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Interview with Dr. Hervé Dombret - EHA 2014

University Institute of Hematology, Paris, France

Interview by Dr. J. Valentin García Gutiérrez, Hospital Universitario Ramón y Cajal, Madrid, Spain, with Dr. Hervé Dombret, Director at University Institute of Hematology, Paris, France.

 

Dr. Dombret has just presented data of a clinical trial with patients over 65y of age with acute myeloid leukemia (AML) that were randomized to receive conventional treatment (patients could choose from: intensive chemotherapy, low-dose Ara-C or best supportive care only) or chemotherapy against Vidaza (azacitidine for injection). The main study conclusions are:

Clinical significant median overall survival is in patients with primary or secondary ML in this age group, when they receive azacitidine as single treatment, as compared to different kinds of conventional care regimens.

Median age of the patients was 75y, probably because younger patients are more suitable for intensive conventional treatment. Especially for this age group, quality of life (QoL) is very important, as not many patients at that age can be cured (favourable cytogenetic backgrounds were not included in this study). The maximum benefit is an increase in median survival and ensuring a good QoL. With azacitidine, no difference was seen with respect to safety compared to Ara-C. Not all data have yet been analysed, e.g. data on hospitalization, transfusion, and QoL questionnaires still need to be included.

Treatment with azacitidine new standard of care?

Question: Should this new treatment become the new standard of care? That depends on your point of view: are you a doctor, or a patient, or regulatory person? For me, as doctor, providing 4 months extra median survival is significant. We do not cure the patient, but currently there is no other treatment capable of doing that. Significant improvement in survival time was seen compared to low-dose Ara-C and best supportive care, and even compared to intensive chemotherapy, the effect was very similar.

On patient selection, we should probably first look at the more favourable patient, in regards to condition and disease characteristics, with favourable cytogenetics and/or genotypes. Such patients are most likely to receive an intensive chemotherapy. However, the fast majority of patients in this age group, which do not tolerate such intensive treatment, or have intermediate or poor cytogenetics, alternatives are needed, such as azacitidine. We did subset analysis to see if certain patients may benefit more from this novel treatment, and it might be that patients with poor cytogenetics benefit more. Even though this is not yet fully demonstrated, it is an important issue for doctors and patients to keep in mind, at this point.

Could shorter treatment with azacitidine also work? 

Question: The current regimen is 7 days azacitidine in a row. Could this also work as 5 days treatment, followed by a 2 day treatment (after the weekend)? Although formally this cannot be answered yet, as it was not studied, based on experience the answer most probably would be ‘yes’.


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