ASCO 2010 Annual Meeting, 4—8 June 2010, Chicago
Interview with Professor Gilles Salles (Universite Claude Bernard Lyon, France)
The Prima study
Tomorrow, I will present the results of the PRIMA study, which is a large international study that addresses the benefit of Rituximab as a maintenance treatment in patients with follicular lymphoma that were in need of therapy. Basically, 1,200 patients that were in need of immediate treatment received first an immuno-chemotherapy standard regime, R-CHOP or R-CVP, and were then randomised between observation or maintenance with Rituximab: one infusion every two months for two years.
The major finding of this study is that patients that received the Rituximab maintenance had a 50% reduction in the risk of lymphoma recurrence as opposed to those that were in the observation. This is in line with secondary endpoint signs like the time to the next chemo regime and the improvement of the response rate at the end of maintenance.
What is the toxicity profile of this treatment regime?
The toxicity that was observed is in line with what is already known with Rituximab – an increased rate of infection which will mostly upgrade to infections or common infection. Actually, the study was feasible: the majority of patients remained on the study, we had very few drop out and we also have quality of life data clearly indicating that the quality of life of patients that received either Rituximab maintenance or observation was similar. So I think very mild toxicity, very well tolerated, is a benefit in terms of disease control.
How does the patient benefit from this new treatment?
Patients with follicular lymphoma have a disease that tends to recur over time and as physicians we need to develop treatments that will prevent a rapid recurrence of the disease and prolong the time without treatment while preserving the quality of life of patients. In this study we have administered to patients one infusion of a drug called Rituximab every two months to two years in patients that had received an induction, a first treatment, with chemotherapy and Rituximab. What we found is that these treatments that we called maintenance with Rituximab, again one infusion every two months, was able to delay the time of disease recurrence and to delay the time to start a new chemotherapy in those patients. Therefore it does provide a better control of the disease over time, preserving the quality of life of patients which I believe is a significant finding for those.
What is the outlook for elderly patients diagnosed with cancer?
I do think that at the present time patients that are over sixty, over seventy and sometimes over eighty have a quality of life in general which is good and a health status, once they develop cancer, that remains good for some of them. In these patients, given the progress we have achieved with some new treatments in different fields, I do think that we do have to offer these patients the same chance of either being cured or having the optimal treatment as younger patients. Obviously this is true for patients over sixty, seventy and it can be true in certain patients over eighty. In those that have a health state that is compromised we need to develop specific treatments also using these new agents that will control the disease with low toxicity.
