World’s largest clinical trial in follicular lymphoma gives hope to patients



An international collaborative study, including researchers at Monash University, has shown that follicular lymphoma patients treated with a therapy known as obinutuzumab in combination with chemotherapy leads to significant improvements in how the disease is controlled.

Published last week in the prestigious New England Journal of Medicine, the results from the largest ever follicular lymphoma clinical trial revealed that patients treated with a combination of chemotherapy and obinutuzumab had their disease under control for one and a half times longer than the standard treatment with chemotherapy and rituximab.

Non-Hodgkin lymphoma (NHL) is the sixth most common form of cancer, affecting 1 in 40 people.  NHL is categorised into two main types: aggressive and indolent.

“In aggressive NHL, the lymphoma cells divide quickly and patients die within months if untreated, however, most have a high chance of cure with chemotherapy,” Head of Haematology at Monash University and Monash Health, Professor Stephen Opat said.

“Follicular Non-Hodgkin lymphoma is the main subtype of indolent NHL, a disease where lymphocytes (the immune cells that cause lymphoma) don’t die and gradually accumulate in the lymph nodes, bone marrow and tissues,” Professor Opat, senior author on the study said.

While indolent NHL patients can live for many years untreated, the disease is considered incurable with chemotherapy, and treatment is generally reserved for patients with symptoms.

Professor Opat said these patients often have an extended period of disease control with chemotherapy, however the majority will eventually relapse needing further therapy.

The Gallium study was the largest clinical trial ever conducted in follicular lymphoma, comparing the safety and effectiveness of two different anti-lymphoma antibodies (rituximab and obinutuzumab) in combination with chemotherapy for patients with previously untreated follicular lymphoma.

1202 patients—including 30 at Monash Health, the largest recruitment site in Australia—were randomly selected to receive chemotherapy with rituximab or chemotherapy with obinutuzumab.

“Those patients who responded could have up to two years of maintenance treatment with rituximab or obinutuzumab to keep their disease in remission for as long as possible,” Professor Opat said.

After three years of follow up, more patients are still alive with their lymphoma under control in the obinutuzumab group (80 of every 100) than the rituximab group (73 of every 100).

“This translates into a 1.5-times longer time that their lymphoma is in remission with obinutuzumab compared with the rituximab—perhaps offering an additional three years before needing to be treated again,” Professor Opat said.

While the obinutuzumab-treated patients had a longer period of lymphoma control they also reported more frequent adverse effects of therapy including infections (20% versus 16% with Rituximab) and reactions to the antibody infusion (12% versus 7% with rituximab).

“Chemotherapy with obinutuzumab resulted in a meaningful improvement in the duration of disease control and is an important addition to the treatment options for patients with follicular lymphoma.”