People in treatment for chronic lymphatic leukaemia (CLL) could in future bypass the uncomfortable effects of chemotherapy. New research from Danish hospitals and others shows that targeted treatment could replace chemotherapy, which until now has been part of the first-line treatment. The results have been published in the prestigious New England Journal of Medicine.
In the GAIA/CLL13 study, researchers have tested various combinations of treatment for CLL, and the results show that a combination of targeted venetoclax treatment and a monoclonal antibody gives better disease control for patients, with fewer side effects and fewer late complications. Consultant Carsten Utoft Niemann from the Department of Haematology at Copenhagen University Hospital - Rigshospitalet is the chair of the specialist CLL group in the Nordic countries, and he has helped to carry out the study.
“The study shows that, after targeted treatment, patients on average have longer survival times without disease, and several achieve disease control without visible residual disease. At the same time, there are fewer side effects, such as infections, than with chemotherapy. Our results underpin the paradigm shift that we now have a new first-line treatment for patients with chronic lymphatic leukaemia,” says Carsten Utoft Niemann.
He explains that venetoclax works by blocking the protein BCL2. This is used by cancer cells to protect against natural death, and it enables them to proliferate uncontrolled. Chemotherapy treatment can remove cells that divide, but it does not necessarily strike dormant cancer cells. Venetoclax is designed to be more gentle to healthy cells, as it primarily targets all sick cells, irrespective of whether or not they are dividing.
Only for one out of ten patients
Until now, the Danish Medicines Council has only recommended venetoclax for a small sub-group of patients with CLL with mutation of the TP53 gene, and this applies for around one in ten patients (approx. 20-25 a year in Denmark). However, in the Danish national guidelines, experts have recommended using venetoclax for a larger group with either mutation in TP53 or unmutated IGVH, which is the most frequent type of CLL. This recommendation has now been backed up by the new research results.
The study was conducted as a randomised study of 920 CLL patients. Of these, 100 patients were Danish. Patients were treated with either chemotherapy or venetoclax in combination with one of the two different monoclonal antibodies (obinutuzumab or rituximab). All the Danish regions took part in the study, together with German, Dutch and Nordic researchers.