The background of our study is the challenging of treating patients with diffuse large B-cell, elderly and frail with a comprehensive geriatric assessment that we use on the basis of previous comprehensive geriatric assessment assessed. We share the patients on the basis of three scales – fit, unfit and frail – on the basis of the ADL, activity of daily life, the instrumental activity of daily life, and the comorbidities and obviously the age.
We treat in our protocol the frail patients, the worst category – patients who had lost two or more ADL, three or more IADL and have comorbidities severe. So these patients are a really challenged population because the toxicity of normal treatment is too high for them.
What was the methodology used in this study?
We started on the basis of the good profile of safety and efficacy of lenalidomide that we know that has direct action against the tumour cells and has an immunomodulatory efficacy and an expansion block of the vascular endothelial growth factor. We well know that the activity of lenalidomide is increased with [??] rituximab. This is the backbone of our study, our treatment.
What were your findings?
Our key finding in these patients is the overall response rate. We know that the outcome in frail patients affected by diffuse large B-cell lymphoma is really poor and only 27% of patients are alive after one year. This is the first one. We have in our results over 45% of overall survival at two years in the whole population and over 60% of progression free survival in those who responded with a complete or partial response. This is a good result and this is an advance in this kind of patient.
How can these results impact the future treatment of B-cell lymphoma?
We think that the chemo-free approach in this kind of patient deserves further experimentation and further exploration because the normal chemotherapy is not available for these patients. So we think that this is the first step for a new philosophy of treatment in this kind of patient.
Is there anything else important that you would like to add?
I would like to improve the supportive care in these patients. One fault of our study was not mandatory use of growth factor or other supportive care. I think that in the future the chemo-free has to be associated with a strong therapy of support.