL who were fit and had not received prior treatment. Patients received G-FC treatment. The main outcomes measured were safety and tolerability. Effectiveness was another outcome measured.  

87.1% of patients experienced severe side effects. Of these patients, 67.1% experienced neutropenia (low levels of white blood cells) and 17.1% experienced thrombocytopenia (low blood platelet count).  

Serious side effects were experienced by 42.1% of patients. These included neutropenia with (6.4%) and without fever (15.7%), pneumonia and fever (5.7% each). Severe infusion-related reactions (due to the injection of drugs) occurred in 19.3% of patients and infusion-related infections in 15.7%.  

The overall response rate was 90%. 46.4% of patients achieved a complete response (CR – no evidence of cancer). Minimal residual disease negativity (no cancerous cells left after treatment) rates were 64.3% in blood and 35.7% in the bone marrow.  

After an average follow-up time of 25.6 months, the 2-year progression-free survival (survival without the disease getting worse) rate was 91%. 

This study concluded that frontline G-FC therapy represents a promising treatment option for fit patients with CLL. 

This study received funding support from F. Hoffmann-La Roche Ltd, the manufacturer of obinutuzumab.